Abstract

PHARMACEUTICAL ASSESSMENT OF FIVE DIFFERENT GENERIC BRANDS OF PREDNISOLONE TABLETS IN LIBYAN MARKET

Mohamed El Attug*, Amal Ammar, Asma Ben Ahmed, Hajer Alborawy, Alaa Mashina, Tarq Al Mug, Pradeep Velautham, Abdulmonem Gobassa, Emhemmed Elgallal

Abstract

Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 – 90 % cheaper than originator equivalents. Physicians often continue to prescribe brand-name drugs to their patients even when less expensive pharmacologically equivalent generic drugs are available. Unfortunately Physicians in general and Libyan Physicians in particular tend to prescribe brandname drugs, even without evidence of their therapeutic superiority, because neither they nor their insured patients bear these drugs’ increased cost with respect to generic substitutes. This study is to compare the quality of five different prednisolone tablets of the same strength from different companies under different trade names; Julphar, October pharma, Akums, Actavis, Pfizer compared them with pure prednisolone reference (BPCRS) using pharmacopeial and nonofficial methods. General quality tests of these tablets like weight variation, hardness, friability, disintegration time, dissolution and assay were determined according to pharmacopeial methods. Assay of generic products revealed that all samples contained between (90.0-110.0% w/w) of labelled chemical content and dissolution test not less than 70%. All products complied with the official specification; limits for friability, hardness tests, uniformity of weight and thickness uniformity, except Gupisone® from Julphar do not comply with the limits for the friability test, hardness and uniformity of weight.

Keywords: Quality Control, Pharmaceutical Analysis, Generic medicines, Prednisolone.