title: 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.
authors.affiliation: Division of Product Quality Research, Office of Pharmaceutical Sciences (OPS), Food and Drug Administration (FDA) , Silver Spring, MD , USA.
authors.forename: Stuart L
authors.initials: SL
authors.lastname: Cantor
authors.forename: Mansoor A
authors.initials: MA
authors.lastname: Khan
authors.forename: Abhay
authors.initials: A
authors.lastname: Gupta
mesh_terms: D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000737:chemistry; D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002981:Clindamycin / Q000008:administration & dosage* / Q000737:chemistry; D065546:Drug Liberation; D005079:Excipients / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D011109:Polymethacrylic Acids / Q000737:chemistry; D013229:Stearic Acids / Q000737:chemistry; D013607:Tablets; D013627:Talc / Q000737:chemistry; D013649:Taste
chemical_list: D000900:Anti-Bacterial Agents; D005079:Excipients; D011109:Polymethacrylic Acids; D013229:Stearic Acids; D013607:Tablets; D013627:Talc; C038300:methylmethacrylate-methacrylic acid copolymer; D002981:Clindamycin; C031183:stearic acid; D002482:Cellulose; C109691:microcrystalline cellulose
keywords: Clindamycin; coating; microcrystalline beads; orally disintegrating tablets; pediatrics; taste masking