A Standardization and Formulation study of Multi component tablet drug

Abstract

Background: According to WHO research, 3-5 million people are affected by the flu every year and 290-650 thousand people die. In case of clinical symptoms, anti-symptomatic treatment such as fever, headache, joint-muscle pain, stuffy nose, squinting, lacrimation etc. is performed along with treatment against the cause. Therefore, we are researching the technology of tablets that can replace imports made of quality guaranteed raw materials with a combination of acetaminophen, phenylephrine hydrochloride, and chlorpheniramine maleate, which relieves the pain and pathological symptoms of acute upper respiratory tract inflammation and colds. Aim: To develop and evaluate the quality of the technology of tablets with complex ingredients. Materials and Methods: One tablet is calculated to contain 325 mg of acetaminophen, 5 mg of phenylephrine hydrochloride, and 1 mg of chlorpheniramine maleate. Appropriate excipients were selected in different ratios, and 4 experimental tablets were obtained by wet granulation. The pre-formulation studies were determined according to the European Pharmacopoeia(EP-2015) methodology and tablets were formed by S250 automatic tabletting machine. The physical parameters and microbiological parameters of tablets were determined according to the requirements of tablets according to the Pharmacopoeia of China (CP-2020). The amount of the main active substance contained in the composition of tablets with a complex composition was determined by the method of high-performance liquid chromatography (HPLC). Results: The flowability and compressibility of test A3 and A4 tablets met the requirements of (EP-2015). By determining the content of the main active substance (A3) according to the method, it was found that the content of Acetaminophen mg/tablet 321.77±0.85, Phenylephrine hydrochloride, mg/tablet 5.03±0.01, and Chlorphenamine maleate, mg/tablet 2.18±0.03 were the most appropriate. determined. Conclusions: 1. It has been determined that it is suitable to produce tablets with a compound composition using the A3 formula and wet granulation method. 2. A3 model tablets with composite composition meet quality requirements in terms of appearance, average weight, durability, dissolution, content of active substances and microbiological parameters.