Suppository: A suppository is a medicated solid dosage form which is meant to be used in the body cavities.

These are commonly used rectally, vaginally, and occasionally urethrally. PRINCIPLE: In the body cavities this soften melt dissolve, and exert localized or systemic effect. HISTORY: A suppository is not a modern invention. It was used since a few hundreds of years and was well known to the Egyptians and other ancient races of people. Ancient people used to employ a small wooden piece which was blunted so that it could be inserted into the rectum. They used to dissolve the drug in honey or in some such viscous liquid, dip the wooden piece in the viscous liquid and they used to insert it in the rectum and remove it after usage. Gradually bases or vehicles for carrying the drugs used in the rectum were discovered and the most prominent among them is Cocoa butter or Theobroma oil. Tests for suppositories: 1. General appearance 2. weight variation 3. Content uniformity 4. Assay of avtive ingredients 5. Disintegration test 6. liquification or dissolution test 7. Melting point determination 8. Breaking 1. GENRAL APPEARANCE: They should be of uniform shape & size when cut longitudinally the external an internal surface should be same 2. WEIGHT VARIATION TEST • Select 20 suppositories, weigh them and determine average weight • No suppository should deviate more than ± 5% of average weight, except 2 that may deviate but not more than ±7.5% 3. CONTENT UNIFORMITY TEST • Select a representative sample of 30 suppositories • Assay 10 of these as specified in monograph • Requirement are met if not more than 1 of these is outside ±15%of average value and none is outside ±25% • If 2 or 3 are individual values are outside the limit of ±15% of average value and none of these outside ±25% of average value • Repeat the procedure by using another 20 suppositories • Out of 30 not more than 3 should be outside ±15% and none is outside ±25% and test is passed. 4. ASSAY OF ACTIVE INGREDIANT • Perform the assay for active ingredients as specified in official monograph e.g. glycerogelatin • Dissolve no of suppositories equivalent of 8 gram of glycerol in 50 ml of water and add q.s. water to 250ml

MELTING TEST This is also called as macromelting range test.25ml of bromocresol purple solution and 0. each of 4mm in diameter. Repeat the same operation with 2 more suppositories 5. Any matter left b/w plates is completely melted and has no longer a solid core 4.1M NaOH to the same blue color. The dishes are repeated by a distance of 30mm • The perforated holes are arranged annulary in rings consisting of 6.Take 5ml of this solution and add 150 ml of water and o.1M NaOH to neutralize the blue colour of indicator • Add 1.00921g of glycerol. 60mm high. It has completely dissolve except for insoluble powder 2.6g of sodium metaphenodrate and allow standing for 15 minutes and titrating with 0. DISINTEGRATION TEST APPARATUS: • A cylinder of glass or other transparent material. LIQUIFICATION TEST This test measures the liquification time of the rectal suppositories in vivo condition . • Each ml of 0. The disintegrated product collect on the surface ( fatty substances) and sink to the bottom (insoluble powder or dissolved) 3. all these suppositories should disintegrate within 30 min unless otherwise specified LIMIT: • • Fat based suppositories not more than 30min Water soluble suppositories not more than 60min • 6. 5.1M NaOH is equivalent to 0.12& 20 holes about central hole • A water bath of atleast of 4liter capacity maintaining a temperature 33-38Ċ fitted with 2 stirrer PROCEDURE • • • Place a suppository on the lower perforated plate Insert the cylinder into water bath & operate for 30 min or specified in monograph The suppository is considered disintegrated if 1.12& 20 holes about central hole • in rings consisting of 6. 52mm in internal diameter • 2 stainless metal dishes containing 39 holes.It is measures of the time taken for entire suppositories to melt when immerse in a constant temperature water bath (37Ċ) The apparatus used in this test is completely immersed in a constant water bath and time taken for entire suppository to melt is measured 7.

Sponification test 2. paperboard boxes • Preferably hygroscopic products such as glycerogelatin and emulsified suppositories should be supplied in well closed glss or plastic container LABELLING `Store in cool place` is necessary & the warning `not to be taken` or `For rectal use only` is adviseable . rigid. production & shipping OTHER TSET 1. water no.APPARATUS: It consist of celofine tube tight at both ends of a condenser. Water at 37Ċ is circulated through the condenser. Iodine value 3. 4. at which suppository collapse is the breaking point • The force break the suppository should be sufficient to withstand handling. BREAKING TEST This test is designed to measure friability or brittlness of suppository APPARATUS: • It consist of double water chamber through which water is circulated at 37Ċ • A disc on which a suppository is placed which is connected with a rod linked with weight to be applied • At first 600g of weight is applied on the upper plate at 1min interval 200g weight is added • The wt. The time for the suppository to melt is monitored 9. Acid value PACKAGING • Extemporaneously prepared suppositories are usually packed in shallow. partitioned. Rancidity 5.when water temperature is stabilized at 37Ċ the suppository is dropped into it .

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