EXCIPIENTS ppt

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EXCIPIENTS :

EXCIPIENTS BY: JAIDEEP R. DHAGE M.PHARM SEM-1 J.L.CHATURVEDI COLLEGE OF PHARMACY

1) Overview/Introduction of Excipients :

Definition: These are the agents or substances which have no or little therapeutic activity but are included along with the drug being formulated in a dosage form so as to impart specific qualities to them. OR any substance other than the active drug or prodrug which has been appropriately evaluated for safety and is included in a drug delivery system to either: 1. aid processing of the system during manufacture, or 2. protect, support or enhance stability, bioavailability or patient acceptability, or 1) Overview/Introduction of Excipients

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3. assist in product identification, or 4. enhance any other attribute of the overall safety and effectiveness of the drug product during storage or use. Excipients are the additives used to convert pharmacologically active compounds into pharmaceutical dosage forms suitable for administration to patients. Although excipients are the non-active ingredients, they are essential in the successful production of acceptable dosage forms such as tablets. For example, the lack of filling materials would make it exceedingly challenging to produce a 1mg dose tablet of a potent drug.

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Ideal Characteristics of excipients It should be compatible with drug and other ingredients. It should be compatible with primary packaging materials. It should not creat any bioavaibility problems. It should not be toxic. It should be chemically and physically inert. It should be organoleptically acceptable.

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Advantages of using excipients : It improves the wetting property (surfactants). Hydrocolloids may serve the purpose of emulsifying, binding, gel forming agents. Increases the bulk of the drug. Provide stabilization of formulation(It serves as ph adjuster, chelating agent, anti-oxidant). Improves organoleptic properties. It serves as vehicle for formulation.

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Disadvantages of using excipients : May cause chemical interaction with drug (example: amphetamine + sod. CMC = produce undesirable compex ). Can cause bioavailability problems ( phenobarbital + oily vehical = cause less drug release). Can interact with packaging material to affect active ingredient.

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Classification of excipients on the basis of dosage form: A) Solid dosage form: Tablets Diluents – lactose, mannitol , starch, sucrose, dextrose etc. Binders – acacia, sorbitol , tragacanth , sodium alginate, starch paste etc. Disintegrants – starch, cellulose, alginates, microcrystalline cellulose, sodium starch glycolate , citric acid, tartaric acid etc. Lubricants – stearic acid and its salts, talc, polyethylene glycol, mineral oil etc.

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5. Glidants and flow promoters – silica, talc, corn starch etc. 6. Colours – It may be natural or synthetic colours . Natural colours are classified as: mineral – titanium dioxide, carbon black, prussian blue etc. plant origin – chlorophyll, carotene, indigo etc. Animal origin – carminic acid (from coccus cacti), tyrian purple (from snail) etc. Synthetic colours are classified as: Natural – annatto, carotene, red oxide of iron, yellow oxide of iron etc. Artificial – caramel. Coal for colours – green(green s, quinazarine green ss ), yellow(sunset yellow, tartrazine ), red(amaranth, erythrocin ), blue(indigo, brilliant blue), orange(orange g).

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7. Sweetners – sugar, saccharin, liquid glucose, cyclamates etc. 8. Flavours – menthol, cadamom , ginger, pineapple, orange etc. These flavours may be ester, methyl salicylate , alcoho , glycerine & aldehyde in chemical nature. 9. Tablet coating excipients – For sealing – shellac, cellulose acetate phthalate etc. For sub-coating – sucrose, corn syrup, acacia, gelatin, talc, calcium carbonate etc. For polishing – bees wax, carnauba wax, chlorinated wax etc. Film forming – polyvinylpyrrolidone , polyvinyl alcohol, CMC, MC, HPC, EC etc.

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Capsules Body of capsule- gelatin. Diluents – lactose, mannitol , sorbitol , starch. Glidant – talc. Antidusting agent – inert edible oil. Polishing agent – crystalline sodium chloride. Sealing and locking – water, acacia mucilage. B) Semi-solid dosage forms (ointments, suppositories, creams, pastes). 1. Bases : Hydrocarbon – microcrystalline wax, paraffin wax, petrolatum etc. Vegetable oils – sesame oil, olive oil, peanut oli etc.

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Animal fat – bees wax, lanolin, spermaceti wax etc. Alcohols – cetyl alcohol, stearyl alcohol, lauryl alcohol etc. Acids – stearic acid, oleic acid, palmitic acid, myristic acid etc. Esters – isopropyl myristicate , ethylene glycol, ethyl oleate etc. Preservatives – benzoic acid, phenol, phenyl mercuric nitrate, salicylic acid. Antioxidants – BHA, BHT, ascorbic acid, tocopherol , sodium bisulfite . C) Liquid dosage forms: Syrup, suspension, emulsion & other liquid forms:

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1. Aqueous vehicle – distill & purified water(water for injection), syrup (acacia syrup, cherry syrup, cocoa syrup) 2. Hydroalcoholic liquid – glycyrrhiza elixir, aromatic elixir. 3. Alcoholic liquids – lemon tincture, orange tincture, peppermint spirit. 4. Oily vehicle – cottonseed oil, castor oil, sesame oil. 5. Surfactants – sodium lauryl sulphate , benzalkonium chloride, lauryl , cetyl and stearyl aalcohols . 6. Flavours - menthol, cadamom , ginger, pineapple, orange etc. These flavours may be ester, methyl salicylate , alcoho , glycerine & aldehyde in chemical nature.

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7. Sweetners – sugar, saccharin, liquid glucose, cyclamates etc. 8. Colours – It may be natural or synthetic colours . Natural colours are classified as: mineral – titanium dioxide, carbon black, prussian blue etc. plant origin – chlorophyll, carotene, indigo etc. Animal origin – carminic acid (from coccus cacti), tyrian purple (from snail) etc. Synthetic colours are classified as: Natural – annatto, carotene, red oxide of iron, yellow oxide of iron etc. Artificial – caramel. Coal for colours – green(green s, quinazarine green ss ), yellow(sunset yellow, tartrazine ), red(amaranth, erythrocin ), blue(indigo, brilliant blue), orange(orange g).

