title: Development of a taste-masked oral suspension of clindamycin HCl using ion exchange resin Amberlite IRP 69 for use in pediatrics.
abstract: OBJECTIVE
  The purpose of this study is to develop an oral suspension of clindamycin resin complex for the potential use in pediatrics.
  
  
  METHODS
  Several types of Ion exchange resins were screened for their binding efficiency with clindamycin. In order to develop a suspension formulation, several thickening agents, surfactants, sweeting, and flavoring agents were evaluated for their influence on the release of clindamycin from resinate. Rheological studies were also conducted to select the optimum amounts of the suspending agents. The release profiles of clindamycin in SGF and SIF were also evaluated from freshly prepared suspension and from suspension formulation after storage for 1 month at 25 °C and 40 °C. Clindamycin bitterness threshold was determined based on volunteers' evaluation, and taste evaluation was conducted in 12 adult volunteers who evaluated the taste of the optimized suspension against clindamycin solution.
  
  
  RESULTS
  Among all resins tested, Amberlite IRP 69 showed the highest binding efficiency to clindamycin. Several excipients were selected into the suspension formulation based on no or minimum influence on the release of clindamycin from the resinate complex. Moreover, xanthan gum was selected as the optimal suspending agent for the suspension. Clindamycin release profiles in SGF or SIF showed 90% release within 30 min from freshly prepared sample. Clindamycin exhibited good stability profiles at 25 °C and 40 °C over 1 month storage. The mean bitterness threshold of clindamycin was 12.5 μg/ml, and taste evaluation study in adults showed sustainable taste improvement for suspension over clindamycin solution.
  
  
  CONCLUSIONS
  Clindamycin/resin complexation has shown to be an efficient method to mask the taste of clindamycin and was developed into a suspension formulation that can be used in pediatrics.
authors.affiliation: a Department of Pharmaceutical Sciences , University of Tennessee Health Science Center , Memphis , TN , USA ;
authors.forename: Alaadin
authors.initials: A
authors.lastname: Alayoubi
authors.affiliation: b College of Pharmacy , Cairo University , Cairo , Egypt ;
authors.forename: Baher
authors.initials: B
authors.lastname: Daihom
authors.affiliation: c Department of Physics , University of Memphis , Memphis , TN , USA ;
authors.forename: Hitesh
authors.initials: H
authors.lastname: Adhikari
authors.affiliation: c Department of Physics , University of Memphis , Memphis , TN , USA ;
authors.forename: Sanjay
authors.initials: S
authors.lastname: Mishra
authors.affiliation: d Department of Clinical Pharmacy , University of Tennessee Health Science Center , Memphis , TN , USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Helms
authors.affiliation: a Department of Pharmaceutical Sciences , University of Tennessee Health Science Center , Memphis , TN , USA ;
authors.forename: Hassan
authors.initials: H
authors.lastname: Almoazen
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002981:Clindamycin / Q000008:administration & dosage / Q000737:chemistry*; D005079:Excipients; D006801:Humans; D007475:Ion Exchange Resins / Q000008:administration & dosage / Q000737:chemistry*; D010372:Pediatrics; D012117:Resins, Synthetic / Q000008:administration & dosage / Q000737:chemistry*; D013535:Suspensions / Q000008:administration & dosage / Q000737:chemistry* / Q000378:metabolism; D013607:Tablets; D013649:Taste; D013997:Time Factors
chemical_list: D005079:Excipients; D007475:Ion Exchange Resins; D012117:Resins, Synthetic; D013535:Suspensions; D013607:Tablets; D002981:Clindamycin; C406464:amberlite IRP 69
keywords: Amberlite IRP 69; clindamycin; ion exchange resin; pediatric formulations; taste masking