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Presentation Methods of preparation of suppositories .pptx
- 1. Methods of preparation of suppositories PREPARED BY: ABDULMALIK D22E71 SUBMITTED TO: DR. MISBAH SULTANA
- 2. Suppositories can be prepared by one of Four methods: (a) Hand rolling and shaping (b) Compression ( cold compression) (c) Molding from melt( fusion method) (d) Automated filling method
- 3. 1.Hand rolling and shaping Rolling is the oldest and simplest method of suppository preparation Steps involved in this method are: 1. A plastic-like mass is prepared by triturating grated base( e.g. Cocoa butter etc) and active ingredients in a mortar. 2. The mass is formed into a ball in the palm of the hands and immediately placed on a pill tile. 3. The kneaded mass is rolled between fingers into rode shaped units. 4. The rodes are cut into pieces then One end is pointed with the help of spatula.
- 6. ADVANTAGE There is no need to heat the base I.e cocoa butter Cocoa butter temperature should not be taken higher than 86-90F. If this happens, you will have to re-temper. Tempering is a type of heat treatment used to increase the toughness or recovery of crystalline form.
- 7. LIMITATION This method is used when only a few suppositories are to be prepared. 1. Effective hand rolling requires considerable practice and skill as well
- 8. 2.Compression molding (cold compressin method) Compression Molding is a method of preparing suppositories from a mixed mass of grated suppository base and medicaments which is forced into a special compression mold. This method follows the same procedure as that of hand molding except the base containg the drug is compressed into suppositories Using machine.
- 9. A BASIC REQUIREMENT The method requires that the capacity of the molds first be determined by compressing a small amount of the base into the dies and weighing the finished suppositories. When active ingredients are added, it is necessary to omit a portion of the suppository base, based on the density factors of the active ingredients
- 10. Steps 1. the suppository mass is placed in a cylinder 2. the cylinder is closed; pressure is applied from one end by Turning a wheel 3. the mass is forced out of the other end into the mold. 4. When the die is fi lled with the mass, a movable end plate at the back of the die is removed, 5. And when additional pressure is applied to the mass in the cylinder, so that the formed suppositories are ejected
- 13. Advantages It is a simple method skipping the task of hand rolling Suppositories formed are more elegant than hand rolled one. Avoids the sedimentation of insoluble solids in suppository base Compression is especially suited for making suppositories that contain heat-labile medicinal substances Disadvantages Entrap if air may occur causing • Weight variation • oxidation of base or drug used
- 14. 3.MOLDING FROM MELT MOLDING FROM MELT Fusion Molding involves first melting the suppository base, and then dispersing or dissolving the drug in the melted base. The mixture is removed from the heat and poured into a suppository mold. When the mixture has congealed, the suppositories are removed from the mold.
- 16. MOLDS Molds in common use today are made from 1.stainless steel, 2. aluminum, 3.brass, or 4.plastic.
- 19. They’re reusable and disposable. Commercially available molds available for preparation of rectal, vaginal, and urethral suppositories can produce individual or large numbers of suppositories of various shapes and sizes.
- 20. The fusion method can be used with all types of suppositories Suppositories are generally made from solid ingredients and drugs which are measured by weight. When they are mixed, melted, and poured into suppository mold cavities, they occupy a volume – the volume of the mold cavity WEIGHT/VOLUME= DENSITY Since the components are measured by weight but compounded by volume, density calculations and mold calibrations are required to provide accurate doses.
- 21. CONCEPT OF DENSITY FACTOR When a drug is placed in a suppository base, it will displace an amount of base as a function of its density. If the drug has the same density as the base, it will displace an equivalent weight of the base If the density of the drug is greater than that of the base, it will displace a proportionally smaller weight of the base. It is density factor ...which determine how much of base is displaced by drug.
- 22. For example, aspirin has a density factor in cocoa butter of 1.3 (see Remington’s). TO CALCULATE AMOUNT OF Base being REPLACEDWE CAN APPLY SIMPLE FORMULA…..number of grams of drug being added / density factor If a suppository is to contain 0.3 g of aspirin ( DRUG BEING ADDDED) , it will replace 0.3 g ÷ 1.3 or 0.23 g of cocoa butter. If the blank suppository (suppository without the drug) weighed 2 g, then 2 g – 0.23 g or 1.77 g of cocoa butter will be needed for each suppository, and the suppository will weigh 1.77 g + 0.3 g = 2.07 g.
- 23. Some example density factors of drugs in cocoa butter are shown in the table below (see Remington’s) Aspirin1.3 Bismuth salicylate4.5 Chloral hydrate1.3
- 24. COMMERCIAL SUPPOSITORY PRODUCTION 4.Automated filling of molds by volumetric dosing pumps Strips of perforated shells pass beneath dosing pumps & filled successively Passed through cooling chambers for solidification…..sealed and then packaged Quality control procedures i.e. weight, volume, leakage are conducted Advantages Product efficiency is inceased( hundreds or thousands of suppositories can be prepared at a time ) Least or no chances of contamination Low cost
- 26. References Ansel drug delivery system Remington’s PharmaLabs.Com Pictures are collected from Google scholar