Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride

Abstract

The purpose of this research was to develop an orally disintegrating tablet (ODT) dosage form containing taste-masked beads of clindamycin HCl. Several formulation strategies were evaluated and a taste-masked ODT of clindamycin HCl was prepared without the use of a waxy cushioning agent. Clindamycin HCl (ca. 46% w/w) was coated onto microcrystalline cellulose beads (Cellets® 200) followed by the addition of a taste-masking layer of amino methacrylate copolymer, NF (Eudragit EPO® (EPO)) coating suspension. The efficiency of both the drug coating process and the taste-masking polymer coating process, as well as the taste masking ODTs was determined using potency and drug release analysis. Magnesium stearate was found to be advantageous over talc in improving the efficiency of the EPO coating suspension. A response surface methodology using a Box-Behnken design for the tablets revealed compression force and levels of both disintegrant and talc to be the main factors influencing the ODT properties. Blending of talc to the EPO-coated beads was found to be the most critical factor in ensuring that ODTs disintegrate within 30 s. The optimized ODTs formulation also showed negligible (<0.5%) drug release in 1 min using phosphate buffer, pH 6.8 (which is analogous to the residence time and pH in the oral cavity). By carefully adjusting the levels of coating polymers, the amounts of disintegrant and talc, as well as the compression force, robust ODTs can be obtained to improve pediatric and geriatric patient compliance for clindamycin oral dosage forms.

Insights Into Formulation Technologies and Novel Strategies for the Design of Orally Disintegrating Dosage Forms: A Comprehensive Industrial Review

“…Cantor et al [115] described a novel formulation approach for tastemasking drugs with poor organoleptic properties such as clindamycin hydrochloride. Taste-masked ODTs of clindamycin hydrochloride were prepared by its coating with microcrystalline cellulose beads followed by the addition of a taste-masking layer of amino methacrylate copolymer coating suspension.…”

Nanosponge-based pediatric-controlled release dry suspension of Gabapentin for reconstitution

“…Taste masking is a challenge for oral preparations such as orodispersible tablets [5][6][7] and liquid preparations like solutions and suspensions. There are many techniques available for taste masking of bitter formulation such as addition of sweeteners and flavors, coating with polymers, adsorption to ionexchange resin and chemical modifications such as the use of insoluble prodrugs 8 . However, the addition of sweeteners and flavors is not very successful for extremely bitter drugs.…”

Excipient Variability and Its Impact on Dosage Form Functionality

“…), enhance aesthetics (e.g., identification, branding, etc. ), optimize product performance (e.g., modified drug release), and/or to facilitate patient compliance (e.g., taste masking). Excipients are found ubiquitously as an indispensable part of virtually every pharmaceutical formulation to serve one or more of the above‐mentioned purposes.…”