All aspects of the pharmaceutical industry are regulated by the highest standards of quality, safety, and reliability. Product formulations must consistently perform to these standards or patients, healthcare professionals, and pharmaceutical manufacturers could be put at considerable risk.
To ensure consistent product performance, active pharmaceutical ingredients (APIs) and excipients must behave in predictable and repeatable ways. Pharmaceutical particle size reduction is a major factor in determining and achieving desired substance behaviors, which points to the importance of both jet milling and your toll processing partner.
The obvious question to ask is if a toll processor has experience in jet milling for pharmaceutical particle size reduction. Gauging their acumen in the pharma space gives you insight into what they will be able to accomplish for you in terms of reduced particles.
Aligning with a toll processor with a firm understanding of how particle size impacts the solubility, permeability, and dissolution rate of pharmaceutical formulations is a solid first step. Widening your focus to find a toll processor with added practical experience in a breadth of drug delivery options — oral, parenteral, topical, transdermal, inhalation, etc. — increases the knowledge base. Now you’re working with experts in particle size range and distribution, which impact sedimentation rate, absorption, bioavailability, and more.
When a toll processor can back jet milling expertise with practical knowledge and experience in the pharmaceutical industry, they are a standout choice for helping you with pharmaceutical particle size reduction projects.
Custom Processing Services has this unique combination of attributes, and a proven track record with the pharmaceutical industry. Over the years we have identified ways that our jet milling services optimize pharmaceutical particle size reduction and benefit manufacturers in these 5 key ways:
Without moving parts in the grinding chamber, there is no wear and tear on the equipment that may introduce foreign matter, and the simplified mill design is easy to clean and sanitize. Contamination risk is negligible, and virtually eliminated with the extra measures taken for pharmaceutical particle size reduction, specifically clean room procedures, stainless steel equipment, and the use of purified/pressurized air during jet milling.
Further, CPS has a variety of smaller scale equipment that lends itself to in-house sample testing. Manufacturers can run tests on a small batch of raw materials to better understand behaviors and make adjustments prior to larger production runs, or use the testing to keep large-scale particle size reduction projects on track with targeted results.
Pharmaceutical manufacturers can’t take a lax approach to achieving product formulation goals — or to the toll processor they entrust with particle size reduction There is simply too much at stake.
Our guide, Milling Methods for Food and Pharmaceuticals, walks you through how to evaluate a toll processor as a potential fit for pharmaceutical particle size reduction projects, and explains the advantages of working with true milling experts. Click the button below to claim your copy of this valuable guide now.