Philippe Tschopp’s Post

𝗔 𝘀𝘆𝘀𝘁𝗲𝗺𝗮𝘁𝗶𝗰 𝗰𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 𝗼𝗳 𝗳𝗼𝘂𝗿 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗽𝗼𝗲𝗶𝗮𝗹 𝗺𝗲𝘁𝗵𝗼𝗱𝘀 𝗳𝗼𝗿 𝗺𝗲𝗮𝘀𝘂𝗿𝗶𝗻𝗴 𝗽𝗼𝘄𝗱𝗲𝗿 𝗳𝗹𝗼𝘄𝗮𝗯𝗶𝗹𝗶𝘁𝘆 Powder flow is one of the crucial factors affecting several pharmaceutical manufacturing processes. Problems due to insufficient powder flow reduce production process efficiency and cause suboptimum product quality. The U.S. Pharmacopoeia has specified four methods to evaluate the flowability of pharmaceutical powders, including angle of repose (AoR), compressibility index (CI) and Hausner ratio (HR), Flow through an orifice, and shear cell. Comparison within and between those methods with 21 powders (covering a wide range of flowability) was performed in this study. #powderflow #pharmaceutical

Physical Properties Tests for Pharmaceutical Tablet Products In pharmaceutical tablet production, various physical tests are conducted to ensure consistent quality at each stage. These tests begin at the blend stage, continue with in-process checks, and finalize with finished product testing. In this Post I will talk about the Blend Stage. 1. Blend Stage At this stage, the quality of the powder blend is assessed before tablet compression. Key tests include: • Appearance and Visual Inspection: The powder is visually checked for uniformity in color, texture, and absence of foreign particles. This ensures the blend is free from contamination or inconsistencies that could affect tablet quality. • Moisture Content: Using a Moisture Analyzer, the moisture content of the powder blend is measured. Controlling moisture is essential to prevent degradation or improper compression of the tablets. The analyzer heats the sample and measures the weight loss, providing an accurate moisture reading. • Bulk and Tap Density: These tests determine the blend’s flow properties, ensuring consistent die filling during compression. Bulk density is measured without external force, while tap density is recorded after tapping the container to settle the powder.

Particle size reduction directly impacts pharmaceutical quality and performance. Are you working with the right toll processor?

Tablet hardness testing is crucial in pharmaceutical manufacturing to ensure the quality, consistency, and reliability of tablet products. This testing measures the mechanical strength of tablets, which directly impacts their ability to withstand handling, packaging, and transportation without breaking or crumbling. By ensuring tablets meet specified hardness levels, manufacturers can guarantee uniformity in drug release rates and effectiveness for patients. https://lnkd.in/gqHJcZqz

The #pharmaceutical industry aspires to go continuous but faces challenges due to the inability to feed the inherently poor-flowing nature of most pharmaceutical APIs. When handling more challenging materials, flow facilitation can be achieved using an agitator. However, the agitator can also negatively impact the feeding process. In a new article, Luz Naranjo Gómez from our team investigated the impact of screw-agitator speed ratio on the performance of pharmaceutical feeders using discrete element method and experimentally validated her findings. #ContinuousManufacturing #EquipmentDesign #Feeding https://lnkd.in/gFQ3hiUq

𝗖𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗥𝗲𝘃𝗶𝗲𝘄 𝗼𝗳 𝗠𝗼𝗱𝗲𝗿𝗻 𝗧𝗲𝗰𝗵𝗻𝗶𝗾𝘂𝗲𝘀 𝗼𝗳 𝗚𝗿𝗮𝗻𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗶𝗻 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗦𝗼𝗹𝗶𝗱 𝗗𝗼𝘀𝗮𝗴𝗲 𝗙𝗼𝗿𝗺𝘀 This comprehensive review explores modern granulation techniques in pharmaceutical dosage forms along with conventional methods, focusing on dry granulation and wet granulation. Dry granulation techniques, including slugging, roller compaction, and pneumatic dry granulation, are dissected with thorough analyses of their processing methods, advantages, disadvantages, and diverse applications. The article delves into eleven wet granulation techniques, offering insights into high-shear granulation, low-shear granulation, fluidized bed granulation, reverse wet granulation, steam granulation, moisture-activated dry granulation, melt granulation, freeze-dry granulation, foam granulation, thermal adhesion, and twin screw wet granulation. Each method is scrutinized, providing a comprehensive understanding of its processing steps, merits, drawbacks, and practical applications in pharmaceutical manufacturing. #pharmaceutical #granulation

