International Journal of Research in Pharmaceutical Sciences and Technology https://rubatosis.org/journals/index.php/ijrpst <p align="justify">Rubatosis Publication has launched its first online peer review scientific journal named International Journal of Research in Pharmaceutical Sciences and Technology (<strong>IJRPST, ISSN Online: 2581-9143</strong>). IJRPST will be published quarterly per year in January, April, July, and October. The journal publishes original research work that contributes significantly to further the scientific knowledge in Pharmaceutical Sciences and Technology.</p> en-US ijrpst.rubatosispublications@gmail.com (The Editor) journals@rubatosis.org (Publication Manger) Thu, 02 Jul 2020 06:13:39 +0000 OJS 3.1.2.2 http://blogs.law.harvard.edu/tech/rss 60 An overview on comparative study of registration requirements for generics in US, Canada and Europe https://rubatosis.org/journals/index.php/ijrpst/article/view/196 <p>Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country<strong>. </strong>To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market<strong>.</strong></p> Suryawanshi Meghraj , Jain minal Copyright (c) https://rubatosis.org/journals/index.php/ijrpst/article/view/196 Thu, 02 Jul 2020 06:20:14 +0000 Development and characterization of miconazole nitrate transfersomal gel https://rubatosis.org/journals/index.php/ijrpst/article/view/200 <p align="justify">Miconazole nitrate (MIC) is an antifungal drug used for the treatment of superficial fungal infections. However, it has low skin permeability. Hence, the basic idea behind the development of such a system, transfersomes is to maintain a sustain release of drug from the dosage form and for target delivery. Miconazole nitrate was formulated as transfersomes, half-life can be increased and the desired effect can be obtained. MIC transfersomes were prepared using a thin lipid film hydration technique. The prepared transfersomes were evaluated with respect to entrapment efficiency (EE%), particle size, and quantity of <em>in vitro</em> drug released to obtain an optimized formulation. The optimized formulation of MIC transfersomes was incorporated into a Carbapol 934 gel base which was for drug content, pH, spreadability, viscosity, <em>in vitro</em> permeation, and <em>in vitro</em> activity. The prepared MIC transfersomes had a high EE% ranging from 65.45% to 80.11%, with small particle sizes ranging from 368 nm to 931 nm. The <em>in vitro</em> release study suggested that there was an inverse relationship between EE% and <em>in vitro</em> release. In 24 hrs the drug release was observed ranging from 79.08% to 88.72%. The kinetic analysis of all release profiles was found to follow Higuchi’s diffusion model. All independent variables had a significant effect on the dependent variables (p-values &lt; 0.05). Therefore, Miconazole nitrate in the form of transfersomes has the ability to penetrate the skin, overcoming the stratum corneum barrier. When the data subjected to zero order and first order kinetics model, a linear relationship was observed with high R2 values for zero order model as compared to first order model and suggested that the formulations followed zero order sustained release.</p> Shaik Sajid Ali, Madhu Gudipati, Ramarao Nadendla Copyright (c) https://rubatosis.org/journals/index.php/ijrpst/article/view/200 Tue, 23 Jun 2020 00:00:00 +0000 Formulation and evaluation of lansoprazole loaded enteric coated microspheres https://rubatosis.org/journals/index.php/ijrpst/article/view/201 <p>The research focuses on the development of multiparticulate delivery system for acid-labile Lansoprazole to prevent its degradation in the acidic environment of the stomach and enhance its bioavailability via intestinal absorption. This problem can be solved by enteric coating. In this project, cellulose acetate phthalate a polymer usually utilized for gastrointestinal film coating of tablets, was used to prepare enteric microspheres of lansoprazole with solvent evaporation technique in various formulations such as F1, F2, F3, F4, F5 with drug: polymer ratios of 1:1, 1:2, 1:3, 1:4, 1:5 respectively. FTIR study indicated compatibility between drug and polymer. Increase in concentration of polymer increased spheriocity and mean diameter of the microspheres. The drug entrapment efficiency was in the range of 72.23% to 88.64%. SEM revealed that microspheres were found spherical and porous. In-vitro study proves that drug release slowly increases as the pH of the medium increased and prevents degradation of drug in acidic pH. In-vitro drug release was found to be 92.80%, 94.55%, 92.72%, 96.34%, 98.65% in all 5 formulations. All 5 formulations showed gastric resistance around 80-90%. So it is concluded that the developed enteric coated microspheres of Lansoprazole prevented drug release in the stomach which would lead to significant improvement in its bioavailability through enhanced intestinal absorption.</p> SK. Haneesha, M. Venkataramana, N. Ramarao Copyright (c) 2020 SK. Haneesha, M. Venkataramana, N. Ramarao https://creativecommons.org/licenses/by-nc-sa/4.0 https://rubatosis.org/journals/index.php/ijrpst/article/view/201 Thu, 02 Jul 2020 00:00:00 +0000 Formulation and evaluation of matrix tablets of Eperisone hydrochloride https://rubatosis.org/journals/index.php/ijrpst/article/view/203 <p>The aim of the present research is to develop and optimize Eperisone Hydrochloride extended release matrix tablets. Eperisone Hydrochloride is an antispasmodic drug mainly used to relieve pains it acts by relaxing the skeletal and smooth vascular muscles by blocking spinal reflexes drug which has oral bioavailability of 70% due to hepatic metabolism. Sustained release matrix tablets of Eperisone Hydrochloride were prepared through wet granulation technique by using HPMC K4M and EC as polymers, PVPK30 as binder, Magnesium stearate as lubricant and Talc as glidant. The granules of different formulations were determined for pre compression parameters. The prepared granules along with the excipients were then compressed. The formulated tablets were evaluated for physical characteristics viz. Hardness, Thickness, % Weight variation, Friability and the drug content. Furthermore the tablets evaluated for the <em>in vitro </em>release studies. Out of all the 8 formulations F7 showed desired characteristics in the physical parameters and <em>in vitro </em>drug release of 85.48% in 12hrs.The F7 dissolution data was best fitted to the Zero order model. The prepared Eperisone Hydrochloride matrix tablets found to be having a potential extended drug release.</p> Peruboina Neelima, Maddula Venkata Ramana Copyright (c) 2020 Peruboina Neelima, Maddula Venkata Ramana https://creativecommons.org/licenses/by-nc-sa/4.0 https://rubatosis.org/journals/index.php/ijrpst/article/view/203 Sun, 05 Jul 2020 18:53:15 +0000