Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

In-Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South Weast Ethiopia

Version 1 : Received: 5 April 2020 / Approved: 6 April 2020 / Online: 6 April 2020 (15:56:54 CEST)

How to cite: Abraham Leficho, W.; Abuye Lambore, H.; Kebede Olbemo, S.; Suleman Wega, S. In-Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South Weast Ethiopia. Preprints 2020, 2020040070 (doi: 10.20944/preprints202004.0070.v1). Abraham Leficho, W.; Abuye Lambore, H.; Kebede Olbemo, S.; Suleman Wega, S. In-Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South Weast Ethiopia. Preprints 2020, 2020040070 (doi: 10.20944/preprints202004.0070.v1).

Abstract

Persistent post market quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces biopharmaceutically and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the high cost barrier imposed by few expensive brands of the product. This study was aimed at determining the quality and evaluating equivalence of doxycycline hyclate capsules and tablets in Jimma, Ethiopia. Ten brands of doxycycline hyclate capsules and tablets were tested for physic-chemical parameters. All investigated brands of doxycycline complied with the USP for dosage unifor¬mity, assay of active ingredient and single-point dissolution tests. One brand, D09 failed both hardness and friabilty tests. Comparisons of dissolution profiles applying fit factors confirmed that only brands D04, D06 and D07 had similarity with innovator. Ratio test approaches also showed significant variability existence between test products and comparators. This may question the product’s being categorized as a <biowaiver> to mean in-vitro dissolution evaluation suffices its market approval. This work, however, found equivalence problems between ‘comparators’ and interchangeability issues among doxycycline different brands already distributed in the market.

Subject Areas

doxycycline; assay; dosage uniformity; hardness; friability; dissolution profile

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