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9. Preservatives – benzoic acid, phenol, phenyl mercuric nitrate, salicylic acid. 10. Antioxidants – BHA, BHT, ascorbic acid, tocopherol , sodium bisulfite . Injectables : Vehicle – sterile waterfor injection, purified water, ethyl alcolhol , glycerine , PEG, peanut oil , seasem oil, cottonseed oil. Stabilizer – EDTA Buffer – salts of acetate, citrate, phosphates. Antioxidants – sodium bisulphite . Preservatives – benzoic acid, phenol, phenyl mercuric nitrate, salicylic acid, chlorobutol .

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Tonicity contributors – sodium chloride, borax Wetting, suspending & emulsifying agent – tween-80, pluronic F-68, sorbitan trioleate , CMC, PVP, lecithin.

2) Factor affecting the selection of excipients:

The various factors are as follows: 1. Influence of excipient on the overall quality, stability, and effectiveness of drug product. 2. Compatibility of excipient with drug and the packaging system. 3. Compatibility of excipient with the manufacturing process. For example, preservatives may be adsorbed by rubber tubes or filters, acetate buffers will be lost during lyophilization process, etc. 4. The amount or percentage of excipients that can be added to the drug product. Example cresol and phenol in conc. of 0.5% 5. Route of administration. 2) Factor affecting the selection of excipients

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5. Cost 7. Suitability of excipient with patients. Example Dimethyl sulfoxide can cause stomach upset, diarrhea, drowsiness, and headache. Lactose unsuitable for people with lactose insufficiency, galactosemia , or glucose/ galactose malabsorption syndrome. Organic mercury compounds can cause kidney damage Parahydroxybenzoate and their esters known to cause urticaria . Generally delayed type reactions, such as contact dermatitis Phenylalanine Harmful for people with phenylketonuria

3) Package – excipient interaction :

The various interactions are: Leaching Permeation Sorption Chemical reaction Modification of the physical characteristics of the product The best known example of excipient adsorption or absorption is the lossof antimicrobial preservative from solutions to container/closure systems, most notably the rubber bungs of multidose injection containers, or the rubber gaskets used in metered dosenasal pumps. The effective concentration in solution can be reduced to such an extent that theproduct is no longer protected from microbial growth. 3) Package – excipient interaction

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There is also the possibility of constituents from lubricants migrating through polyethylene or polypropylene containers.

Cyclodextrins :

Cyclodextrins are cyclic oligosaccharides which is useful pharmaceutical excipients . It is a molecular inclusion compounds involve the entrapment of a single guest molecule in the cavity of one host molecule. The molecular structure of these glucose derivatives, which approximates a truncated cone or torus, generates a hydrophilic exterior surface and a nonpolar cavity interior. As such, cyclodextrins can interact with appropriately sized molecules to result in the formation of inclusion complexes. These noncovalent complexes offer a variety of physicochemical advantages over the unmanipulated drugs including the possibility for increased water solubility and solution stability. Further, chemical modification to the parent cyclodextrin can result in an increase in the extent of drug complexation and interaction. Cyclodextrins

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Cyclodextrins are frequently regarded as a new group of pharmaceutical excipients , These carbohydrates are mainly used to increase the aqueous solubility, stability, and bioavailability of drugs, for example, be used to convert liquid drugs into microcrystalline powders, prevent drug-drug or drug additive interactions, reduce gastrointestinal or ocular irritation,and reduce or eliminate unpleasant taste and smell. 1) Chemical nature of cyclodextrin Cyclodextrins are cyclic (R-1,4)-linked oligosaccharides of R-D- glucopyranose containing a relatively hydrophobic central cavity and hydrophilic outer surface.

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The primary hydroxyl groups are located on the narrow side of the torus while the secondary hydroxyl groups are located on the wider edge. The most common cyclodextrins are alpha- cyclodextrin , beta- cyclodextrin , and gamma- cyclodextrin , which consist of six, seven, and eight glucopyranose units, respectively.

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2) Applications in Pharmaceutical Formulation Cyclodextrins are crystalline, nonhygroscopic , cyclic oligosaccharides derived from starch. Among the most commonly used forms are α-, β-, and γ- cyclodextrin . The internal surface of the cavity is hydrophobic and the outside of the torus is hydrophilic; this is due to the arrangement of hydroxyl groups within the molecule. This arrangement permits the cyclodextrin to accommodate a guest molecule within the cavity, forming an inclusion complex.

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Cyclodextrins may be used to form inclusion complexes with a variety of drug molecules, resulting primarily in improvements to dissolution and bioavailability owing to enhanced solubility and improved chemical and physical stability. Cyclodextrin inclusion complexes have also been used to mask the unpleasant taste of active materials and to convert a liquid substance into a solid material. β- Cyclodextrin is the most commonly used cyclodextrin , although it is the least soluble. It is the least expensive cyclodextrin and is commercially available from a number of sources and is able to form inclusion complexes with a number of molecules of pharmaceutical interest. However, β- cyclodextrin is nephrotoxic and should not be used in parenteral formulations but it is considered non-toxic when taken orally and used in tablet and capsules.

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In oral tablet formulations, β- cyclodextrin may be used in both wet-granulation and direct compression processes. α- Cyclodextrin is used mainly in parenteral formulations. It has the smallest cavity of the cyclodextrins it can form inclusion complexes with only relatively few, smallsized molecules. γ- cyclodextrin has the largest cavity and can be used to form inclusion complexes with large molecules; it has low toxicity and enhanced water solubility. Cyclodextrins are starch derivatives and are mainly used in oral and parenteral pharmaceutical formulations.

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They are also used in topical and ophthalmic formulations. Cyclodextrins are also used in cosmetics and food products In eye drop formulations, parent cyclodextrins form water-soluble complexes with lipophilic drugs such as corticosteroids. They have been shown to increase the water solubility of the drug; to enhance drug absorption into the eye; to improve aqueous stability; and to reduce local irritation. 3) Pharmacopeial specifications for β- cyclodextrin ( betadex ) pH 5.0–8.0 Specific rotation +160 to +164° Microbial limits — ≤1000/ ga Sulfated ash ≤0.1% Heavy metals ≤5-10 ppm Loss on drying ≤14-16.0% Reducing sugars ≤0.2-1.0% Assay (anhydrous basis) 98.0–101.0%

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4) Stability and Storage Conditions β- Cyclodextrin and other cyclodextrins are stable in the solid state if protected from high humidity. Cyclodextrins should be stored in a tightly sealed container, in a cool, dry place. 5) Incompatibilities The activity of some antimicrobial preservatives in aqueous solution can be reduced in the presence of hydroxypropyl - β- cyclodextrin .

