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কোম্পানি মামলা সম্বন্ধে A Pharmaceutical Manufacturer Improves Drug Emulsion Bioavailability with an Industrial Homogenizer

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A Pharmaceutical Manufacturer Improves Drug Emulsion Bioavailability with an Industrial Homogenizer

2025-11-07

A Pharmaceutical Manufacturer Improves Drug Emulsion Bioavailability with an Industrial Homogenizer​
 
Background​
 
A mid-sized pharmaceutical company in Asia specialized in oral drug emulsions (used to treat pediatric digestive disorders). Their existing production line used a low-shear mixer, which produced drug droplets with an average size of 5–8 μm. Clinical tests showed that these large droplets had low bioavailability—only 45% of the drug was absorbed by the body—requiring patients to take higher doses (increasing the risk of side effects).​
Challenge​
The company needed to: 1) Reduce drug droplet size to ≤ 2 μm to improve bioavailability; 2) Ensure consistent droplet size across large production batches (500L per batch) to meet regulatory standards (e.g., FDA and NMPA requirements); 3) Integrate the new equipment into their existing production line without disrupting daily operations.​
Solution​
The company adopted an industrial high-pressure homogenizer (max pressure: 1,500 bar) with a multi-stage homogenizing valve. The device included a built-in particle size analyzer (to monitor droplet size in real time) and a sanitary design (316L stainless steel, meets GMP standards) for pharmaceutical production.​
Implementation & Results​
  • Production Process: The drug mixture (oil, water, and active pharmaceutical ingredient) was pre-mixed in a tank, then pumped into the high-pressure homogenizer. The mixture passed through 3 stages of valves, where high pressure sheared the droplets into smaller sizes. The real-time particle analyzer adjusted pressure automatically to maintain droplet size at 1.2–1.8 μm.​
  • Outcomes:​
  1. Average drug droplet size was reduced to 1.5 μm, increasing bioavailability to 72% (verified by third-party clinical tests). This allowed the company to lower the recommended dose by 38%, reducing the risk of side effects.​
  1. Batch-to-batch variation in droplet size was reduced from ±1.5 μm to ±0.3 μm, fully complying with global regulatory standards.​
  1. The homogenizer was integrated into the existing line within 1 week (with minimal downtime), and production efficiency remained unchanged (1 batch per 4 hours).​
  • Business Impact: The improved drug formulation received regulatory approval in 3 countries within 6 months. Patient compliance rates increased by 25% (due to lower doses), and the company’s market share in pediatric pharmaceuticals grew by 12% in the first year.