MIT-World Peace University (MIT-WPU) is a top educational institute located in Pune, India. It is recognized within&nbsp;UGC under Government of Maharashtra Act No. XXXV 2017.&nbsp;

It is part of the MIT group of institutions (established in 1983) which covers 10+ campuses across India and has more than 50,000+ students enrolled across various disciplines at a given point of time. The institute houses 15 schools ranging from Engineering &amp; Technology, Design, Pharmacy, Commerce, Governance among others. It offers undergraduate, postgraduate and PhD programs among different disciplines.&nbsp;

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MIT World Peace University

School of Pharmacy

Pharmacy

Indo American Journal of Pharmaceutical Research

APPLICATION OF CO-CRYSTALS TECHNOLOGY IN PHARMACEUTICALS

Objective: As a condition of acceptance and approval of any pharmaceutical product, stability studies ensuring the durability of the consistency, stability and efficacy of the product during the shelf life are taken into consideration. These studies should be conducted according to the guidelines provided by ICH, WHO and other agencies as intended. Methods: The aim of this research was to evaluate the stability of the budesonide solution in some solutions and excipients and to further study the production of budesonide nanoparticles. In order to study the Budesonide stability mixture of solvent and polymers were used. To study the effect of temperature and relative humidity on the stability of budesonide preparations, prepared mixtures were stored under Accelerated (40 °C±2 °C/75 percent RH±5 percent RH), Intermediate (30 °C±2 °C/65 percent RH±5 percent RH), Long-term (25 °C±2 °C/60 percent RH±5 percent RH) and at 2-8 °C. Results: Budesonide showed good compatibility at defined stability conditions in one month. Such type of preformulation compatibility study is necessary in preparation of nanoparticles. Conclusion: It would be helpful in screening and identifying a suitable solvent, polymer and mixture at a desired concentration.

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International Journal of Current Pharmaceutical Research

Budesonide Compatibility Study With Excipients for Preparation of Nanoparticle

The sustained release matrix dosage type is favored to prevent blood level variations found in the Dipyridamole drug. The goal of this research was to formulate Dipyridamole's sustained release matrix tablet, Dipyridamole is a thromboembolic risk preventive drug for heart valve replacement and long-term angina pectoris treatment will be well absorbed in the stomach. Maintaining long-term therapeutic plasma concentration and increasing bioavailability by using various polymers to improve bioavailability and to minimize the dosing rate and side effects by integrating a 3-factor, 3-level Box-Behnken statistical design of surface response technique. Sustain release polymers such as HPMC K4M (X1), MCC 101 (X2) and Magnesium Stearate (X3) are the dependent variables and Independent variable is the percentage release of drug at 12 h (Y1) were determined. Response surface plots of Box-Behnken design have been drawn, quadratic models have been statistically validated and optimized formulations have been selected Based on grid search and feasibility. The physical evaluation, drug content and % drug release tests were conducted on all the 13 box Behnken design runs. Zero order, first order, Higuchi and Korsemayer-peppas in terms of r2 and n-value were generated using various release kinetic models and equations. The response surface plots showed high degree of prediction. The desired batch depicted a steady and sustained release from the confirmatory runs (best fit model– Higuchi model (n=0.9862). Hence, the bioavailability of Dipyridamole cocrystal sustained release matrix tablets was increased using response surface designs.

Research Journal of Pharmacy and Technology

Development and evaluation of dipyridamole matrix tablets using response surface methodology

Aims: Nanoparticles are the colloidal carrier systems for delivery of poorly soluble drugs. Budesonide. (BUD) a corticosteroid practically insoluble in water is used in asthma treatment. The aim of the present research work was to develop and evaluate BUD nanoparticles. Methodology: The prepared formulation was analyzed for % encapsulation efficiency, particle size analysis, zeta potential, polydispersity index (PDI), scanning electron microscopy and transmission electron microscopy. Poloxamer-188 was found in stabilizing BUD nanoparticles. Results: The observed % encapsulation efficiency of the optimized batch was (82.95) %, particle size was 271.8 nm with PDI 0.456. Solvent injection method was successfully implemented to developed BUD nanoparticles poloxamer-188. Sonication time and amplitude played an important role in governing the particle size. Conclusion: It can be inferred from the study that nanoparticles are a potential drug delivery method for poorly water-soluble drug delivery which can not only get impacted by formulation variables but also by process variables.

Journal of Pharmaceutical Research International

Influence of Process Variables on Budesonide Nanoparticles Using Factorial Design

Drug development plays an important role in patient safety and effectiveness. The therapeutic suitability of a new drug depends on the solubility. The solubility of the sparingly soluble drug remains a problem in identifying new active compounds. Solubility plays an important role in achieving optimal drug concentration. Low solubility is not only a concern for the production of formulations, but also an obstacle from the outset when identifying active chemicals for therapeutic purposes. Due to its simplicity in terms of ease of administration and economy, the oral route is the preferred route of drug administration over other routes. Effective aqueous solubility is the first prerequisite for oral medication, since low solubility has poor absorption and bioavailability and unpredictable toxicity of the gastrointestinal mucosa. To avoid these crises, different methodologies are used to improve the solubility and bioavailability of poorly soluble drugs and hydrotropic solubilization is one of them. Hydrotropic agents have the potential to improve the solubility of water-insoluble drugs. In this review, we try to address hydrotropic solubilization methodologies. Keywords: Hydrotropy, Micelles, Solubility, Formulation.

Journal of Drug Delivery and Therapeutics

Hydrotropic Solubilization: An Emerging Approach

IJPSR

SOLID DOSAGE FORM DEVELOPMENT OF DABIGATRAN ETEXILATE MESYLATE WITH INCREASED SOLUBILITY AND DISSOLUTION USING COCRYSTALLIZATION

International Journal of Recent Scientific Research

GELUCIRE: AN EMERGING POLYMER IN PHARMACEUTICALS

A simple, accurate, precise, specific and highly sensitive spectrophotometric method developed for the determination of Fluindione in bulk drug.The optimum conditions for the analysis of the drug were established. The $\lambda$ max of the Fluindione was found to be 230nm in 10% methanol in 0.1N HCL. The method shows high sensitivity with linearity 1 to 5$\mu$g/ml. The regression of the curve was Y = 0.097x + 0.1277.The apparent molar absorptivity was found to be 4.79 × 104 mol-1 cm-1 in 10 % Methanol. The lower limit of detection and the limit of quantitation was found to be 0.09302$\mu$g/ml and 0.28186$\mu$g/ml respectively. All the calibration curves shows a linear relationship between the absorbance and concentration and correlation coefficient was 0.999.The proposed method will be suitable for the analysis of Fluindione in bulk form.

Der Pharmacia Lettre

Development and validation of UV spectrophotometric method for fluindione

Quality by Design (QbD) refers to a new approach to product development that could increase efficiencies, provide regulatory relief and flexibility and offer important business benefits throughout the product life cycle. It supports both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. During designing and development of a product in QbD, a company needs to define desire product performance profile [Target Product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). The company then designs the product formulation and processes to meet the product attributes. This leads to understanding the impact of raw materials [Critical Material Attributes (CMA)], on the CQAs and identifies and control sources of variability. This systematic approach to product development and manufacturing has received a great deal from the traditional approach, which was extremely empirical. QbD is necessary in regulatory requirement and to implement new concepts such as design space, International Conference on Harmonization{\^{a}}s guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management and FDAs process analytical technology (PAT).