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6) Method of Manufacture Cyclodextrins are manufactured by the enzymatic degradation of starch using specialized bacteria. For example, β- cyclodextrin is produced by the action of the enzyme cyclodextrin glucosyltransferase upon starch or a starch hydrolysate using organic solvent. The insoluble complex of β- cyclodextrin and organic solvent is separated from the noncyclic starch. 7) Pharmacokinetic parameter Cyclodextrin administered orally is metabolized by microflora in the colon, forming the metabolites maltodextrin , maltose, and glucose; which are themselves further metabolized before being finally excreted as carbon dioxide and water.

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8) Pharmaceutical application of cyclodextrin can be explained as: 1.Enhanced solubility: increase solubility of retinoic acid. 2.Enhanced dissolution: increase dissolution rate of famotidine , tolbutamide . 3.Enhanced stability: increase stability of drugs such as aspirin, benzocaine , ehedrine etc by preventing the exposure of the functional groups to the exterior environment. 4.Sustained release: ethylated beta- cyclodextrin retards the release of diltiazem , isosorbide dinitrate , when complexed .

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Thickeners/Hydrocolloids Thickeners are high molecular weight materials of colloidal dimensions, which in water, produce highly viscous solution, suspension or gel. They impart viscosity to aqueous solution due to interactions of their molecules with water. Classification of hydrocolloids: 1.Natural hydrocolloids Plants – acacia, tragacanth , alginates Animals – gelatin ( pharmagel A, pharmagel B) Minerals- bentonite , veegum , attapulgite 2.Semisynthetic hydrocolloids – MC, CMC, hydroxyethylcellulose 3.synthetic hyrocolloids – carbapols , polyox

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Various thickeners/hydrocolloids are: Acacia: Acacia is a complex, loose aggregate of sugars and hemicelluloses with a molecular weight of approximately 240 000–580 000. The aggregate consists essentially of an arabic acid nucleus to which are connected calcium, magnesium, and potassium along with the sugars arabinose , galactose , and rhamnose . Acacia is available as white or yellowish-white thin flakes, spheroidal tears, granules, powder, or spray-dried powder. It is odorless and has a bland taste.

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Acacia is mainly used in oral and topical pharmaceutical formulations as a suspending and emulsifying agent, often in combination with tragacanth . It is also used in the preparation of pastilles and lozenges, and as a tablet binder, although it can produce tablets with a prolonged disintegration time. Acacia is incompatible with a number of substances including amidopyrine , apomorphine , cresol, ethanol (95%), ferric salts, morphine, phenol, physostigmine , tannins, thymol , and vanillin.

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Method of Manufacture: Acacia is the dried gummy exudate obtained from the stems and branches of Acacia senegal (Fam. Leguminosae ) . The bark of the tree is incised and the exudate allowed to dry on the bark. The dried exudate is then collected, processed to remove bark, sand, and other particulate matter, and graded. Various acacia grades differing in particle size and other physical properties are thus obtained. A spray-dried powder is also commercially available. Functional Category: Emulsifying agent; stabilizing agent; suspending agent; tablet binder; viscosity-increasing agent.

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2. Tragacanth : Tragacanth is a naturally occurring dried gum obtained from Astragalus gummifer . The gum consists of a mixture of water-insoluble and water-soluble polysaccharides. Bassorin , which constitutes 60–70% of the gum, is the main water-insoluble portion, while the remainder of the gum consists of the water-soluble material tragacanthin . On hydrolysis, tragacanthin yields L- arabinose , L- fucose , D- xylose , D- galactose , and D- galacturonic acid. Tragacanth gum also contains small amounts of cellulose, starch, protein, and ash. Tragacanth gum has an approximate molecular weight of 840 000.

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Description : White to yellowish in color, tragacanth is a translucent, odorless substance, with an insipid mucilaginous taste. Applications in Pharmaceutical Formulation: Tragacanth gum is used as an emulsifying and suspending agent in a variety of pharmaceutical formulations. It is used in creams, gels, and emulsions at various concentrations according to the application of the formulation. Tragacanth gum is also used similarly in cosmetics and food products, and has been used as a diluent in tablet formulations.

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Incompatibility: At pH 7, tragacanth has been reported to considerably reduce the efficacy of the antimicrobial preservatives benzalkonium chloride, chlorobutanol , and methylparaben , and to a lesser extent that of phenol and phenylmercuric acetate.

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3. Aliginic acid: Alginic acid is a tasteless, practically odorless, white to yellowishwhite , fibrous powder. Alginic acid is a linear glycuronan polymer consisting of a mixture of b-(1!4)-D- mannosyluronic acid and a-(1!4)-L- gulosyluronic acid residues, of general formula (C6H8O)n. The molecular weight is typically 20 000–240 000. Alginic acid as a mixture of polyuronic acids [(C6H8O6)n] composed of residues of D- mannuronic and Lglucuronic acid, and obtained mainly from algae belonging to the Phaeophyceae .

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Applications in Pharmaceutical Formulation Alginic acid is used in a variety of oral and topical pharmaceutical formulations. In tablet and capsule formulations, alginic acid is used as both a binder and disintegrating agent at concentrations of 1–5% w/w. Alginic acid is widely used as a thickening and suspending agent in a variety of pastes, creams, and gels; and as a stabilizing agent for oil-in-water emulsions. Alginic acid has been used to improve the stability of levosimendan . Therapeutically, alginic acid has been used as an antacid. In combination with an H2-receptor antagonist, it has also been utilized for the management of gastroesophageal reflux.

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Incompatibilities: Incompatible with strong oxidizing agents; alginic acid forms insoluble salts in the presence of alkaline earth metals and group III metals with the exception of magnesium. Method of Manufacture: Alginic acid is a hydrophilic colloid carbohydrate that occurs naturally in the cell walls and intercellular spaces of various species of brown seaweed ( Phaeophyceae ). The seaweed occurs widely throughout the world and is harvested, crushed, and treated with dilute alkali to extract the alginic acid.

