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Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride.
Drug Dev Ind Pharm. 2015; 41(7):1156-64.DD

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+Show Affiliations

Division of Product Quality Research, Office of Pharmaceutical Sciences (OPS), Food and Drug Administration (FDA) , Silver Spring, MD , USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25000481

Citation

Cantor, Stuart L., et al. "Development and Optimization of Taste-masked Orally Disintegrating Tablets (ODTs) of Clindamycin Hydrochloride." Drug Development and Industrial Pharmacy, vol. 41, no. 7, 2015, pp. 1156-64.
Cantor SL, Khan MA, Gupta A. Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride. Drug Dev Ind Pharm. 2015;41(7):1156-64.
Cantor, S. L., Khan, M. A., & Gupta, A. (2015). Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride. Drug Development and Industrial Pharmacy, 41(7), 1156-64. https://doi.org/10.3109/03639045.2014.935392
Cantor SL, Khan MA, Gupta A. Development and Optimization of Taste-masked Orally Disintegrating Tablets (ODTs) of Clindamycin Hydrochloride. Drug Dev Ind Pharm. 2015;41(7):1156-64. PubMed PMID: 25000481.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride. AU - Cantor,Stuart L, AU - Khan,Mansoor A, AU - Gupta,Abhay, Y1 - 2014/07/07/ PY - 2014/7/8/entrez PY - 2014/7/8/pubmed PY - 2016/3/30/medline KW - Clindamycin KW - coating KW - microcrystalline beads KW - orally disintegrating tablets KW - pediatrics KW - taste masking SP - 1156 EP - 64 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 41 IS - 7 N2 - 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. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/25000481/Development_and_optimization_of_taste_masked_orally_disintegrating_tablets__ODTs__of_clindamycin_hydrochloride_ L2 - http://www.tandfonline.com/doi/full/10.3109/03639045.2014.935392 DB - PRIME DP - Unbound Medicine ER -