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Berita Ubat-ubatan
November 1998
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Seminar on Pharmacovigilance
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Mandatory ADR Reporting of New Chemical Entities
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Nifedipine – Induced Hypotensive Shock
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Licensing – Ten Years of Implementation
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Stage I Application Form Amended (434.1)
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Comparative Dissolution Performance of Locally Available Piroxicam Products
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Clinical Trials
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New Chemical Entity Approved For Marketing In Malaysia
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New Indications Approved For Registration
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International Visitors and Delegation
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NPCB – Contact Person

 line_vertical.gif (147 bytes) line1.jpg (4914 bytes) Comparative Dissolution Performance of Locally Available Piroxicam Products

 
ABSTRACT Piroxicam is a widely used nonsteroidal antiinflammatory drug available under various trade names by several manufactures. The innovator’s product, Pfizer branded FELDENE is in the form of capsules but some local manufacturers have formulated the generic Piroxicam in tablet form. The objective of the study was to evaluate and compare the dissolution performance of several piroxicam tablets and capsules available in Malaysian markets. Thirty two products of Piroxicam capsules and tablets were evaluated according to the dissolution requirement specified in the USP 23 monograph. Although there is no specific USP dissolution test for tablets, the test for capsules was applied to the six products of Piroxicam tablets.

TESTED
Overall 32 products Capsules 26 products Tablets 6 products 20mg strength 14 products 10mg strength 18 products
PASSED
Overall 16 products (50%) Capsules 15 products (58%) Tablets 1 product (17%) 20mg strength 3 products (21%) 10mg Strength 13 products (72%)
FAILED
Overall 16 products (50%) Capsules 11 products (42%) Tablets 5 products (83%) 20mg strength 11 products (79%) 10mg strength 5 products (28%)

 

The table above summarized the results of the study. Overall, Piroxicam capsules gave better dissolution performance than Piroxicam tablets. Out of the 26 Piroxicam capsule products tested 57% passed the USP dissolution test where as out of the 6 Piroxicam tablets products tested, only one product passed. This particular Piroxicam tablet managed to meet the dissolution criteria only at Stage 11. The study also indicated that Piroxicam products in smaller strength (10mg) gave better dissolution performance than the 20mg strength. Out of 13 products (10mg) tested, 72% passed dissolution test whereas only 21% of the 20mg strength met the dissolution requirements.

Imported Piroxicam products gave better dissolution results than local Piroxicam.

Although comparative bioavailability studies would be required to establish any definitive relationship between dissolution test performance and bioavailability, the failure of most of these products to meet the USP requirement for dissolution indicates formulation differences that could result in altered bioavailability.

The above study was conducted by Puan Faridah Abdul Malek, Head of Pharmaceutical Technology, Laboratory, National Pharmaceutical Control Bureau. M.O.H.