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4. Gelatin: Gelatin occurs as a light-amber to faintly yellow-colored, vitreous, brittle solid. It is practically odorless and tasteless, and is available as translucent sheets, flakes, and granules, or as a coarse powder.Gelatin is a mixture of purified protein fractions obtained either by partial acid hydrolysis (type A gelatin) or by partial alkaline hydrolysis (type B gelatin) of animal collagen obtained from cattle and pig bone, cattle skin (hide), pigskin, and fish skin. Gelatin may also be a mixture of both types. The protein fractions consist almost entirely of amino acids joined together by amide linkages to form linear polymers, varying in molecular weight from 20 000–200 000.

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Applications in Pharmaceutical Formulation: Gelatin is widely used in a variety of pharmaceutical formulations, including its use as a biodegradable matrix material in an implantable delivery system. Gelatin capsules are unit-dosage forms(capsules, pills, suppositories) designed mainly for oral administration. Gelatin is soluble in warm water (>30 0 C), and a gelatin capsule will initially swell and finally dissolve in gastric fluid to release its contents rapidly. Gelatin is also used for the microencapsulation of drugs. Gelatin is also widely used in food products and photographic emulsions.

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Low-molecular-weight gelatin has been investigated for its ability to enhance the dissolution of orally ingested drugs. Ibuprofen–gelatin micropellets have been prepared for the controlled release of the drug. Other uses of gelatin include the preparation of pastes, pastilles, pessaries , and suppositories. In addition, it is used as a tablet binder and coating agent, and as a viscosity-increasing agent for solutions and semisolids. Therapeutically, gelatin has been used in the preparation of wound dressings and has been used as a plasma substitute.

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Absorbable gelatin is available as sterile film, ophthalmic film, sterile sponge, sterile compressed sponge, and sterile powder from sponge. Gelatin sponge has hemostatic properties. Method of Manufacture: Gelatin obtained from the acid process is called type A, whereas gelatin obtained from the alkali process is called type B. The soft bone is cut in pieces and washed in cold water for a few hours to remove superficial fat. It is then treated with mineral acid solutions, mainly HCl or H2SO4, at pH 1–3 and 15–20 0 C until maximum swelling has occurred. This process takes approximately 24 hours. The swollen stock is then washed with water to remove excess acid, and the pH is adjusted to pH 3.5–4.0 (pigskin, fish skin) or 2.0–3.5 (all other tissues) for the conversion to gelatin by hot-water extraction.

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The hydrolytic extraction is carried out in a batch-type operation using successive portions of hot water at progressively higher temperatures (50–75 0 C) until the maximum yield of gelatin is obtained. The gelatin solution is then filtered and sterilised . In the alkali process (liming), demineralized bones ( ossein ) or cattle skins are usually used. The animal tissue is held in a calcium hydroxide (2–5% lime) slurry for a period of 2–4 months at 14–18 0 C. At the end of the liming, the stock is washed with cold water for about 24 hours to remove as much of the lime as possible.

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The stock solution is then neutralized with acid ( HCl , H2SO4, H3PO4) and the gelatin is extracted with water in an identical manner to that in the acid process, except that the pH is kept at values between 5.0–6.5 (neutral extraction). Solubility: Practically insoluble in acetone, chloroform, ethanol (95%), ether, and methanol. Soluble in glycerin, acids, and alkalis, although strong acids or alkalis cause precipitation. In water, gelatin swells and softens, gradually absorbing between five and 10 times its own weight of water. Gelatin is soluble in water above 408C, forming a colloidal solution, which gels on cooling to 35–408C. This gel–sol system is thixotropic and heat reversible.

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5.Bentonite: Bentonite is a crystalline, claylike mineral, and is available as an odorless, pale buff, or cream to grayish-colored fine powder, which is free from grit. Bentonite is a native colloidal hydrated aluminum silicate consisting mainly of montmorillonite , Al2O34SiO2H2O; it may also contain calcium, magnesium, and iron. Bentonite as a natural clay containing a high proportion of montmorillonite , a native hydrated aluminum silicate in which some aluminum and silicon atoms may be replaced by other atoms such as magnesium and iron.

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Applications in Pharmaceutical Formulation Bentonite is used primarily in the formulation of suspensions, gels, and sols, for topical pharmaceutical applications. It is also used to suspend powders in aqueous preparations and to prepare cream bases containing oil-in-water emulsifying agents. In oral preparations, bentonite , and other similar silicate clays, can be used to adsorb cationic drugs and so retard their release. Adsorbents are also used to mask the taste of certain drugs.

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Bentonite has been investigated as a diagnostic agent for magnetic resonance imaging. Therapeutically, bentonite has been investigated as an adsorbent for lithium poisoning. Solubility: Practically insoluble in ethanol, fixed oils, glycerin, propan-2-ol, and water. Bentonite swells to about 12 times its original volume in water, to form viscous homogeneous suspensions, sols, or gels depending upon the concentration.

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Method of Manufacture: The mined ore is processed to remove grit and nonswelling materials so that it is suitable for pharmaceutical applications.

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6. Attapilgite : Attapulgite occurs as a light cream colored, very fine powder. Particle size ranges depend on the grade and manufacturer. Attapulgite is a purified native hydrated magnesium aluminum silicate consisting of the clay mineral palygorskite , with the empirical formula Mg(Al0.5–1Fe0–0.5)Si4O10(OH)4H2O. Method of Manufacture: Attapulgite occurs naturally as the mineral palygorskite .

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Applications in Pharmaceutical Formulation: Attapulgite is widely used as an adsorbent in solid dosage forms. Colloidal clays (such as attapulgite ) absorb considerable amounts of water to form gels and in concentrations of 2–5% w/v usually form oil-in-water emulsions. Activated attapulgite , which is attapulgite that has been carefully heated to increase its absorptive capacity, is used therapeutically as an adjunct in the management of diarrhea.

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Incompatibilities: Attapulgite may decrease the bioavailability of some drugs such as loperamide and riboflavin. Oxidation of hydrocortisone is increased in the presence of attapulgite .

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7.Methylcellulose: Methylcellulose occurs as a white, fibrous powder or granules. It is practically odorless and tasteless. Methylcellulose is a long-chain substituted cellulose in which approximately 27–32% of the hydroxyl groups are in the form of the methyl ether. The various grades of methylcellulose have degrees of polymerization in the range 50–1000, with molecular weights (number average) in the range 10 000–220 000 Da. The degree of substitution also affects the physical properties of methylcellulose, such as its solubility.

