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Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations , such as milling , granulation , coating , tablet pressing , and others.
Since the 1999 publication of Good Manufacturing Practice for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ...
To uniquely meet this requirement, thin film formulations contain uniform dispersions of drug throughout the whole manufacturing process. [5] Since this criterion is essential for the quality of the thin film and final pharmaceutical dosage form, the use of Laser Scanning Confocal Microscopy (LSCM) was recommended to follow the manufacturing ...
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .
The dosage form for a pharmaceutical contains the active pharmaceutical ingredient, which is the drug substance itself, and excipients, which are the ingredients of the tablet, or the liquid in which the active agent is suspended, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients.
An excipient is a substance formulated alongside the active ingredient of a medication.They may be used to enhance the active ingredient’s therapeutic properties; to facilitate drug absorption; to reduce viscosity; to enhance solubility; to improve long-term stabilization (preventing denaturation and aggregation during the expected shelf life); or to add bulk to solid formulations that have ...
Sizing (size reduction, milling, crushing, grinding, pulverization) is an important step in the process of tablet manufacturing. In manufacturing of compressed tablets, the mixing or blending of several solid pharmaceutical ingredients is easier and more uniform if the ingredients are about the same size. This provides a greater uniformity of dose.
Mixed particle sized powders may separate during the manufacturing process due to differing particle densities. This can result in tablets with non-uniform concentrations of drug or active pharmaceutical ingredient (API), resulting in uneven dosage between tablets, but granulation should prevent this.