title: Varying efficacy of superdisintegrants in orally disintegrating tablets among different manufacturers.
abstract: OBJECTIVE
  The main objective of the present study was to develop an orally disintegrating tablet formulation of domperidone and to study the functionality differences of superdisintegrants each obtained from two different sources on the tablet properties.
  
  
  METHODS
  Domperidone tablets were formulated with different superdisintegrants by direct compression. The effect of the type of superdisintegrant, its concentration and source was studied by measuring the in-vitro disintegration time, wetting time, water absorption ratios, drug release by dissolution and in-vivo oral disintegration time.
  
  
  RESULTS
  Tablets prepared with crospovidone had lower disintegration times than tablets prepared from sodium starchglycolate and croscarmellose sodium. Formulations prepared with Polyplasdone XL, Ac-Di-Sol, and Explotab (D series) were better than formulations prepared with superdisintegrants obtained from other sources (DL series) which had longer disintegration times and lower water uptake ratios. The in-vivo disintegration time of formulation D-106 containing polyplasdone XL was significantly lower than that of the marketed formulation Domel-MT.
  
  
  CONCLUSIONS
  The results from this study suggest that disintegration of orally disintegrating tablets is dependent on the nature of superdisintegrant, concentration in the formulation and its source. Even though a superdisintegrant meets USP standards there can be a variance among manufacturers in terms of performance. This is not only limited to in-vitro studies but carries over to disintegration times in the human population.
authors.affiliation: Department of Pharmaceutical Sciences, School of Pharmacy, Texas Tech University HSC, Amarillo, Texas 79106-1712, USA. rajendar.mittapalli@ttuhsc.edu
authors.forename: R K
authors.initials: RK
authors.lastname: Mittapalli
authors.forename: H S Sha
authors.initials: HS
authors.lastname: Qhattal
authors.forename: P R
authors.initials: PR
authors.lastname: Lockman
authors.forename: M R
authors.initials: MR
authors.lastname: Yamsani
mesh_terms: D000042:Absorption; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D005079:Excipients; D006244:Hardness; D006801:Humans; D007700:Kinetics; D009055:Mouth; D011205:Povidone; D012995:Solubility; D013607:Tablets; D014867:Water / Q000737:chemistry
chemical_list: D005079:Excipients; D013607:Tablets; D014867:Water; D011205:Povidone