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Applications in Pharmaceutical Formulation: Methylcellulose is widely used in oral and topical pharmaceutical formulations. In tablet formulations, low- or medium-viscosity grades of methylcellulose are used as binding agents, the methylcellulose being added either as a dry powder or in solution. High viscosity grades of methylcellulose may also be incorporated in tablet formulations as a disintegrant . Methylcellulose may be added to a tablet formulation to produce sustained-release preparations. Tablet cores may also be spray-coated with either aqueous or organic solutions of highly substituted low-viscosity grades of methylcellulose to mask an unpleasant taste or to modify the release of a drug by controlling the physical nature of the granules.

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Low-viscosity grades of methylcellulose are used to emulsify olive, peanut, and mineral oils. They are also used as suspending or thickening agents for orally administered liquids. High-viscosity grades of methylcellulose are used to thicken topically applied products such as creams and gels. In ophthalmic preparations, a 0.5–1.0% w/v solution of a highly substituted, high-viscosity grade of methylcellulose has been used as a vehicle for eye drops. Therapeutically, methylcellulose is used as a bulk laxative; it has also been used to aid appetite control in the management of obesity

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Solubility: Practically insoluble in acetone, methanol, chloroform, ethanol (95%), ether, saturated salt solutions, toluene, and hot water. Soluble in glacial acetic acid and in a mixture of equal volumes of ethanol and chloroform. In cold water, methylcellulose swells and disperses slowly to form a clear to opalescent, viscous, colloidal dispersion. Method of Manufacture: Methylcellulose is prepared from wood pulp (cellulose) by treatment with alkali followed by methylation of the alkali cellulose with methyl chloride. The product is then purified and ground to powder form.

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8. Carboxymethylcellulose : Carboxymethylcellulose sodium occurs as a white to almost white, odorless, tasteless, granular powder. It is hygroscopic after drying. Carboxymethylcellulose sodium as the sodium salt of a polycarboxymethyl ether of cellulose. It is used as coating agent; stabilizing agent; suspending agent; tablet and capsule disintegrant ; tablet binder; viscosity-increasing agent; water-absorbing agent.

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Applications in Pharmaceutical Formulation: Carboxymethylcellulose sodium is widely used in oral and topical pharmaceutical formulations, primarily for its viscosity-increasing properties. Carboxymethylcellulose sodium may also be used as a tablet binder and disintegrant , and to stabilize emulsions. Higher concentrations, usually 3–6%, of the medium-viscosity grade are used to produce gels that can be used as the base for applications. Carboxymethylcellulose sodium is also used in self-adhesive ostomy , wound care, and dermatological patches as a muco -adhesive and to absorb wound exudate or transepidermal water and sweat.

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Solubility: Practically insoluble in acetone, ethanol (95%), ether, and toluene. Easily dispersed in water at all temperatures, forming clear, colloidal solutions. The aqueous solubility varies with the degree of substitution (DS). Method of Manufacture: Alkali cellulose is prepared by steeping cellulose obtained from wood pulp or cotton fibers in sodium hydroxide solution. The alkaline cellulose is then reacted with sodium monochloroacetate to produce carboxymethylcellulose sodium. Sodium chloride and sodium glycolate are obtained as by-products of this etherification.

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9. Cabopols : These are carboxyvinyl polymers of large molecular weight having acidic reaction and limited solubilities in water. Carbopol 934 is a free flowing acid polymer, which disperses readily in water to yield an adid solution of low viscocity . Carbopol 934 is inert and in non-sensitizer. Its thickness efficiency can be employed in the preparation of cream, ointments, lotions, suspension and emulsions. Grades of carbopol are carbopol 940 and 941. They differ in sensivities to ion, heat and shear. Soluble monovalent and polyvalent salts cause a decrease in viscosity of carbopol 934 macilage .

Ion exchange resins:

Ion exchange materials are insoluble substances containing loosely held ions which are able to be exchanged with other ions in solutions which come in contact with them. These exchanges take place without any physical alteration to the ion exchange material. Ion exchangers are insoluble acids or bases which have salts which are also insoluble, and this enables them to exchange either positively charged ions ( cation exchangers) or negatively charged ones (anion exchangers). Ion exchange resins

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Many natural substances such as proteins, cellulose, living cells and soil particles exhibit ion exchange properties which play an important role in study of chemicals. Resins consisting of polystyrene with sulphonate groups to form cation exchangers or amine groups to form anion exchangers were developed. Uses A bed of resin can be used either to remove unwanted ions from a solution passed through it or to accumulate a valuable mineral from the water which can later be recovered from the resin. Examples of the removal of unwanted ions are the removal of heavy metals from metal trade wastes, the demineralistion of the whey used to manufacture specialized dairy products and the removal of salts from fruit juices. Strong cation resins in the hydrogen form are used for the hydrolysis of starch and sucrose.

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Resins also find many uses in the laboratory where the chemist.s ingenuity is less constrained by economic considerations. They can be used to remove interfering ions during analysis or to accumulate trace quantities of ions from dilute solutions after which they can be concentrated into a small volume by elution. A cation resin in the hydrogen form can be used to determine the total concentration of ions in a mixture of salts. Water softening In water softening a cation resin in the sodium form is used to remove hard metal ions (calcium and magnesium) from the water along with traces of iron and manganese, which are also often present. These ions are replaced by an equivalent quantity of sodium, so that the total dissolved solids content of the water remains unchanged as does the pH and anionic content.

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Demineralisation : This requires complete removal of ions i.e. cations as well as anions. Water is passed through an acidic cation exchanger when metallic cations are exchanged with H + ions. This water obtained is then passed through a basic anion exchanger when the anions present in the water are exchanged by OH - of the exchanger . The H + and OH - ions which pass into the solution combine to form unionised water. Ion-exchange resins are used as excipients in pharmaceutical formulations such as tablets, capsules, and suspensions. In these uses the ion-exchange resin can have several different functions, including taste-masking, extended release, tablet disintegration, and improving the chemical stability of the active ingredients.

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There are four main types differing in their functional groups 1)strongly acidic sulfonic acid groups 2) strongly basic quaternary amino groups 3)weakly basic carboxylic acid groups 4)weakly acidic primary, secondary, and/or tertiary amino groups, e.g. polyethylene amine Amberlite ( Polacrilin potassium): Polacrilin potassium occurs as a cream-colored, odorless and tasteless, free-flowing powder. Aqueous dispersions have a bitter taste. Applications in Pharmaceutical Formulation: Polacrilin potassium is a cation -exchange resin used in oral pharmaceutical formulations as a tablet disintegrant . Concentrations of 2–10% w/w have been used for this purpose, although 2% w/w of polacrilin potassium is usually sufficient.

