Quality control of ranitidine hydrochloride compounded capsules

Abstract

The class of medicines most used for the treatment of gastric disorders is histamine H2 receptor inhibitors, reducing the gastric acid secretion. Ranitidine hydrochloride is one of the most used agents of this class, usually found as 150 and 300 mg tablets. Dispensing extemporaneous compounds has been shown as alternative when patient seeks for medicines with personalized doses or lower cost, resulting in a progressive increase of this type of medicine. Aiming to evaluate the quality of extemporaneous compounding, this work verified the quality of ranitidine hydrochloride capsules from three compounding pharmacies (F1, F2 and F3) of the state of Mato Grosso. Trials were conducted according to Brazilian Pharmacopeia. Results showed that compounded capsules from F1 and F3 met the Brazilian Pharmacopeia specifications while the F2 ones were out of specification limits. Therefore, it was observed that it is needed a strict control over the compounding process to assure quality, effective and safe products.

Keywords

• control
• quality
• ranitidine hydrochloride
• capsule