Background: Excipients are used in the formulation of pharmaceutical dosage forms, but mayinteract with active pharmaceutical ingredients (APIs). Some of these interactions could alterthe physicochemical properties of the APIs which can affect the therapeutic efficacy and safety.Acarbose is an anti-diabetic drug used in this study as an API to investigate its compatibility withcommon excipients in order to development of pharmaceutical controlled release formulations. Methods: For this purpose, 15 different excipients were selected. Binary mixtures of drug witheach of the excipients (1:1 mass ratio) were prepared. Mixtures were analyzed immediately aftermixing and also after incubation at stress conditions (adding 20% water and incubated at 40°Cfor 2 months). The thermal analytical investigation like differential scanning calorimetry (DSC),Fourier transform infra-red spectroscopy (FTIR) and high-performance liquid chromatography(HPLC) were employed for physicochemical evaluations of the possible incompatibility.Photodiode-array (PDA) and mass studies were performed to ensure the peak purity of theHPLC peaks of API in stressed samples. Results: Incompatible excipients with acarbose were determined as EC (ethyl cellulose),Carbopol 934, Hydroxypropyl cellulose, PEG2000 (Polyethylene Glycol 2000), Mg Stearate, NaAlginate and Poloxamer. Conclusion: Results of this study would be used for the development of controlled releaseformulation of acarbose. It is recommended to avoid the use of incompatible excipients.
Pharmaceutical products are classified into two groups according to the microbiological point of view: 1) sterile products and 2) non-sterile products. The sterilized term refers to the products that are free of any microorganisms. Their production is done under aseptic conditions, but the production of non-sterile products is not under aseptic conditions and therefore, they are not free of microorganisms; for this type of products legal authorities defined microbial limit ranges. The contamination of medicinal products by microorganisms can lead to adverse changes such as: change in physical attribute (appearance, color, smell, and viscosity), reduction of therapeutic effects, development of disease and ultimately the loss of consumer reliance. There have been reports about presence of unauthorized microorganisms in non-sterile medicinal products, which has led to more research and attention in this regard. In this paper, the methods for controlling the microbial quality of non-sterile drug products have been reviewed based on the latest version of United States Pharmacopoeia (USP), including <61>, <62>, and <1111> general chapters that can be used as a reliable source for researchers in the pharmacy industry and drug control labs.
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