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Other polacrilin ion-exchange resins have been used as excipients to stabilize drugs, to mask or modify the taste of drugs, and in the preparation of sustained-release dosage forms and drug carriers. Polacrilin resins are also used in the analysis and manufacture of pharmaceuticals and food products. Solubility: Practically insoluble in water and most other liquids, although polacrilin resins swell rapidly when wetted. Incompatibilities: Incompatible with strong oxidizing agents, amines, particularly tertiary amines, and some other substances that interact with polacrilin resins.

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Method of Manufacture: Polacrilin resin ( Amberlite IRP-64) is prepared by the copolymerization of methacrylic acid with divinylbenzene (DVB). Polacrilin potassium ( Amberlite IRP-88) is then produced by neutralizing this resin with potassium hydroxide.

FILM COATING MATERIAL ::

A film coating material is a thin polymer-based coat applied to a solid dosage form such as a tablet, granule or other particle. The thickness of such a coating is usually between 20 and 100 μm . The vast majority of the polymers used in film coating are either cellulose derivatives such as the cellulose ethers, carboxymethylcellulose , methylcellulose, ethylcellulose etc. or acrylic polymers and copolymers such as vinyl- maleic acid. Occasionally high molecular weight polyethylene glycols, polyvinyl pyrrolidone , polyvinyl alcohol and waxy materials are used. FILM COATING MATERIAL :

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Solvents: are usually nonaqueous . Plasticizing agent: such as dimethyl phthalate or waxy material such as PEG, to impart flexibility to film. Colours : to impart colour to the tablet coating. Opacifying agents: increase the covering power of the film coat. Example: titanium dioxide, calcium sulphate Film coating is done by two methods: a) pan-pour methods:- tablets that are coated by pan-pour method always require additional drying step to remove latent solvents. b) pan spray methods. Disintegration time of film coated should not exceed to 2 hours.

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Various film coating materials are described as follows: 1.Sodiumcarboxymethylcellulose: Carboxymethylcellulose sodium occurs as a white to almost white, odorless, tasteless, granular powder. It is hygroscopic after drying. This material is a sodium salt of carboxymethylcellulose and is manufactured by the reaction of soda cellulose with the sodium salt of monochloroacetic acid. It is available in low, medium, high viscosity grades. It is easily dispersed in water to form colloidal solutions but it is insoluble in most organic solvents. Films prepared by it are brittle.

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2.Acrylate polymers: it is marketed under eudragit E is a cationic co-polymer based on dimethylamino methacrylate and other neutral methacrylate esters. It is freely soluble in gastric fluid up to PH 5. This material is available as organic solution(12.5%) in isopropanol /acetone, solid material, 30% aqueous dispersion. These polymers produce films for the delayed action. 3. polyethylene glycol: as being an addition polymer of ethylene oxide and water. Polyethylene glycol grades 200–600 are liquids; grades 1000 and above are solids at ambient temperatures. Liquid grades (PEG 200–600) occur as clear, colorless or slightly yellow-colored, viscous liquids. They have a slight but characteristic odor and a bitter, slightly burning taste.

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PEG 600 can occur as a solid at ambient temperatures. Solid grades (PEG>1000) are white or off-white in color, and range in consistency from pastes to waxy flakes. They have a faint, sweet odor. Grades of PEG 6000 and above are available as freeflowing milled powders. Combination of PEG with cellulose acetate phthalate provide films that are soluble in gastric fluid. Coats produced by it are hard, smooth, tasteless, non-toxic.

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Method of Manufacture Polyethylene glycol polymers are formed by the reaction of ethylene oxide and water under pressure in the presence of a catalyst.

Superdisintegrants:

Superdisintegrants are used in tablets and capsules to ensure that these comparts are rapidly broken down into the primary particles to facilitate the dissolution or release of the active ingredients. Superdisintegrants which provide improved compressibility and which does not negatively impact the compressibility of formulations which include high dose drugs Examples: Crospovidone L-HPC: (Low substituted hydroxy propyl cellulose) Sodium starch glycolate . Superdisintegrants

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On contact with water the superdisintegrants swell, hydrate, change volume or form and produce a disruptive change in the tablet.

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EXAMPLE SUPER-DISINTEGRANTS Crosslinked cellulose Crosscarmellose ® Ac -Di-Sol ® Primellose ® Vivasol ® Crosslinked PVP Crosspovidone Kollidon Polyplasdone Crosslinked starch Sodium Starch Glycolate Crosslinked alginic acid Alginic acid NF Satialgine Natural super Disintegrants Soy polysaccharides Emcosoy Calcium Silicate

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Modified celluloses Carboxymethylcellulose / Crosslinked cellulose and its derivative ( Croscarmellose Sodium) Cross-linked sodium carboxymethylcellulose is a white, free flowing powder with high absorption capacity. It has a high swelling capacity and thus provides rapid disintegration and drug dissolution at lower levels. It also has an outstanding water wicking capability and its cross-linked chemical structure creates an insoluble hydrophilic, highly absorbent material resulting in excellent swelling properties. Its recommended concentration is 0.5–2.0%, which can be used up to 5.0% L-HPC (Low substituted Hydroxy propyl cellulose). It is insoluble in water, swells rapidly and is used in the range of 1-5%. The grades LH- 11 and LH-21 exhibit the greatest degree of swelling.

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Cross-linked polyvinylpyrrolidone / Crosslinked PVP It is a completely water insoluble polymer. It rapidly disperses and swells in water but does not gel even after prolonged exposure. The rate of swelling is highest among all the superdisintegrants and is effective at 1-3%. It acts by wicking, swelling and possibly some deformation recovery. The polymer has a small particle size distribution that imparts a smooth mouth feel to dissolve quickly. Varieties of grades are available commercially as per their particle size in order to achieve a uniform dispersion for direct compression with the formulation.

