Montmorillonite Poly-L-lactide microcomposites of procainamide for controlled drug delivery: In vitro and in vivo evaluation
1Institute of Science, Nirma University, S. G. highway, Ahmedabad-382 481, India. 2Department of Pharmacology, Government Medical College, Bhavnagar University, Bhavnagar-364 002, India. 3Research Institute, Council of Scientific and Industrial Research (CSIR), Bhavnagar-364 002, India.
H C Bajaj Discipline of Inorganic Materials and Catalysis, , Council of Scientific and Industrial Research (CSIR), Gijubhai Badheka Marg, Bhavnagar. E-mail: [email protected]
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.