SUPPOSITORY ppt by chirag patel

Category: Education

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Slide 2:

Definition :- “suppositories are solid dosage form meant to be inserted into body cavity like rectum, urethra, vagina where they melt or soften to release the drugs & exert local or systemic effect.” Shapes available : cone, bullet, torpedo

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Advantages :- Alternate dosage form for the drugs with less bioavailability when taken orally. Drugs having bad odour & taste. For treating unconscious & vomiting patients Suitable for administration of drugs which cause gastric irritation For infants & old people who find difficulty in swallowing Administration of drugs which are destroyed by portal circulation Site- specific action on rectal, urethra, etc….

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Disadvantages :- Not much acceptable by patient Manufacturing process is difficult Drug which cause irritation to mucous membrane can’t be administered Maintenance of temperature is difficult Leakage of suppository occurs upon insertion into the body cavity at elevated temperature.

Properties of an ideal suppository base :- :

Properties of an ideal suppository base :- Should melt at body temperature or dissolve or disperse in body temperature. Should release any medicament and be compatible with. Should keep it’s shape during handling. Should be non-toxic and non-irritant . Should be stable on storage. Should be easily molded and should not adhere to the mold. Should be stable if heated above its melting point. Should have good emulsifying & wetting properties. Acid value : <0.2 or zero. ; iodine value : <7 ; Saponification value : 200 – 245.

Formulation :-:

Formulation :- Formulation includes ; Suppository bases. Active ingredients. Additives.

Bases :-:

Bases :- Lipophilic bases (fatty bases) : These melt at body temperature. Ex. : cocoa butter (Theobromaoil), synthetic base. Hydrophilic base : Dissolves or disperse in rectal separation. Ex. : glycerogelatin, macrogols(PEG), tween & span.

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1. Cocoa butter(theobromo oil) :- Properties:- Natural triglyceride. It exhibits polymorphism. Yellowish-white solid with a chocolate like odour. It is a mixture of glyceryl ester of stearic , palmetic,oleic acid & other fatty acid. Advantages:- Disadvantages:-

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2 . synthetic fats:- Properties:- Prepared by esterification or hydrogenation of vegetable oils. The first useful product come from the hydrogenation & subsequent heat treatment of vegetable oil such as palm kernal & arachis . Advantages:- Disadvantages:- 3.surfactant:- Ex. – tween , span. Property:- Mixture of non-ionic surfactants which are chemically related to PEG. They are used alone or in combination with other base. Advantages:- Disadvantages:-

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4.Glycerogelatin base:- Properties:- Mixture of glycerin and water made in to a stiff jelly by adding gelatin. According to BP composition of base is, Gelatin –- 14% ,glycerol—70% According to USP ,gelatin—20%,glycerol—70% Gelatin is colorless or pale yellow & available in translucent sheets, granules or powder. Advantages:- Disadvantages:-

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5.Polyethylene glycols(macrogols) properties:- Long chain polymer of ethylene oxide. They occur as solid and liquid. Liquid have molecular weight ranging from 200-600. Solid have molecular weight more then 1000. Mixture of two or more grades of microgols used as suppository base. Advantages:- Disadvantages:-

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Preparation of suppository:- Molds:- Metal device used to get the required shape. Made up of aluminum , brass, stainless steel, or plastics. Calibration of mold:- It is the adjustment of mold to get suppositories of uniform weight, even though different base are used. It is done prier to suppositories. A set of suppositories are prepared using only the base. The average weight of them is calculated & it is taken as the true weight of suppositories prepared using that mold , which is the capacity of mold.

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Displacement value:- The volume of suppository from particular mold is uniform but its weight will vary because the density of medicament usually differ from the density of base . To prepare product accurately , allowance must be made for the change in density of mass due to added medicament The most convenient way of making this allowance is to use the displacement value-“ the number of part by the weight of medicament that displace the one part by weight of base”

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Methods of preparation:- Hand molding Automatic machine molding Compression molding Heat molding Hand molding:- The rolling tile is lubricated with starch or talcum powder in order to prevent the adherence of mass. Procedure :- Advantages:- Suitable for thermo labile ingredients. Economical for the manufacture of small number of suppositories. Disadvantages:- No uniformity in shape & size of suppository. -

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Automatic machine molding:- It performs automatically all the operation-mold filling , solidification & removal of suppository. Two type of machine: Rotary machine (3500-6000 suppositories per hour) Linear machine (up to 10,000 suppositories per hour) Procedure :- Advantages:- The rate of production is high No chance of air entrapment & contamination of suppository. Disadvantage:- If any mass deposited in the mold is not removed during cleaning, it result in incomplete closure of molds and produce suppositories of over weight.

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Compression molding:- It consist of cylinder, piston, molds, metallic stop plate at the bottom. Procedure :- Advantages:- Suitable for thermo labile drugs. No possibility of settling of the insoluble solids in base. Disadvantages:- Rate of production is low so not suitable for large scale. Air get entrapped in the mass which leads to oxidation of ingredients.

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Heat molding:- method involve following steps. Melting the base. Incorporation of drug. Filling of molds. Cooling & collection of suppositories. Incorporation of drug: Solid:-drug and additive powder mixed on warm tile Semisolid:-triturate the ingredients on warm tile with water. this decrease the viscosity and give homogenous liquid. Liquid:- Volatile liquid:-they can be added to the molten base directly. Nonvolatile liquid:- same as semisolid.

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Packing of suppositories:- It can be foiled in aluminum ,plastic, paper, tin strip. Modern packing machine: nearly 8000 suppositories can be wrapped per hour. In packing molding : In this ,the suppository mass is directly move into the series of molds which are made up of plastic. After cooling , excess mass is trimmed of . By this technique 12,000 to 15,000 suppositories can be produce per hour. Disposable molds:- They are suitable for tropical climate. They are made up of plastic or aluminum . Labeling:- “store in a cool place.” “Not to be taken orally.”

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Evaluation of suppositories:- Appearance Uniformity of weight Disintegration Test for uniformity of drug content Breaking test Softening time Test of melting rang Test for Dissolution rate

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Stability study of suppository:- Storage :- protected from heat ,preferably by storing in refrigerator. Stability problem:- Active ingrediants and base must be stable at refrigerator temp. as well as room temp. storage condition for at least 2 year. Storage stability study are normally conducted at 4 °c and at room temp.(25 ± 3 °c). The suppository over wrap foil can also be damaged. Ex. If suppository contain an acid ,the foil wrapping may be attacked and develop e pin hole. The softening time test and differential scanning colorimetry cam be used as stability indicating test methods.

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Recent development(new trend in suppository) Capsule suppositories Coated suppositories Layer suppositories Tablet suppositories; Compressed tablet Effervescent base tablet

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Thanking you - Chirag J. Patel

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