Abstract
Objective: Due to quality of generic formulations depends on available information of reference drug products the aim of this work was to perform an in vitro dissolution study of two doses of propranolol-HCl and ranitidine-HCl reference tablets using USP basket or paddle apparatus and flow-through cell method.
 Methods: Two doses of propranolol-HCl (10-mg and 80-mg) and ranitidine-HCl (150-mg and 300-mg) of Mexican reference products were used. Dissolution profiles of propranolol-HCl were obtained with USP basket apparatus at 100 rpm and 1000 ml of 1% hydrochloric acid. Profiles of ranitidine-HCl were determined with USP paddle apparatus at 50 rpm and 900 ml of distilled water. All formulations were also studied with the flow-through cell method using laminar flow at 16 ml/min. Dissolution profiles were compared by model-independent (f2 similarity factor, mean dissolution time and dissolution efficiency) and model-dependent methods (dissolution data adjusted to some mathematical equations). Time data, derived from these adjustments, as t50%, t63.25%, and t85% were used to compare dissolution profiles.
 Results: With all approaches used and being high solubility drugs significant differences were found between low and high doses and between USP dissolution apparatuses (*P<0.05).
 Conclusion: In vitro dissolution performance of two doses of propranolol-HCl and ranitidine-HCl was not expected. Considering the same USP dissolution apparatus, the reference tablets did not allow the simultaneous release of the used doses. The results could be of interest for pharmaceutical laboratories or health authorities that classify some drug products as a reference to be used in dissolution and bioequivalence studies.
Highlights
Propranolol is a non-selective β-adrenergic receptor-blocking agent
The results could be of interest for pharmaceutical laboratories or health authorities that classify some drug products as a reference to be used in dissolution and bioequivalence studies
More than 85% of drug dissolved at 15 min is reached only by a high dose of ranitidine-HCl in United States Pharmacopoeia (USP) paddle apparatus
Summary
Propranolol is a non-selective β-adrenergic receptor-blocking agent. It is used to treat high blood pressure (hypertension) and severe infantile hemangioma [1]. Due to propranolol short biological halflife (3-5 h), it needs to be administered in two or three doses of 40 to 80 mg per day [2]. Ranitidine-HCl is a H2 receptor antagonist used in the treatment of gastric and duodenal ulceration and gastrooesophageal reflux disease. It is absorbed from the gastrointestinal tract with the bioavailability of about 50% and an elimination halflife of 3 h [3]. Chemical structures of used drugs are shown in fig. Chemical structures of used drugs are shown in fig. 1
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