title: Choice of excipients for gelly-like pulp prepared ex tempore "on a spoon"- "placebo" and with sartans.
abstract: BACKGROUND
  To ensure safe oral administration, pediatric patients require an appropriate dosage form to be swallowed without relevant difficulties. Ex tempore hydrated powders, forming viscous pulp "on a spoon", have recently gained much interest as pediatric formulations. The aim of this study was to evaluate the viscosity-increasing substances and disintegrants, alone or in mixtures, as excipients suitable for preparing such formulations, with candesartan and valsartan chosen as model active substances.
  
  
  METHODS
  The mixtures of excipients were prepared in the form of powders, granules or lyophilizates, which were evaluated in terms of their ability to form a homogenous mass after hydration with a small amount of water. The best compositions were tested with candesartan cilexetil and valsartan (2% and 10% w/w, respectively). Performed studies include macroscopic, organoleptic and microscopic observations, as well as a textural analysis, determination of gelation time and rheological measurements.
  
  
  RESULTS
  Mixtures of guar gum, lactose and one of the disintegrants (F-Melt M, Prosolv 50, Prosolv Easy, Lycatab, Pharmaburst, Pearlitol) demonstrated the best properties. With regard to drug-incorporating formulations, granules were evaluated as the most satisfying form, while the functional properties of lyophilized formulations were poor.
  
  
  CONCLUSIONS
  Granules with candesartan cilexetil (2%) were found to be the most promising for further development.
authors.affiliation: a Department of Pharmaceutical Technology , Medical University of Gdansk , Gdansk , Poland.
authors.forename: Eliza
authors.initials: E
authors.lastname: Wolska
authors.affiliation: a Department of Pharmaceutical Technology , Medical University of Gdansk , Gdansk , Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Kluk
authors.affiliation: a Department of Pharmaceutical Technology , Medical University of Gdansk , Gdansk , Poland.
authors.forename: Magda
authors.initials: M
authors.lastname: Zarazińska
authors.affiliation: a Department of Pharmaceutical Technology , Medical University of Gdansk , Gdansk , Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Boniecka
authors.affiliation: a Department of Pharmaceutical Technology , Medical University of Gdansk , Gdansk , Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Sznitowska
mesh_terms: D000284:Administration, Oral; D047228:Angiotensin II Type 1 Receptor Blockers / Q000737:chemistry*; D001562:Benzimidazoles / Q000737:chemistry*; D001713:Biphenyl Compounds / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004337:Drug Carriers / Q000737:chemistry; D005079:Excipients / Q000737:chemistry*; D005612:Freeze Drying / Q000379:methods; D005685:Galactans / Q000737:chemistry; D007785:Lactose / Q000737:chemistry; D008351:Mannans / Q000737:chemistry; D053149:Plant Gums / Q000737:chemistry; D011208:Powders / Q000737:chemistry; D012212:Rheology; D013777:Tetrazoles / Q000737:chemistry*; D000068756:Valsartan / Q000737:chemistry*; D014783:Viscosity; D014867:Water / Q000737:chemistry
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D004337:Drug Carriers; D005079:Excipients; D005685:Galactans; D008351:Mannans; D053149:Plant Gums; D011208:Powders; D013777:Tetrazoles; D014867:Water; D000068756:Valsartan; C007894:guar gum; D007785:Lactose; C077793:candesartan cilexetil
keywords: Disintegrants; gels; granules; pediatric patients; powders