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Modified starches / Crosslinked starch Sodium starch glycolate is the sodium salt of a carboxymethyl ether of starch. It is effective at a concentration of 2-8%. It can take up more than 20 times its weight in water and the resulting high swelling capacity combined with rapid uptake of water accounts for its high disintegration rate and efficiency. It is available in various grades i.e. Type A, B and C, which differ in pH, viscosity and sodium content. Other special grades are available which are prepared with different solvents and thus the product has a low moisture (<2%) and solvent content (<1%), thereby being useful for improving the stability of certain drugs.

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Cross-linked Alginic Acid It is insoluble in water and disintegrates by swelling or wicking action. It is a hydrophilic colloidal substance, which has high sorption capacity. It is also available as salts of sodium and potassium. Soy polysaccharide / Natural super Disintegrants It is a natural super disintegrant that does not contain any starch or sugar so can be used in nutritional products. Calcium Silicate It is a highly porous, lightweight superdisintegrant , which acts by wicking action. Its optimum concentration range is 20-40%

Directly compressible vehicles:

The method consist of compressing tablets directly from powdered material without modifying the physical natuer of the material. Tablets are compressed directly from powder blends of the active ingredient (such as chloride, chlorates, bromide, ammonium chloride etc) and suitable excipients . These substances posses cohesive and flow property that make direct compression posssible . No pretreatment of the powder blends like wet or dry granulation procedures is necessary. Direct compression eliminates variabilities of wet granulation processing binders (temp, viscous, quality) and other agents. Directly compressible vehicles

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Advantages are Elimination of granulation process Heat, Moisture (wet granulation); High pressure (dry granulation). Avoidance of high compaction pressures involves in producing tablets by slugging or roll compaction. Rate of binder addition and kneading can affect the properties of the granules formed The granulating solution, the type and length of mixing and the method and rate of wet and dry screening can change the density and particle size of the granules, which can have a major effect on fill weight and compaction qualities Type and rate of drying can lead not only to critical changes in equilibrium MC but also to unblending as soluble active ingredients migrate to the surfaces of the drying granules More unit processes are incorporated in production, the chances of batch-to-batch variation are compounded

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Direct compression fillers: Common materials that have been modified in the chemical manufacturing process to improve fluidity and compressibility are as follows: Spray dried lactose, 95.8% sucrose, 3% modified dextrin, crystalline lactose, crystalline Sorbitol , Mannitol etc. Tablet compression machine: 1)Hopper for holding and feeding granulation to be compressed. 2) Dies that define the size and shape of the tablet. 3) Punches for compressing the granulation within the dies. 4) Cam tracks for guiding the movement of the punches. 5) Feeding mechanisms for moving granulation from the hopper into the dies.

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Compression process Filling: By gravitational flow of powder from hopper via the die table into die. The die is closed at its lower end by the lower punch. The upper punch descends and enters the die and the powder is compressed until a tablet is formed. During the compression phase, the lower punch can be stationary or can move upwards in the die to eject tablet. After maximum applied force is reached, the upper punch hammers on powder to form tablet. After this phase, the lower punch rises until its tip reaches the level of the top of the die. The tablet is subsequently removed from the die and die table by a pushing device or knife.

Surfactants :

Surfactants are compounds that lower the surface tension of a liquid, the interfacial tension between two liquids, or that between a liquid and a solid. Surfactants may act as detergents, wetting agents, emulsifiers, foaming agents, and dispersants. Surfactants are usually organic compounds that are amphiphilic , i.e. they contain both hydrophobic groups (their tails ) and hydrophilic groups (their heads ). Therefore, a surfactant contains both a water insoluble (or oil soluble) component and a water soluble component. Surfactants will diffuse in water and adsorb at interfaces between air and water or at the interface between oil and water, in the case where water is mixed with oil. Surfactants

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The insoluble hydrophobic group may extend out of the bulk water phase, into the air or into the oil phase, while the water soluble head group remains in the water phase. This alignment of surfactants at the surface modifies the surface properties of water at the water/air or water/oil interface. Classification of surfactants: The "tail" of most surfactants consisting of a hydrocarbon chain, which can be branch, linear, or aromatic. Fluorosurfactants surfactants have fluorocarbon chains. Siloxane surfactants have siloxane chains.

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1.Anionic surfactants: It contains anionic functional groups at their head, such as sulfate, sulfonate , phosphate, and carboxylates . Anionic surfactants containing sulfate, sulfonate , and carboxylates ion are known as soaps. The chain length of fatty acid ranges from 12 to 18 without which the polar part becomes weak. Monovalent soaps are hydrophillic in nature whereas di - and trivalent soaps are hydrophobic because of higher proportion of hydrophobic moiety. Alkyl sulfates include ammonium lauryl sulfate, sodium lauryl sulfate (SDS, sodium dodecyl sulfate), carboxylate includes sodium stearate .

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2.Cationic surfactant: These are chiefly quaternary ammonium compounds. They are mostly used for antimicrobial activity. Ex:- cetyl trimethylammonium bromide (CTAB), hexadecyl trimethyl ammonium bromide, cetyl trimethylammonium chloride (CTAC), Cetylpyridinium chloride (CPC), Benzalkonium chloride (BAC) Benzethonium chloride (BZT). Another group of cationic surfactants comprises of amine salts. They act as surfactants and posses good wetting, foaming and detergent properties. Ex:- octodecylamine hydrochloride.

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3.Non-ionic surfactants: These are widely used due to compatibility, stablilty and low toxicity. They may be: water insoluble:- are the long chain fatty acids. Ex: laury , cetyl and stearyl alcohol, propylene glycol etc. Water soluble:- it contains polyoxyethylene groups added through an ether linkage with one of their alcohol group. Ex:- polyoxyethlene sorbitan fatty acid ester. 4. Zwitterionic surfactants: Zwitterionic ( amphoteric ) surfactants have both cationic and anionic centers attached to the same molecule. The cationic part is based on primary, secondary, or tertiary amines or quaternary ammonium cations . The anionic part can be more variable. Ex:- N- dodecyl -N,N- dimethlbetain ( zwitter ion).

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Micelle formation: surfactants are helpful in the solubilization of poorly water soluble molecules through the formation of micelle. When a surfactant is dissolved in water in very low concentration, a fraction of it will be absorbed at the air-water interface whereas the remainder will residue in the bulk. When more surfactant is added the interface becomes fully saturated and the surfactant is forced into the bulk of liquid and surfactants form aggregates, such as micelles , where the hydrophobic tails form the core of the aggregate and the hydrophilic heads are in contact with the surrounding liquid.

