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Preparation and evaluation of taste masked famotidine formulation using drug/beta-cyclodextrin/polymer ternary complexation approach.
AAPS PharmSciTech. 2008; 9(2):544-50.AP

Abstract

The main aim of the present study was to evaluate potential of ternary complexation (comprising of drug, cyclodextrin and polymer) as an approach for taste masking. For this purpose famotidine with property of bitter taste was selected as a model drug. Improvement in taste masking capability of cyclodextrin towards famotidine was evaluated by formulating a ternary complex including hydrophilic polymer hydroxyl propyl methyl cellulose (HPMC 5 cps) as the third component. Phase solubility analysis at 25 degrees C was carried out for both the binary systems (viz. drug-cyclodextrin and drug-polymer) and the ternary system (drug-cyclodextrin-polymer). Ternary complex was prepared using solution method and was further characterized using XRD, DSC, FT-IR and microscopic studies. In vitro dissolution study was carried out to see the effect of ternary complexation on drug release. Taste perception study was carried out on human volunteers to evaluate the taste masking ability of ternary complexation. Results obtained from phase solubility analysis showed that the combined use of polymer and cyclodextrin effectively increased the stability constant of the complex [from 538 M(-1) for binary system to 15,096 M(-1) for ternary system]. Ternary system showed effective taste masking as compared to binary complex and at the same time showed no limiting effect on the drug release (D.E(15min) = 90%). The effective taste masking was attributed to the enhanced complexation of famotidine in ternary system compared to binary system and the same was confirmed from the characterization studies. In conclusion, the study confirmed that ternary complexation can be utilized as an alternative approach for effective taste masking.

Authors+Show Affiliations

Centre for Novel Drug Delivery Systems, Department of Pharmaceutical Sciences, University Institute of Chemical Technology, Matunga, Mumbai 400019, India.No affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18431648

Citation

Patel, Ashok R., and Pradeep R. Vavia. "Preparation and Evaluation of Taste Masked Famotidine Formulation Using Drug/beta-cyclodextrin/polymer Ternary Complexation Approach." AAPS PharmSciTech, vol. 9, no. 2, 2008, pp. 544-50.
Patel AR, Vavia PR. Preparation and evaluation of taste masked famotidine formulation using drug/beta-cyclodextrin/polymer ternary complexation approach. AAPS PharmSciTech. 2008;9(2):544-50.
Patel, A. R., & Vavia, P. R. (2008). Preparation and evaluation of taste masked famotidine formulation using drug/beta-cyclodextrin/polymer ternary complexation approach. AAPS PharmSciTech, 9(2), 544-50. https://doi.org/10.1208/s12249-008-9078-0
Patel AR, Vavia PR. Preparation and Evaluation of Taste Masked Famotidine Formulation Using Drug/beta-cyclodextrin/polymer Ternary Complexation Approach. AAPS PharmSciTech. 2008;9(2):544-50. PubMed PMID: 18431648.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preparation and evaluation of taste masked famotidine formulation using drug/beta-cyclodextrin/polymer ternary complexation approach. AU - Patel,Ashok R, AU - Vavia,Pradeep R, Y1 - 2008/04/22/ PY - 2007/10/27/received PY - 2008/02/04/accepted PY - 2008/4/24/pubmed PY - 2008/9/16/medline PY - 2008/4/24/entrez SP - 544 EP - 50 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 9 IS - 2 N2 - The main aim of the present study was to evaluate potential of ternary complexation (comprising of drug, cyclodextrin and polymer) as an approach for taste masking. For this purpose famotidine with property of bitter taste was selected as a model drug. Improvement in taste masking capability of cyclodextrin towards famotidine was evaluated by formulating a ternary complex including hydrophilic polymer hydroxyl propyl methyl cellulose (HPMC 5 cps) as the third component. Phase solubility analysis at 25 degrees C was carried out for both the binary systems (viz. drug-cyclodextrin and drug-polymer) and the ternary system (drug-cyclodextrin-polymer). Ternary complex was prepared using solution method and was further characterized using XRD, DSC, FT-IR and microscopic studies. In vitro dissolution study was carried out to see the effect of ternary complexation on drug release. Taste perception study was carried out on human volunteers to evaluate the taste masking ability of ternary complexation. Results obtained from phase solubility analysis showed that the combined use of polymer and cyclodextrin effectively increased the stability constant of the complex [from 538 M(-1) for binary system to 15,096 M(-1) for ternary system]. Ternary system showed effective taste masking as compared to binary complex and at the same time showed no limiting effect on the drug release (D.E(15min) = 90%). The effective taste masking was attributed to the enhanced complexation of famotidine in ternary system compared to binary system and the same was confirmed from the characterization studies. In conclusion, the study confirmed that ternary complexation can be utilized as an alternative approach for effective taste masking. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/18431648/Preparation_and_evaluation_of_taste_masked_famotidine_formulation_using_drug/beta_cyclodextrin/polymer_ternary_complexation_approach_ L2 - https://dx.doi.org/10.1208/s12249-008-9078-0 DB - PRIME DP - Unbound Medicine ER -