Ashok Kumar P

The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments. Make in India Campaign 2017 and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). These rules and regulations covers various aspects of device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post marketing requirements, etc. This study is aimed to review and compare the regulatory requirements of South African country with India. Harmonization of medical devices registration across the markets of these two country is essential to overlay way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance.

Bilayer floating tablets of Drotaverine HCL were developed by direct compression method. Immediate release layer contains 20 mg of drug and super disintegrant sodium starch glycolate, serves the purpose of loading dose. Sustained release layer contained HPMC K100, natural polymers like xanthan gum, guar gum, karaya gum release the drug for 12 hours’ time. Sodium bicarbonate and citric acid are used to produce effervescence. Floating lag time of optimized tablet is 92 sec, whereas floating duration is more than 12 hours. FTIR results revealed that there was no interaction between drug and HPMC K100 / xanthan gum. The post compression parameters of developed tablets were found to be satisfactory. In this study, it was confirmed that the formulations containing HPMC K100, have shown better floating properties and finally the formulation containing a combination of HPMC K100 and xanthan gum in 3:1 ratio, has exhibited decent sustained drug release properties. The release kinetics of optimized formulation prepared with the combination of HPMC K100 and xanthan gum followed zero order kinetics.

The main objective of this study is to improve the physicochemical stability, swelling and drug release pattern of the polymers in biological condition by Hybridization. In this study, interpenetrating polymer network (IPN) of acrylamide grafted ghatti gum (Am-g-GG) and poly vinyl alcohol (PVA) was developed by emulsion crosslinking method. Glutaraldehyde was used as the crosslinking agent. Experiments were performed according to a 23 factorial design to evaluate the effects of GG:PVA ratio, Glutaraldehyde and drug loading percentage on the percent Drug entrapment efficiency, percentage of Swelling at pH 1.2 & pH 6.8 and percentage Cumulative drug release. The effect of the three independent variables on the response variables was studied by response surface plots and contour plots generated by the Design-Expert software. The desirability function was used to optimize the response variables. The compatibility between Miglitol and the excipients was confirmed by differential FTIR spectroscopy analysis. The prepared IPN microspheres showed well controlled release characteristics and continued to drug release following a diffusion-controlled release pattern. The drug release was for a prolonged time without collapsing the IPN matrix. The observed responses taken were in good agreement with the experimental values. Thus, Miglitol IPN microspheres were produced with fewer experimental trials, and a patient compliant product with good stability was achieved with the concept of formulation by design.

Depressive Disorder medications are pharmacological agents that are used to treat Major Depressive Disorder disease. The intention of the present study is to design and characterization of fast dissolving buccal films of Paroxetin.  Films were prepared by using different polymers like HPMC E15, PVA, PVP and Glycerol as plasticizer and saccharin as a sweetening agent and vanillin as a flavoring agent. Buccal films were prepared using solvent casting technique. The major problem with Paroxetine was it belongs to class ? in BCS classification and have low solubility in biological fluids. In order to enhance the solubility of Paroxetine solid dispersion of Paroxetine   were prepared by melting technique at different drug carrier (PEG 4000) weight ratios and evaluated. No interaction was found between the drug and the polymers which was obtained by FTIR studies. The buccal films were evaluated for Folding endurance, weight variation, Drug content, Thickness, permeation study and in-vitro drug release study. Dissolution profile were studied by using USP dissolution apparatus type I, pH 6.8 simulated saliva were used as dissolution media. The influence of variable like polymer type, and their concentration, on Paroxetine release profile was studied. The formulation was optimized on the basis of various evaluation parameters like drug content and In-vitro drug release. Formulation F3 successfully gave the fast release of drug within 12 minutes. Stability studies were as per ICH guide lines and result indicated that the selected formulation was stable.