Formulation

Unwanted materials that coexist with active pharmaceutical ingredients (APIs), surface during formulation, or become apparent after the formulation and API have run out are known as pharmaceutical impurities. The therapeutic properties of generic drugs may be affected, even in minute quantities, by the creation of these chemical pollutants. The pharmaceutical business is currently facing significant issues with impurity control. Researchers from the International Conference on Harmonization (ICH) have worked to manage pollutants. This review describes various impurity types, sources, and degrading transcription factors using specific examples.

  The objective of this study was to formulate and evaluate gastroretentive effervescent floating  matrix  tablet of two anti-asthmatic drugs, Salbutamol sulphate and Theophylline which are often indicated for the management of asthma, their frequent dosing may reduce compliance, thus making a prolonged release formulation necessary. Tablets were prepared by wet granulation method using Hydroxy propyl methylcellulose (HPMC) as a release retardant agent and sodium bicarbonate and Citric acid as a gas-generating agents. The prepared granules showed satisfactory flow properties and compressibility. Formulations were evaluated for in vitro drug release profile and swelling characteristics. The similarity factor and dissolution kinetics were used as parameters for selection of the best batch. The result of formulation C7 batch showed the best result and was found to extend the release of Salbutamol Sulphate and Theophylline upto 12 hr. and was found to be comparable with marketed sustained released tablet Theoasthalin SR (Cipla). The in- vitro drug release followed Korsemeyer-Peppas kinetics and the drug release mechanism was found to be of anomalous type i.e, swelling and diffusion.