sterile dosage forms


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STERILE DOSAGE FORMS Presented By : Mr. Naresh Rajgor, Assistant Professor, M.P. Patel College of Pharmacy, Kapadwanj


DEFINITION Sterile products are dosage forms of therapeutic agents that are free of viable microorganism. These includes parenteral, ophthalmic and irrigating preparation. Sterile products are more frequently solutions or suspensions, but may even be solid pellets for tissue implantation.


Advantages Quick onset of action Suitable for the drugs which are not administered by oral route Useful for unconscious or vomiting patients. Duration of action can be prolonged by modifying formulation. Suitable for nutritive like glucose & electrolyte. Suitable for the drugs which are inactivated in GIT or HCl (GI fluid)


Disadvantages Once injected cannot be controlled (retreat) Injections may cause pain at the site of injection Only trained person is required If given by wrong route, difficult to control adverse effect Difficult to save patient if overdose Sensitivity or allergic reaction at the site of injection Requires strict control of sterility & non pyrogenicity than other formulation.

Ideal Requirements:

Ideal Requirements Sterility (must) Pyrogen (must) Free from particulate matter (must) Clarity (must) Stability (must) Isotonicity Solvents or vehicles used must meet special purity and other standards. Restrictions on buffers, stabilizers, antimicrobial preservative. Do not use coloring agents. Must be prepared under aseptic conditions. Specific and high quality packaging.

Formulation of sterile dosage form:

Formulation of sterile dosage form Sterile dosage forms are formulated as solutions, suspension, emulsion, liposomes, microspheres, nano systems and powders to be reconstituted as solution. Solvent system suitable for sterile products are limited to those that produce little or no tissue irritation, water is the most common. All components must be pure.

Formulation of sterile dosage forms/ Product Development:

Formulation of sterile dosage forms/ Product Development Sr. No Name of the agent 1 Vehicles Water Water Miscible vehicles Non aqueous vehicles 2 Excipient/solutes 2.A Antimicrobial Preservatives Benzyl alcohol Bezethonium chloride Butyl Paraben Chlorobutanol Metacresol Methylparaben Phenol Phenylmercuric citrate Propyl paraben Thimersol

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2.b. Solubilizers , wetting agents or emulsifiers Dimethylacetamide Dioctyl sodium sulfosuccinate Egg yolk phospholipid Ethyl alcohol Ethyl lactate, Glycerin, Lecithin, PEG40 castor oil PEG 300 Polysorbate 20,40, 80 Povidone , propylene glycol 2.C Buffers Acetic acid, adipic acid, Benzoic acid and sodium benzoate Citric acid, ;lactic acid, maleic acid, potassium phosphate, sodium actate , sodium citrate and tartrate , tartaric acid 2.D Bulking agents or tonicity modifiers Glycerin, lactose, mannitol , dextrose, NaCl , sodium sulfate, sorbitol


2.E Suspending Agents Helatin , methyl cellulose, pectin, PEG 4000, Na CMC, Sorbitol solution 2.F Chelating Agents EDTA disodium, Edetate calcium disodium, EDTA tetrasodium 2.G Local Anaesthetics Procaine HCl , Benzyl alcohol 2.H Stabilizers Creatinine , glycine , naicinamide , sodium acetyltryptophanate , sodium caprylate , sodium saccharine 2.I Antioxidants Ascorbic acid Sodium bisulfate Sodium metabisulfate , thiourea , BHT, Tocopherol


CONTAINERS AND CLOSURES A. GLASS CONTAINER Glass is the choice of container for most of SVP. It is composed of silicon dioxide, with varying amounts of other oxides such as sodium, potassium, calcium, magnesium, aluminium, boron and iron. The basic structural network of glass is formed by silicon oxide tetrahedron.

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Boric oxide will enter into this structure, but most of the other oxides do bot. The latter are only loosely bound and relatively free to migrate. These migratory oxides may leached into a solution in contact with the glass. The oxides thus dissolved may hydrolysed to raise pH of the solution and catalyse or enter into reaction. Such occurrences can be minimize by proper selection of glass composition.

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TYPES: Type I : A borosilicate glass Type II: a soda lime treated glass Type III: a soda lime glass NP: General Purpose soda lime glass, not for parenteral. Type I glass is composed of silicon dioxide (81%) and boric oxide (13%) with low level of non-network forming oxides. While Type II and type III glass compounds are composed of relatively high proportion of sodium oxide (14%) and calcium oxide (8%).

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B. PLASTIC COTAINERS Principle ingredient of plastic containers are thermoplastic polymers like polyethylene, polypropylene, PVC, polycarbonate, polyamide, polystyrene, teflon. Plastic materials used in the medical field have less other additives. In certain cases, some amount of plasticizer, fillers, antistatic agents, antioxidents and other ingredients may be added.

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Most of the plastic containers melt at elevated temperatures except polyethylene and polystyrene. Plastic materials used mainly because they are light weight, no breakable and with low additives have low toxicity and low reactivity with products. Reactivity can be occur with sorption of the polymer in some cases. Additive leached and may react with the products.

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Most polymers are adversely affected by elevated temperatures required for thermal sterilization and have a relatively high permeability for water vapor. Significant permeation of gases like oxygen may occur with some plastic containers.

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C. Rubber closures: Rubber closures are used to seal the openings of cartridges, vials and bottles and permeate and withdrawal of needle without loss of integrity of the sealed containers. Rubber closures are compounded of several ingredients like natural rubber or synthetic polymers usually sulfur and 2 mercaptobenzothiazole. Closure should be completely nonrective with the products.

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Testing: The physicochemical tests on aquous extracts includes pH, turbidity, residue on drying, iodine number and heavy metal content. The biological tests on saline, polyethylene glycol 400 and cottonseed oil extracts includes acute and chronic toxicity on mice and rabbits.

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