Faculty Articles

PubMed Identifier

21523516

Dissolution testing of sublingual tablets: a novel in vitro method

Publication Title

AAPS PharmSciTech [electronic resource]

Publication Date

6-1-2011

Keywords

Administration, Sublingual, Chemistry, Pharmaceutical, Pharmaceutical Preparations, Solubility, Tablets

Abstract

In the sublingual (SL) cavity, compared with the gastrointestinal tract, tablets are subjected to minimal physiological agitation, and a limited volume of saliva is available to facilitate disintegration and dissolution. None of the official compendial dissolution apparatuses and methods simulate these SL conditions. In this study, a custom-made dissolution apparatus was constructed, and a novel in vitro method that simulates SL conditions was evaluated. Several epinephrine 40 mg SL tablet formulations under development and two commercial SL tablets, isosorbide dinitrate 5 mg and nitroglycerin 0.6 mg, were studied. The dissolution medium was 2 mL of distilled water at 25°C. Dissolution was measured at 60 and 120 s. The novel in vitro method was validated for accuracy, reproducibility, and discrimination capability, and was compared with the official US Pharmacopeia (USP) dissolution method using apparatus 2 (Paddle). The data obtained following the novel in vitro method were accurate and reproducible. This method was capable of detecting minor changes in SL formulations that could not be detected using other in vitro tests. Results from the official USP dissolution method and our novel in vitro method were significantly different (p < 0.05). Results reflecting the dissolution of rapidly disintegrating tablets using simulated SL conditions were obtained using the novel in vitro dissolution method.

DOI

10.1208/s12249-011-9615-0

Volume

12

Issue

2

First Page

544

Last Page

552

Disciplines

Medicine and Health Sciences | Pharmacy and Pharmaceutical Sciences

Link to Full Text
Peer Reviewed

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