New API screening program strengthens Particle Sciences' nanomilling offering22 Jan 2019
Advanced formulation techniques such as nanomilling may provide an excellent route to improved bioavailability and enhanced therapeutic effect.
CDMO, Particle Sciences, a Lubrizol LifeSciences company, has strengthened its nanomilling offering with the launch of a new Nanomilling Feasibility Program.
The program is designed to assess nanomilling as a dissolution/solubility enhancement option for a client’s API. In as little as 8 weeks, Particle Sciences will nanomill an API with GRAS-approved excipients, measure particle size distribution, and obtain short-term stability data to identify promising formulations. Pre-clinical test samples will then made available to clients for pharmacokinetic studies.
Up to 90% of APIs in the discovery pipeline are poorly water-soluble, resulting in poor bioavailability and challenges for dosage form development. Nanomilling increases drug surface area, leading to an improved dissolution rate and, therefore, higher bioavailability for BCS class II and IV compounds. Nanomilling is commercially validated with 12 FDA-approved, nanomilled drug products since 2000, including Aristada and Invega Sustenna. Over the years, PSI has nanomilled scores of APIs, including new chemical entities as well as those found in marketed products.
Dr Robert Lee, president of Particle Sciences said: “With so many poorly water-soluble drug candidates emerging from drug discovery, advanced formulation techniques such as nanomilling are increasingly in demand and may provide an excellent route to improved bioavailability and enhanced therapeutic effect. While several companies now have nanomilling equipment, few have the extensive knowledge on stabilizing nanoparticulate suspensions and the analytical capabilities that we do. We are also the only CDMO that offers cGMP nanomilling under aseptic conditions.”
Particle Sciences has decades of experience developing nanoparticulate suspensions, both with commercial milling equipment and its own proprietary mills. The CDMO has the facilities and equipment to produce clinical and commercial-scale nanomilled formulations.
Dr Lee continued: “Our expertise in this area means we can determine within a short timeframe if nanomilling is a viable technology to improve the solubility of a client’s API and facilitate the decision-making process for their project.”
RAPS on delayed Brexit
26 Mar 2019
The post-Brexit regulatory environment continues to weigh heavily on the minds of regulatory professionals.Read more
Sizeable growth potential for global drug delivery and packaging in 2019
19 Mar 2019
Patient-centricity, eco-friendly and smart packaging trends marked as the biggest growth drivers and innovations in 2019.Read more
'Tamper-evident' benefits are evident
28 Feb 2019
2019 will mark Uniplast's debut at this year's edition of CPhI Worlwide in Frankfurt, where it will showcase its expertise in plastic packaging.Read more
All Recipharm facilities ready for EU serialisation, regardless of Brexit
15 Feb 2019
The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.Read more
Brexit - the EU FMD's painful problem
7 Feb 2019
Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.Read more
Pharmapack report predicts diversification of innovation leading to a rise in licensing and partnering
27 Jan 2019
New report highlights Germany, France and Switzerland as tier-one nations for ‘drug delivery innovation’, and warns the challenge will be to scale-up and approve promising prototypes.Read more
Univercells introduces breakthrough vaccine manufacturing platform
13 Jan 2019
The automated NevoLine bioproduction system that facilitates safer, faster and closed bioprocessing in a much smaller footprint.Read more
BMS and Celgene merge to create premier innovative biopharma company
3 Jan 2019
Significantly expands Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential.Read more
An increased risk of a hard or ‘no deal Brexit?
24 Dec 2018
A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.Read more
One month on: medical cannabis is still taboo despite change in law
11 Dec 2018
Restrictive guidelines have led many to buy CBD products online, leading to a boom in production with many products going to market without sufficient quality control.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation