evaluation of Suppositories ppt..pptx

evaluating methods for suppositories

1. suppositories NAME- Rudradeep hazra First year first semester Roll-57 section -b session=2018-19 BENGAL SCHOOL OF TECHNOLOGY

2. Suppositories Evaluation of Suppositories

3. What are suppositories ? They are solid dosage form of medicament for insertion into body cavities other than mouth.they may be inserted into rectum,vagina or nasal cavity.The medicament is incorporated into the suppository base and the product is formulated in such a way that they will either melt or dissolve in the body cavity fluid to release the medicament .

4. Types of suppositories. So, the types are…. Rectal Suppositories -these are meant for introduction into rectum for their Systemic effect. Vaginal Suppositories -these are meant or introduction into the vagina. Nasal Suppositories -these are meant for intoduction into nasal cavities and are also known as nasal bougies . Urethral Suppositories -these are meant for introduction into the urethra and are also known as urethral bougies . Ear cones -these are meant for introduction into the ear and are also known as aurinaria .

5. New trends of suppositories. Tablet suppositories . Layered suppositories. Capsule suppositories. Coated suppositories. Disposable moulds.

6. Evaluation of suppositories

7. Various ways by which suppositories are secured: Appropriate test methods and specifications are developed, which are capable of guaranteeing that the purpose for which suppositories are used will be fulfilled.

8. TESTS FOR SUPPOSITORIES ARE: Uniformity of weight. Disintegration test. Content uniformity test. Melting point determination test . General appearance test. Assay of active contents. Liquefaction or Softening Time Tests of Rectal Suppositories. Breaking test . Dissolution test.

9. UNIFORMITY OF WEIGHT: Weigh 20 suppositories individually. Determine  their average weight. Not more than two of individual weights should deviate from the average weight more than 5% and none deviates by more than 10%.

10. DISINTEGRATION TEST: APPARATUS:  A transparent sleeve of glass or suitable plastic of height 60mm with an internal diameter of 52mm. A metal device consisting of two stainless discs each of which contain 39 holes, each 4mm in diameter. Diameter of the  disc  is closely similar to the internal diameter of the sleeve. Discs are separated by a distance of 30mm. Metal device is attached to outer sleeve by means of three equally spaced hooks.

11. Method:  Place a suppository on the lower perforated disc of metal device and then insert the device into the cylinder and attach this to the sleeve. Repeat the same operation with further two suppositories, metal device and sleeve. Place each piece of apparatus in a vessel containing at least five liters of water at 37C fitted with a slow stirrer and by holding the top of apparatus 90 mm below the surface of water. Disintegration is complete when molded suppositories are: Completely dissolved. Dispersed into its components. Have become soft. Disintegration occurs in not more than 30 minutes for fat based suppositories and for water-soluble suppositories disintegration occurs in not more than 60 minutes.

12.   CONTENT UNIFORMITY TEST: Take 10 suppositories; determine the active ingredients of each of the 10 suppositories by using a suitable analytical  method . If not more than one of the individual values thus  obtained  is outside the limit i.e.% of the average value and none of them is outside the limit i.e. 25% of the average value.

13. MELTING POINT DETERMINATION TEST: Melt the suppositories rapidly at a temperature not more than 10C above the point of complete fusion. Insert one end of glass capillary tube into the melted substance so that a column of substance become 8-12 high rise into it. Cool the tube to 15C and maintain the temperature at 15-17C for not less than 16 hours. Attached the tube to thermometer in the heating vessel containing water at 15C so that the lower end of the column of substance is 30mm below the surface of water. Heat the water with constant stirring, so that the temperature rise at a rate of 2C per minute. The temperature at which partially melted substance begins to rise in the tube is regarded as the melting point. The melting point of suppositories should not rise more than that given in the monograph.

14.   GENERAL APPEARANCE: The suppository when cut longitudinally and examined with the naked eye the internal and external surfaces of the suppository should be uniform in appearance. Compliance with the standard indicates satisfactory subdivision and dispersion of suspended material. Surface appearance and colour can be verified usually to assess absence of fissuring, absence of fissuring, absence of pitting, absence of exudation, absence of migration of the active ingredients.

15.   ASSAY OF ACTIVE CONTENTS : Official  limit for the active contents is 95- 105% e.g. Glycerol Suppositories. Dissolve a number of suppositories equivalent to 8 grams of glycerol in 50 ml of water and add quantity sufficient to produce 250ml. Take 5ml of this  solution  and 150ml of water and 0.25ml of Bromocresol purple solution and add 0.1M.NaOH to neutralize the blue color of indicator. Add 1.6 grams of sodium metaphenolate and  allow  to stand for 15 minutes and titrate with 0.1M NaOH to same blue color. Each ml of 0.1M NaOH =0.00921 grams of glycerol.

16. Liquefaction or Softening Time Tests of Rectal Suppositories . A Modification of the method developed by krowcynski is another useful test of finished suppositories. It consists of a U-tube partially submersed in a constant- temperature water bath. A constriction on one side hold the suppository in place in the tube. A glass rod is placed on top of the suppository, and the time for the rod to pass through to the constriction is recorded as the softening time. This can be carried out at various temperatures from 35.5 to 37 o c, as a quality control check and can also be studied as a measure of physical stability over time.

17. Brittleness of suppositories is a problem for which various solutions have already been described. The breaking test is designed as a method for measuring the fragility or brittleness of suppositories. The apparatus used for the test consists of a double-wall chamber in which the test suppository is placed. Water at 37 o c is pumped through the double walls of the chamber, and the suppository contained in the dry inner chamber, supports a disc to which a rod is attached. The other end of the rod consists of another disc to which weights are applied. The test is conducted by placing 600 g on the platform. Breaking test:

18. At 1-min intervals, 200-g weights are added, and the weight at which the suppository collapses is the breaking point, or the force that determines the fragility or brittleness characteristics of the suppository. Differently shaped suppositories have different breaking points. The desired breaking point of each of these variously shaped suppositories is established as the level that withstands the break forces caused by various types of handling i.e., production, packaging etc.

19. Dissolution Testing Testing for the rate of in vitro release of drug substances from suppositories has always posed a difficult problem, owing to melting deformation, and dispersion in the dissolution medium. Early testing was carried out by simple placement in a beaker containing a medium. In an effort to control the variation in mass or medium interface, various means have been employed, including a wire mesh basket, or a membrane, to separate the sample chamber from the reservoir. Samples sealed in dialysis tubing or natural membranes have also been studied. Flow cell apparatus have been used, holding the sample in place with cotton, wire screening and most recently with glass beads.

20. Conclusion: Advantages of Suppositories: These can be administered to children ,old person and to unconcious patients who cannot swallow the drug easily. These are inserted into the rectum to exert a direct and rapid action on the rectum. Disadvantages of suppositories: The irritant drugs cannot be administered by this route. The suppositories are required to be stored at low temperatures (10- 20 degree celsius ).

21. Bibliography: I am very much thankful to my professors to let me work on such a wonderful topic. Source: Pharmaceutics 2 by Rm Mehta and internet. Thank you.