Ashok Kumar

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the markets of these two country is essential to overlay way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance.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.

A novel periodontal film for the treatment of periodontitis was developed by using herbal drug Quercetin, it is a plant flavanol from the flavonoid group of polyphenols. It is found in many fruits, vegetables, leaves, seeds and grains; capers and red onions. It has a bitter flavour and is used as an antimicrobial agent and effective against infecting microorganisms in the periodontal pocket. Calibration curves for Quercetin was developed in phosphate buffer PH 6.6, FT-IR studies was performed, which revealed that no interaction between the selected drug and polymers. Differential scanning calorimetry was performed to the identification of various physical properties and thermal transitions of drug and the polymeric materials. Periodontal films were prepared by solvent casting technique using Eutragit  and HPMC as polymers Dibutyl phthalate as plasticizers and PEG as surface active agent. The formulated periodontal films were evaluated for their folding endurance, percent moisture loss, surface pH, viscosity, thickness, uniformity of weight, content uniformity, and in-vitro release. Scanning electron microscopy was done to study the surface characteristics of the patch on placebo and optimized formulation F3 before dissolution and after dissolution. SEM analysis revealed that the drug was uniformly distributed in patch and drug was released by diffusion. Data of In-vitro release from the formulated periodontal films were fit to different equations and kinetic models to explain release kinetics. Kinetic models used were zero first-order equations and Higuchi models. The release mechanism was understood by fitting the data to Korsemeyer-Peppas model.

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.

The objective of this research work was to carry out design and evaluation of sustained release matrix tablets of Itopride by use of natural and synthetic polymers.  Matrix tablets were prepared by wet granulation technique by using natural polymers like Carbopol 934, Tamarind poly saccharide, Locust bean gum, Ethyl cellulose, HPMC K 100 as matrix forming agent and excipients such as Lactose, Starch 1500, Magnesium stearate, MCC and talc were used. The dissolution medium consisted of 900 ml of 0.1 N HCl for first 2 hours and then 7.4 phosphate buffer for remaining 10 hours. The release of Itopride from matrix containing lactose, micro crystalline cellulose and starch 1500 as diluents. The drug release rate was found in order of lactose> micro crystalline cellulose>starch 1500. The formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The release data were fit into different kinetic models (zero-order, first-order, Higuchi’s equation and Korsmeyer-Peppas equation). Optimized formulation was tested for their compatibility with Itopride by FT-IR studies, which revealed that there is no chemical interaction occurred with polymer and other excipients. The drug release profile of the best formulation was well controlled and uniform throughout the dissolution studies.

Bilayer floating tablets of Dothiepin HCL were developed by direct compression method. Immediate release layer contains 30 mg of drug and super disintegrant sodium starch glycolate, serves the purpose of loading dose. Sustained release layer contained HPMC K4M, 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 K4M / 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 K4M, have shown better floating properties and finally the formulation containing a combination of HPMC K4M 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 K4M and xanthan gum followed zero order kinetics.

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.

Anxiety disorders are marked by excessive fear, often in response to specific objects or situations and in the absence of true danger and they are extremely common in the general population. According to a recent epidemiological study, the lifetime prevalence of any anxiety disorder is 28.8%. Anxiety disorders are associated with impaired workplace performance and hefty economic costs. The clinical applications of benzodiazepines as anxiolytic are limited by their side effects. The aim of the present study is to investigate the effects of aqueous and ethanolic extracts of Solanum Nigrum leaves.  Elevated plus maze test, light/dark test used. In the elevated plus maze, aqueous and ethanolic extracts (400mg/kg; p.o) showed an anxiolytic effect by increasing the percentage of time spent in open arms and the percentage of open arm entries as compared to control group.. In the light/dark transition test, aqueous extracts (400mg/kg; p.o) had increased the time spent in light area, latency to enter dark chamber and tunnel crossing. Whereas, ethanolic extract of (400mg/kg; p.o) has showed significant result. These results suggested that the extracts of Solanum Nigrum leaves possessed anxiolytic effect in mice, in contrast to diazepam, had no inhibitory effect on locomotion in these tests, its side effect profile might be superior to the benzodiazepines.

The article aims at developing simple, fast and effective dissolution method for Dabigatran etexilate mesylate capsules by RP-HPLC and validate as per ICH guidelines. The optimized RP-HPLC method for dissolution studies uses a reverse phase column, Phenomenex Luna C18 (250 X 4.6 mm;5μ), a mobile phase of triethylammonium phosphate buffer (pH 3.0):acetonitrile in the proportion of 40:60 v/v, diluent as 0.01N HCl, flow rate of 1.0ml/min, injection volume as 20µl. and a detection wavelength of 341nm using a UV detector. The optimized dissolution conditions include, 0.01N HCl as dissolution media, apparatus as USP Type 1 Basket, rpm as 100, dissolution media temperature as 37±0.5ºC, dissolution volume as 500ml, dissolution time point as 30mts, working concentration of standard and sample as 5µg/ml and a detection wavelength of 341 nm. The developed method resulted in Dabigatran etexilate exhibiting linearity in the range 1.25-10μg/ml. System precision and intra-day precision is exemplified by relative standard deviation of 1.59% and 2.21% respectively. Method was found to be rugged/inter day precise as %RSD was found to be 3.25. Percentage Mean recovery was found to be greater than 80% at all the three levels by absolute method during accuracy studies. LOD and LOQ for Dabigatran etexilate were found to be 0.05ng/ml and 5ng/ml respectively. Hence it can be concluded that effective dissolution method by RP-HPLC is developed and validated as per ICH guidelines which can be applicable in various pharmaceutical industries.

Glaucoma is an optic neuropathy associated with retinal ganglion cell death that results in visual field loss. Elevated intraocular pressure (IOP) is a primary risk factor for the disease. Glaucoma is the second leading cause of blindness worldwide. Primary open angle glaucoma alone accounts for about 75% of all primary glaucoma. Timolol maleate (non selective β adrenergic antagonist) and Latanoprost (prostaglandin analogue) are commonly used drugs. Our aim of study is to compare the ocular hypotensive effect and safety of topical Timolol maleate (0.5%) and Latanoprost (0.005%) in patients of primary open angle glaucoma. A total of 60 patients with primary open angle glaucoma were included and studied for 6 months. One group of patients were given 0.5% timolol maleate eye drops twelve hourly and other group were given 0.005% latanoprost eye drops once a day. In our study both drugs were significantly effective in lowering the intraocular pressure. The mean fall in IOP in Timolol group was 6.69mmHg (26.10%) and in Latanoprost group was 7.20mmHg (28.5%) from pretreatment values. The difference between the values of mean of reduction in IOP from baseline IOP of the two groups was 0.512 mmHg that was statistically insignificant. The systemic and ocular side effects observed in two groups were comparable and both groups were well tolerated. Timolol maleate and Latanoprost both drugs are effective significantly in lowering the IOP, well tolerated and safe with negligible systemic side effects and comparable ocular side effects.