This list covers a wide range of essential pharmaceutical calculations, which are critical for ensuring accurate formulation, process control, and quality assurance in pharmaceutical manufacturing. Here's a brief explanation of each type of calculation: 1. Batch Size Calculation https://lnkd.in/dg94etka 2. Potency or Assay Calculation of API https://lnkd.in/dr_Nm2fJ 3. Batch Yield Calculation https://lnkd.in/dMkBG6sM 4. Machine Capacity Calculation https://lnkd.in/dQR65-cr 5. Blender Occupancy Calculation https://lnkd.in/dirgzYys 6. Tip Speed Calculation https://lnkd.in/diAmdDcg 7. Dwell Time Calculation https://lnkd.in/d7vp-Bkv 8. Impurities Calculation https://lnkd.in/gC-irhTj 9. Mass Balance Calculation https://lnkd.in/dek92p22 10. Cleaning Validation Acceptance Criteria Calculation https://lnkd.in/d88Cq3Ee 11. Signal to Noise Ratio Calculation https://lnkd.in/dqFSQHCf 12. Peak to Vally Ratio Calculation https://lnkd.in/dtDnuc6j 13. Tailing Factor Calculation https://lnkd.in/dtBKT5yx 14. Retention Factor Calculation https://lnkd.in/d7ciHsJz 15. Peak Resolution Calculation https://lnkd.in/dSrRBxfW 16. Molarity and Normality Calculation https://lnkd.in/dayxzYN9 17. Milliequivalents and Millimoles Calculation https://lnkd.in/dXQwajTj 18. Molality and Mole Fraction Calculation https://lnkd.in/dt_2wtNg 19. Drug Dose Calculation https://lnkd.in/drg-_GUr 20. F1 & F2 Value Calculation https://lnkd.in/dpqrrTNb 21. Powder Flow Rate Calculation https://lnkd.in/dfhQMHyq 22. Powder Density Calculation https://lnkd.in/dNkSPjpQ 23. Loss on Drying Calculation https://lnkd.in/dcxFp6Rx 24. Process Capability Index Calculation https://lnkd.in/d2hAw7gD 25. Process Performance Calculation https://lnkd.in/decCHurC These calculations are foundational to maintaining product quality and regulatory compliance in the pharmaceutical industry.

Challenges With Content Uniformity of Pharmaceuticals I usually talk about dissolution testing in my posts, but there are many tests that need to be performed on our pharmaceutical samples. In my days in the pharma lab, I would perform moisture, assays, appearance, disintegration, and other tests to ensure that a product was fit for use. One of these tests of course was content uniformity. The content uniformity test is labor-intensive, and can take up quite a bit of time and glassware as well. Luckily, there is a newer approach to the older method which can speed up analysis greatly with less analyst time, greater precision, and better documentation. For a typical content uniformity test of a product, you would get 10-20 volumetric flasks and place a single dosage form in each one. This would then be topped off with a solvent and shaken, sonicated, or stirred until fully dissolved. A sample would then be taken from each of these flasks, and analyzed on UV or HPLC. Getting the results from these tests usually takes 1-2 days between the preparation and analysis. Analyst time is obviously significant, and we have to rely mostly on handwritten notebooks and labeling. The TRS100 is a unique Raman Spectroscopy instrument, which allows for the analysis of a product through the bulk of the product. The laser on this system is on the opposite side of the product as the detector - so we get to analyze a large portion of the product. That large sample being read means that you get a representative reading of the sample and you can also analyze lower concentrations than the standard Raman light scattering technique. With this instrument, you can analyze a sample in seconds - not hours. Everything is reported in the software too, so documentation is solid. Something I think is extra special about this technique is it is non-destructive. We can take these same samples and do dissolution on them once we are done. Now, we have more information about each of these samples giving us better confidence in those products. The TRS100 works for quality control, but it is also excellent for stability testing as well. If you'd like to know more, drop me a message or check out the TRS100 page here: https://lnkd.in/eQkgfy23 There are some webinars, application notes, etc. there for you to check out.

𝗧𝗵𝗲 𝗥𝗼𝗹𝗲 𝗼𝗳 𝗘𝘅𝗰𝗶𝗽𝗶𝗲𝗻𝘁𝘀 𝗶𝗻 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗣𝗼𝘄𝗱𝗲𝗿-𝘁𝗼-𝗧𝗮𝗯𝗹𝗲𝘁 𝗖𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 - See the article and PhD thesis from Pauline van der Wijst - Janssen The pharmaceutical industry is continuously looking for strategies and solutions that can improve quality and efficiency of manufacturing processes. As a result, there has been a significant shift towards continuous manufacturing (CM). Traditionally, tablets have been produced by batch processes, in which all ingredients are discharged in one unit operation. Production stops and material is removed after each processing step. In contrast, in a continuous process there are no discrete process steps and material is gradually moving through the different operating units. In spite of the increasing interest the pharmaceutical industry, CM is still new to many pharmaceutical companies. Much knowledge has been established on the role of raw material properties in batch processing, but this knowledge is not directly transferable to continuous processes. In order to enable the transition from batch production to continuous production, each processing step needs to be re-designed. The design of robust continuous processes requires a thorough understanding of the impact of material properties on each unit operation in a continuous manufacturing line. Continue reading here: https://lnkd.in/eD-6hWTS

New techniques for analysis of content uniformity.