title: Investigation of Biowaivers for Immediate Release Formulations Containing BCS III Drugs, Acyclovir, Atenolol, and Ciprofloxacin Hydrochloride, Using Dissolution Testing.
abstract: The dissolution of several products containing Biopharmaceutical Classification System (BCS) class III drugs, acyclovir, atenolol, and ciprofloxacin hydrochloride, listed in the WHO essential drug list (EDL), was tested and compared with their respective comparator pharmaceutical products (CPPs) marketed in South Africa and India. US Pharmacopeia (USP) buffers of pH 1.2, 4.5, and 6.8 were used as dissolution media and tested using USP apparatus 2 at 75 rpm and 900 ml. Nine acyclovir products were tested, and only three dissolved very rapidly in all media; i.e., they showed a release of >85% in 15 min. Eight atenolol products tested were all very rapidly dissolving in all three pH media. Ten ciprofloxacin hydrochloride products were tested, and the results showed that only five products met the WHO biowaiver criteria. This study indicates that not all marketed products containing the same BCS III active pharmaceutical ingredient (API) in similar strength and dosage form are necessarily in vitro equivalent as per the WHO biowaiver criteria. Furthermore, selection and availability of an innovator product as CPP are important considerations that can affect the outcomes of such studies.
authors.affiliation: Basic Sciences Research Center, KLE University, Belgaum, 590010, Karnataka, India.
authors.forename: Nallagundla H S
authors.initials: NH
authors.lastname: Reddy
authors.affiliation: Department of Chemistry, Rhodes University, Grahamstown, 6139, South Africa.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Patnala
authors.affiliation: Division of Pharmaceutics, Faculty of Pharmacy, Rhodes University, Grahamstown, 6139, South Africa. I.Kanfer@ru.ac.za.
authors.forename: Isadore
authors.initials: I
authors.lastname: Kanfer
mesh_terms: D000212:Acyclovir / Q000737:chemistry*; D001262:Atenolol / Q000737:chemistry*; D001702:Biopharmaceutics / Q000379:methods; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002939:Ciprofloxacin / Q000737:chemistry*; D004304:Dosage Forms; D007194:India; D012995:Solubility; D013019:South Africa; D013810:Therapeutic Equivalency
chemical_list: D004304:Dosage Forms; D001262:Atenolol; D002939:Ciprofloxacin; D000212:Acyclovir
keywords: Biopharmaceutics Classification System; comparator pharmaceutical product; dissolution; innovator