Oral sustained release nystatin tablets for the treatment of oral candidiasis: formulation development and validation of UV spectrophotometric analytical methodology for content determination

Formulation development is an important part of drug design and development. Bioavailability and bioequivalence are totally dependent on formulation development. Now-a-days formulation development is done by following QbD (Quality by Design).The aim of present study is to formulate Gemfibrozil (Gem) sustained release (SR) and immediate release (IR) bilayer tablet by different concentration of Hydroxypropyl methylcellulose (HPMC) and HPMC K 100 M to control the release pattern. The sustained release layer of Gem was prepared by using different grades of HPMC like, HPMC K-15, HPMC K-4 along with other excipients by direct compression technique. The immediate release layer of Gem was prepared by Cross carmellose sodium, Crospovidone and Sodium starch glycolate by direct compression technique. The powders were evaluated for their flow properties and the finished tablets were evaluated for their physical parameters. The both immediate release and sustained release layers of Gem were characterized by FT-IR and in vitro dissolution studies. The drug release study of Gem was evaluated using USP-II paddle type dissolution apparatus. The release rate of Gem in immediate release layer was studied for 15 min in 0.1 N HCL media and that of Gem in sustained release layer was studied for 12 h in 0.1 N HCL. From the nine batches F6 batch showed good release behaviour 99.85% of drug is released over 12 hours. Gem belongs to BCS Class II (log P 3.6) with poor solubility and high permeability resulting in limited and variable bioavailability. Total four trial batches of each drug have been manufactured to optimize and develop a robust and stable formulation, the stability studies of the products also comply with ICH guideline. Keywords: Bilayer floating tablets, Gemfibrozil, Biphasic drug release, HPMC K 15.

Download Full-text

Formulation, Development and Evaluation of Sustained Release Gastroretentive Floating Tablets of Antidiabetic Drug using Natural Polymers

Asian Journal of Pharmaceutical Education and Research ◽

10.38164/ajper/9.4.2020.87-96 ◽

2020 ◽

Vol 9 (4) ◽

pp. 87-96

Author(s):

Aksah Chandak ◽

Sunil Kumar Shah ◽

Prabhakar Budholiya ◽

C. K. Tyagi

Keyword(s):

Sustained Release ◽

Natural Polymers ◽

Formulation Development ◽

Antidiabetic Drug ◽

Floating Tablets

Download Full-text

Analytical Method Development and Validation of Glipizide to Determine Residual solvents by head Space-Gas Chromatography

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.00429 ◽

2021 ◽

pp. 2440-2444

Author(s):

Sanapala Srinivasa Rao ◽

A. Vijayalakshmi

Keyword(s):

Gas Chromatography ◽

Method Development ◽

Limit Of Detection ◽

Dimethyl Formamide ◽

Analytical Methodology ◽

Residual Solvents ◽

Flame Ionization ◽

Ich Guidelines ◽

Method Development And Validation ◽

Development And Validation

Residual solvents in Pharmaceuticals are termed as organic volatile impurities. These are the chemicals that are used in the manufacture of drug substance or excipients or use in the preparation of final formulation. Most of the available methods use liquid chromatography which could be expensive and time consuming. Hence, an analytical methodology was developed for the quantification of residual solvents in Glipizide using a headspace gas chromatography (HSGC) with the help of flame ionization detector (FID). Methanol, acetone and dimethyl formamide as residual solvents were determined in Glipizide. Analysis was performed by headspace GC/FID method on Auto system- HS40. Nitrogen was used as a carrier gas and the separation of residual solvents was achieved by DB-Wax 0.25mm, 0.3mcm column. The thermostat temperature was 115 °C for 40 minutes for each vial. % RSD for nine injections obtained are in acceptance criteria. The correlation coefficient R2 obtained greater than 0.99. The method parameters were validated includes specificity, limit of detection and quantification, accuracy, linearity, precision, and robustness. According to the International Conference on Harmonization (ICH) guidelines, a new simple, specific, accurate and precise method was developed and validated.

Download Full-text