title: Montmorillonite Poly-L-Lactide Microcomposites of Procainamide for controlled drug delivery: In vitro and In vivo evaluation.
abstract: The research work reported in this paper is extension of our previous findings related to intercalation of procainamide hydrochloride, an antiarrythmia drug in interlayer gallery of Na(+)-clay (montmorillonite). The microcomposite particles prepared from procainamide-montmorillonite hybrid and poly L-lactide were characterised by scanning electron microscope and atomic force microscopy analysis. In vitro drug release study in simulated intestinal fluid showed controlled release pattern up to ~72 h and significant reduction in the drug release in gastric environment. In vivo pharmacokinetics and biodistribution in rats showed that the plasma/tissue drug levels were within therapeutic window as compared with free drug. The data from toxicity biomarker estimations and clinical biochemistry/haematological parameters showed significant reduction in drug toxicity when formulated in montmorillonite/poly L-lactide as compared with free drug, which is of considerable value in achieving improved therapy with reduced side effects.
authors.affiliation: Institute of Science, Nirma University, S. G. highway, Ahmedabad-382 481, India.
authors.forename: B D
authors.initials: BD
authors.lastname: Kevadiya
authors.affiliation: Department of Pharmacology, Government Medical College, Bhavnagar University, Jail road, Bhavnagar-364 002, India.
authors.forename: T K
authors.initials: TK
authors.lastname: Patel
authors.affiliation: Department of Pharmacology, Government Medical College, Bhavnagar University, Jail road, Bhavnagar-364 002, India.
authors.forename: Parvati B
authors.initials: PB
authors.lastname: Patel
authors.affiliation: Institute of Science, Nirma University, S. G. highway, Ahmedabad-382 481, India.
authors.forename: Shalini
authors.initials: S
authors.lastname: Rajkumar
authors.affiliation: Department of Pharmacology, Government Medical College, Bhavnagar University, Jail road, Bhavnagar-364 002, India.
authors.forename: C B
authors.initials: CB
authors.lastname: Tripathi
authors.affiliation: Discipline of Inorganic Materials and Catalysis, Central Salt and Marine Chemicals, Research Institute, Council of Scientific and Industrial Research (CSIR), Gijubhai Badheka Marg, Bhavnagar-364 002, India.
authors.forename: H C
authors.initials: HC
authors.lastname: Bajaj
keywords: Antiarrythmia; controlled release; microcomposites; procainamide; toxicity biomarker