PARENTERAL CONTROLLED RELEASE DRUG DELIVERY SYSTEM

EVALUATION OF PARENTERALS: 

EVALUATION OF PARENTERALS Submitted to: Dr. Hemant Kumar S Yadav Dept. of Pharmaceutics JSSCP, Mysore Submitted by: Sarat Chandra Prasad. M 1 st M.pharm Department of pharmaceutics. 3/6/2012

Sterility testing: 

Sterility testing Sterility, or freedom from the presence of viable microorganisms, is a strict, uncompromising requirement of an injectable dosage form. In pharmaceutical manufacture, the sterility of a parenteral product lot is checked by a statistically valid sampling procedure. After years of experience, most manufacturers of parenteral products will sterility test 10 to 20 units of product per lot. 3/6/2012 1

Culture Medium: 

Culture Medium The USP and EP describe two primary types of culture media to be used in the sterility testing of parenteral products. F luid thioglycollate medium (FTM ) S oybean-casein digest (SCD ) or trypticase soy broth (TSB) medium 3/6/2012 3

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STERILITY TEST METHODS: 

STERILITY TEST METHODS Direct Transfer Method Basically , the DT method involves three steps: 1. Aseptically opening each sample container from a recently sterilized batch of product 2. Using a sterile syringe and needle to withdraw the required volume of sample 3. Incubate the inoculated media at 20- 25° C in case of soya been casein digest medium and 30 -35° C in case of fluid thio glycolate medium for not less than 14 days 3/6/2012 5

Membrane Filtration method: 

Membrane Filtration method Membrane filters of pore size not greater than 0.45 µm and diameter of about 47 mm are effective in retaining micro organisms. The membrane is then aseptically cut into equal halves. Incubate the medium at 30- 35° C. 3/6/2012 6

ISOLATION CHAMBERS AND ROBOTIC STERILITY TEST UNITS: 

ISOLATION CHAMBERS AND ROBOTIC STERILITY TEST UNITS F alse-positive sterility tests occur because of inadvertent contamination of the sample in the sterility test laboratory . Concerns over such unreliabilities of the sterility test have given rise to new technologies designed to remove as much as possible the human element involved in sterility testing. Schaeffer Engineering hard-walled isolation barrier system for sterility testing 3/6/2012 7

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LaCalhene isolation barrier system for sterility testing The VHP 1000 ® unit used for surface sterilization within isolators 3/6/2012 8

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(2) Particulate Matter Testing: 

(2) Particulate Matter Testing Lighting may be fluorescent, incandescent, spot, and/or polarized. The most common source of light is fluorescent. The range of light intensity may vary between 100 and 350 foot-candles.* This intensity can be achieved either with one 100-watt, inside-frosted incandescent light bulb or with three 15-watt fluorescent bulbs with the container held 10 inches from the light source. 3/6/2012 10

Autoskan System : 

Autoskan System The Autoskan system uses white light in contrast to laser light , which was used by the Prototron system to illuminate particles suspended in parenteral solutions. Particles will scatter the light, which is received by a television camera system. Any solution that contains particles will generate an error signal, and that product container will not be released by the Au toskan system at the accept station. Containers are also automatically rejected if they are either underfilled or overfilled. 3/6/2012 11

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Coulter counter method : Particles below 0.2 micro m can also be detected by this method . The voltage pulse created is proportional to the particle size, are amplified and are measured and counted 3/6/2012 12

(3)Pyrogene testing: 

(3)Pyrogene testing These are fever producing metabolic products of microorganisms Selection of test animals : Healthy adult rabbits should be taken . It shows a temperature variation greater than 0.2° C between two successive readings . Body temperature higher than 38° C 3/6/2012 13

PROCEDURE :: 

PROCEDURE : Normal readings of body temperature are taken prior to the injection of test solution . The test solution is injected to the ear vein of each rabbit .volume of injection is not less than 0.5 ml/kg and not more than 10 ml/kg of body weight Record the temperatures of each rabbit at an interval of the 30 minutes for 3 hours after injection. 3/6/2012 14

Interpretation of results: 

Interpretation of results If the response of any individual rabbit is less than 0.6°C and if the sum of the responses of 3 rabbits is more than 1.4°C, it passes the test. If the response of any rabbit is 0.6°C OR more OR if the sum of the responses of 3 rabbits is more than 1.4°C then same test is repeated on another 5 rabbits . If not more than 3 of the 8 rabbits show individual responses of 0.6°C OR more and if the sum of the responses is more than 3.7° C , Preparation passes the test 3/6/2012 15

(4) LAL ( limulus amoebocyte lysate ) test : 

(4) LAL ( limulus amoebocyte lysate ) test This is a sensitive test used to detect endotoxins from gram negative bacteria. Therefore it is also called as bacterial endotoxine test . Types : The gel clot test The turbidimetric test The kinetic chromogen test Limulus polyphemus 3/6/2012 16

The gel clot test: 

The gel clot test It is based on the formation of a solid gel clot Procedure : The lysate solution is mixed with an equal volume of the test solution .it is allowed to stand for 60 minutes now the tube is inverted and observed for formation of gel clot .the formation of solid gel confirms the presence of endotoxins and vice versa. 3/6/2012 17

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Turbidometric test Based on the measurement of opacity change in the LAL test due to formation of gel clot . Kinetic chromogen test It is based on the measurement of color change which is proportional to released chemical p - nitroanilide 3/6/2012 18

Bibilography : 

Bibilography Theory and practise of industrial pharmacy by leon lach man ,234-236. Novel drug delivery systems by robinson ,345-347. Parenteral Quality Control by Michael J. Akers and Daniel S. Larrimore, Newyork, 1-388. 3/6/2012 19

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Thank Q 3/6/2012 20