Other types of aggregates such as spherical or cylindrical micelles or bilayers can be formed. The shape of the aggregates depends on the chemical structure of the surfactants :

Other types of aggregates such as spherical or cylindrical micelles or bilayers can be formed. The shape of the aggregates depends on the chemical structure of the surfactants

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HLB scale: HLB is a means of expressing the hydrophilic property of surfactants in figures The functional utility of surfactant depends on the hydrophillic and lipophillic group attached to it. An arbitary scale was devised by Griffin to serve as a measure of the HLB of surfactants.

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The values of surfactants are: 0-3= antifoaming agents 3-8= w/o emulsifying agent 7-9= wetting and spreading agent 8-16= o/w emulsifying agent 13-16= detergents Above 16= solubilizing agent Pharmaceutical applications of surfactants: 1.Wetting agents 2.Emulsifying agent 3.Solubilizing agent 4.Foaming and antifoaming agent

Standardization of excipients :

NEED:- After invention of any new component to be used as an Excipient . To verify the particular use of an Excipient . To establish the standards for newly invented Excipient . STANDARDIZATION OF EXCIPIENTS: IPEC (International Pharmaceutical Excipient Council)Significant Change Guidance: Two areas of concern to excipient makers and users have been those of significant change and certificates of analyses. Any change by the manufacturer of an excipient that alters excipient’s physical or chemical property from the norm or that is likely to alter the excipient’s performance in dosage form is considered significant. Standardization of excipients

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The types of changes that might be considered include: Site Scale Equipment Process Packaging Specifications. 1.EVALUATION CRITERIA:- The evaluation criteria in the guideline include: Changes in the chemical properties of excipients owing to the change in the physical properties of excipients . Changes in the impurity profile of excipients . Changes in the functionality of excipients . Changes in the moisture level of excipients . Changes in the bioburden of excipients . 2. IMPURITY PROFILE:- The IPEA-Americas profile addresses the following guide:- All specific organic impurities should not exceed to 0.1% of total weight.

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3.PRECLINICAL TESTING OF EXIPIENTS: Essentially, a new (novel) excipient is a material that has not been previously used in a pharmaceutical formulation. New proposed excipients cover a range of functions from conventional use to active roles of enhanced drug uptake and specific drug delivery. The older formulations with compatible excipients are compared with the newer formulation of same active ingredients using new excipients . GUIDELINES: A possible approach in toxicity studies is to add groups of animals that receive the excipient alone as well as the drug- excipient groups. The testing strategies proposed by IPEC and the FDA offer a useful starting point for preclinical excipient testing.

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Proposed study types are given for a range of dose routes, including oral, topical, parenteral and inhalational. The FDA has divided testing requirements into those needed to support maximum clinical duration of up to 14 consecutive days (short-term use), more than two weeks but three months or less (intermediate use), and more than three months of use (long-term use). Additional considerations: For inhalation/intranasal route: acute inhalation toxicity, application site, and pulmonary sensitization studies. For parenteral route: acute parenteral toxicity and application site studies. For mucosal use: application site evaluation. For transdermal and topical drugs: application site and photo toxicity/ photoallergy evaluation.

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ARRANGEMENT DURING STANDERDIZATION:- Although it was originally intended that each monograph contain only information about a single excipient , it rapidly became clear that some substances or groups of substances should be discussed together. This gave rise to such monographs as ‘Coloring Agents’ and ‘Hydrocarbons’. In addition, some materials have more than one monograph depending on the physical characteristics of the material, e.g. Starch versus Pregelatinized Starch. Regardless of the complexity of the monograph they are all divided into 22 sections as follows: 1.Nonproprietary Names: Lists the excipient names used in the current British Pharmacopoeia, European Pharmacopeia, Japanese Pharmacopeia, Indian Pharmacopoeia and the United States Pharmacopeia/National Formulary.

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2.Synonyms: Lists of other names for the excipient , including trade names used by suppliers (shown in italics). 3.Chemical Name and CAS Registry Number: the unique Chemical Abstract Services number for an excipient along with the chemical name. 4.Empirical Formula and Molecular Weight: shows emperical and molecular weight. 5.Structural Formula: shows sructural formula. 6.Functional Category:Lists the function(s) that an excipient is generally thought to perform, e.g., diluent , emulsifying agent, etc. 7.Applications in Pharmaceutical Formulation or Technology: indicates the appilcation of excipient in various formulations.

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8. Description: Includes details of the physical appearance of the excipient , e.g., white or yellow flakes, etc. 9. Pharmacopeial Specifications: presents the compendial standards for the excipient . Information included is obtained from BP, USP, IP, PhEup , JP,etc 10.Typical Properties: Describes the physical properties of the excipient which are not shown in Section 9. All data are for measurements made at 20°C unless otherwise indicated. Where the solubility of the excipient is described in words. 11. Stability and Storage Conditions: Describes the conditions under which the bulk material as received from the supplier should be stored. In addition some monographs report on storage and stability of the dosage forms that contain the excipient .

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12.Incompatibilities: Describes the reported incompatibilities for the excipient either with other excipients or with active ingredients. 13.Method of Manufacture: Describes the common methods of manufacture and additional processes that are used to give the excipient its physical characteristics. 14.Safety: Describes briefly the types of formulations in which the excipient has been used and presents relevant data concerning possible hazards and adverse reactions that have been reported. 15.Handling Precautions: Indicates possible hazards associated with handling the excipient and makes recommendations for suitable containment and protection methods.

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16.Regulatory Status: Describes the accepted uses in foods and licensed pharmaceuticals where known. 17.Related Substances: Lists excipients similar to the excipient discussed in the monograph. 18.Comments: Includes additional information and observations relevant to the excipient . Where appropriate, the different grades of the excipient available are discussed. 19.Specific References: list of references cited within the monograph. 20.General References: Lists references which have general information about this type of excipient or the types of dosage forms made with these excipients . 21.Authors: Lists the current authors of the monograph in alphabetical order 22.Date of Revision: Indicates the date on which changes were last made to the text of the monograph.

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References: A text book of professional pharmacy by Jain and Sharma. The theory and practices of Industrial pharmacy Leon Lachman . Text book of physical pharmaceutics by C.V.S. Subramanyam .

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