The Critical Role of Particle Size and Shape in Active Pharmaceutical Ingredients and Excipients
Particle size and shape are critical in the pharmaceutical industry, impacting formulation, stability, and efficacy of drugs. They influence solubility, dissolution rate, and bioavailability. Advanced techniques like dynamic image analysis aid in developing and controlling safe, effective medications.
In the pharmaceutical industry, powdered active pharmaceutical ingredients (APIs) and excipients are crucial for drug formulation. APIs, the medications' active components, are often micronized to enhance dissolution and bioavailability. Many active ingredients are easily available on the market for various uses, such as acetylsalicylic acid, ibuprofen, and vitamins.
Excipients, on the other hand, are inactive ingredients that serve as the carrier for the API, facilitating delivery and stability. These powdered materials are meticulously formulated to ensure a final product with efficacy, safety, and patient compliance.
Particle size and shape are critical factors in pharmaceuticals, influencing dissolution behavior, which in turn affects bioavailability and efficacy. Table 1 describes the influence of particle size and shape on several crucial properties of pharmaceuticals. Overall, controlling particle shape is essential for the quality, efficacy, and manufacturability of pharmaceutical products.
In this application report, we examine commercially available pharmaceutical powders, namely ascorbic acid (vitamin C), ascorbic acid pellets with sustained release properties, and a blend of acerola extract and lactose powders, focusing on their particle size and morphology. Additionally, we analyze the dissolution behavior of the vitamin C powder.
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