Abstract
The particle shape, size and distribution of active pharmaceutical ingredients (API) are relevant quality indicators of pharmaceutical tablets due to their high impact on the manufacturing process. Furthermore, the bioavailability of the APIs from the dosage form depends largely on these characteristics. Routinely, particle size and shape are only analyzed in the powder form, without regard to the effect of the formulation procedure on the particle characteristics. The monitoring of these parameters improves the understanding of the process; therefore, higher quality and better control over the biopharmaceutical profile can be ensured. A new fiber-array-based Raman hyperspectral imaging technique is presented for direct simultaneous in-situ monitoring of three different active pharmaceutical ingredients- acetylsalicylic acid, acetaminophen and caffeine- in analgesic tablets. This novel method enables a chemically selective, noninvasive assessment of the distribution of the active ingredients down to 1 µm spatial resolution. The occurrence of spherical and needle-like particles, as well as agglomerations and the respective particle size ranges, were rapidly determined for two commercially available analgesic tablet types. Subtle differences were observed in comparison between these two tablets. Higher amounts of acetaminophen were visible, more needle-shaped and bigger acetylsalicylic acid particles, and a higher incidence of bigger agglomerations were found in one of the analgesic tablets.
Subject
Chemistry (miscellaneous),Analytical Chemistry,Organic Chemistry,Physical and Theoretical Chemistry,Molecular Medicine,Drug Discovery,Pharmaceutical Science
Reference68 articles.
1. Particle Size Specifications for Solid Oral Dosage Forms: A Regulatory Perspective;Sun;Am. Pharm. Rev.,2010
2. EFFECT OF PARTICLE SIZE ON ASPIRIN-INDUCED GASTROINTESTINAL BLEEDING
3. Drug Interactions Involving Aspirin (Acetylsalicylic Acid) and Salicylic Acid
4. Caffeine as an analgesic adjuvant for acute pain in adults
5. Chapter 905: Uniformity of dosage units
http://www.uspbpep.com/usp29/v29240/usp29nf24s0_c905.html, last accessed on 28.11.2019
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