Abstract

Solid dosage forms are the first choice of oral drugs because they allow a single and precise dose of the drug. The pharmaceutical industry as a whole is always developing ways to improve over traditional ways, with the aim of promoting the benefit, safety, acceptance, and adhesion of patients during therapy. Tablet coating refers to the application of a material over the outer surface of tablets, with the intention of providing greater stability and quality compared to uncoated tablets. Therefore, the main research proposal was to develop the coating for Valeriana officinalis L. tablets, to mask the unpleasant taste and odor of their cores, also acting to protect against moisture, which will disguise the differences in the appearance of the marketing tablets from a Quality-by-Design perspective. Polymeric coatings with different colors have been proposed to differentiate tablets at 50 and 100mg doses. Pharmacopoeial tests were conducted to define the most appropriate coating for the industry’s marketing sector. It was possible to obtain coated tablets with greater stability in relation to the cores, since the developed coating provided integral and uniform coverage, providing adequate differentiation of the 50 and 100mg tablets.

Keywords:Solid oral drugs; Polymer films; Pharmaceutical quality system; Hypnotics; Anxiolytic

Abbreviations:CC: Change Control; CMA: Critical Material Attributes; CPP: Critical Process Parameters; CQA: Critical Quality Attributes; FMECA: Failure Modes, Effects and Criticality Analysis; GMP: Good Manufacturing Practices; PCH: Product Change History; PEG: Polyethylene Glycol; PVA: Polyvinyl Alcohol; QbD: Quality-by-Design