title: Preparation and characterization of a gastric floating dosage form of capecitabine.
abstract: Gastrointestinal disturbances, such as nausea and vomiting, are considered amongst the main adverse effects associated with oral anticancer drugs due to their fast release in the gastrointestinal tract (GIT). Sustained release formulations with proper release profiles can overcome some side effects of conventional formulations. The current study was designed to prepare sustained release tablets of Capecitabine, which is approved by the Food and Drug Administration (FDA) for the treatment of advanced breast cancer, using hydroxypropyl methylcellulose (HPMC), carbomer934P, sodium alginate, and sodium bicarbonate. Tablets were prepared using the wet granulation method and characterized such that floating lag time, total floating time, hardness, friability, drug content, weight uniformity, and in vitro drug release were investigated. The sustained release tablets showed good hardness and passed the friability test. The tablets' floating lag time was determined to be 30-200 seconds, and it floated more than 24 hours and released the drug for 24 hours. Then, the stability test was done and compared with the initial samples. In conclusion, by adjusting the right ratios of the excipients including release-retarding gel-forming polymers like HPMC K4M, Na alginate, carbomer934P, and sodium bicarbonate, sustained release Capecitabine floating tablet was formulated.
authors.affiliation: Department of Pharmacy, Faculty of Medicine, Universiti of Malaya, 50603 Kuala Lumpur, Malaysia.
authors.forename: Ehsan
authors.initials: E
authors.lastname: Taghizadeh Davoudi
authors.forename: Mohamed
authors.initials: M
authors.lastname: Ibrahim Noordin
authors.forename: Ali
authors.initials: A
authors.lastname: Kadivar
authors.forename: Behnam
authors.initials: B
authors.lastname: Kamalidehghan
authors.forename: Abdoreza Soleimani
authors.initials: AS
authors.lastname: Farjam
authors.forename: Hamid
authors.initials: H
authors.lastname: Akbari Javar
mesh_terms: D000180:Acrylic Resins / Q000008:administration & dosage / Q000737:chemistry; D000464:Alginates / Q000008:administration & dosage / Q000737:chemistry; D001943:Breast Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D002626:Chemistry, Pharmaceutical; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000737:chemistry; D054796:Drug Dosage Calculations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000737:chemistry; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000473:pathology; D020723:Glucuronic Acid / Q000008:administration & dosage / Q000737:chemistry; D006603:Hexuronic Acids / Q000008:administration & dosage / Q000737:chemistry; D006801:Humans; D065347:Hypromellose Derivatives; D008747:Methylcellulose / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000737:chemistry; D017693:Sodium Bicarbonate / Q000008:administration & dosage / Q000737:chemistry; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000180:Acrylic Resins; D000464:Alginates; D006603:Hexuronic Acids; D003841:Deoxycytidine; D065347:Hypromellose Derivatives; C006903:carbopol 940; D000069287:Capecitabine; D020723:Glucuronic Acid; D017693:Sodium Bicarbonate; D008747:Methylcellulose; D005472:Fluorouracil