Specification Setting and Manufacturing Process Control for Solid Oral Drug Products

Chen, W.; Stithit, Suchinda; Zheng, Jack

doi:10.1016/b978-0-12-802447-8.00025-x

Cited by 1 publication

(2 citation statements)

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“…There appears to be a direct correlation between the variation in the weight of individual capsules and the corresponding variation in the drug content [ 16 , 23 ]. The amount of granules placed in the body of a capsule will ultimately determine the weight of the encapsulated product [ 24 ]. Sampled brands of omeprazole capsules had weights of less than 300 mg.…”

Section: Resultsmentioning

confidence: 99%

“…Tere appears to be a direct correlation between the variation in the weight of individual capsules and the corresponding variation in the drug content [16,23]. Te amount of granules placed in the body of a capsule will ultimately determine the weight of the encapsulated product [24]. Sampled brands of omeprazole capsules had weights of less than 300 mg. Terefore, for a batch of such capsules to pass the weight uniformity test, not more than two of the individual weight of the capsules should deviate from the average weight by more than the percentage deviation of ±10%.…”

Section: Uniformity Ofmentioning

confidence: 99%

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Physicochemical Equivalence and Quality Assessment of Various Brands of Gastro-Resistant Omeprazole Capsules in the Kumasi Metropolis

Osei

Boakye

Bayor

et al. 2022

The Scientific World Journal

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The proliferation of counterfeit and poor-quality drugs is a major public health problem, especially in developing countries such as Ghana where there are inadequate resources to effectively monitor their prevalence. Most of these drugs, which are counterfeited, are drugs, which are in high demand and will reap huge profits for the unscrupulous people who engage in such activities. The introduction of Omeprazole as one of the first-line therapies in the management of peptic and duodenal ulcers in the treatment guidelines of Ghana has resulted in many generics being introduced onto the market. The pharmaceutical quality of fifteen randomly sampled Omeprazole capsule brands in the Kumasi metropolis was assessed using the innovator brand as a comparator to confirm their suitability for patient use and to provide data for drug regulatory agencies in Ghana concerning poor quality omeprazole brands. All the sampled brands complied with the official specifications for identification with good primary and secondary packaging characteristics. Ninety-four (94%) of the sampled brands passed the uniformity of weight test. All the brands (n = 16) representing 100% passed the disintegration tests. Sixty percent (60%) of the sampled brands passed the drug content test. Ten brands (66.7%) met the specification for in vitro dissolution test. From f2 analysis, the dissolution profiles of only five brands (31%) were similar to that of the reference brand which indicated that they could be used interchangeably in clinical practice. Conclusively, ten out of the fifteen sampled brands were of good quality and only five could be used as a substitute for the innovator. Thus, regulatory agencies will need to strengthen their postmarket surveillance to ensure that generic brands of good quality are allowed onto the market.

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Section: Resultsmentioning

confidence: 99%