ISSUE NO. 22 — Nanomilling for Better Solubility and Improved Bioavailability

Download Issue 22 of The Altascientist to read about nanomilling.

A crucial feature of drug development is bioavailability, defined as “the ability of a drug to be absorbed and used by the body.” For a drug to be bioavailable, it must first be soluble, meaning able to be dissolved, especially in water. Many drugs on the market today are poorly water soluble, and patent extensions or 505(b)(2) new patents become possible for formulation improvements delivered via nanomilling.

In Issue 22 of The Altascientist, we review:

solubility classifications
overcoming solubility challenges
the benefits of nanomilling
how nanomilling works
maximizing formulation

Case study included!

Overcoming Solubility Challenges With Nanomilling

Promising therapeutic molecules, even if classified as poorly soluble, can be developed successfully. There are multiple technologies available to increase the solubility and oral bioavailability of poorly soluble molecules being developed as active pharmaceutical ingredients (APIs) by reducing their particle size.

Nanomilling is a universal technique that can be applied to almost any API with water solubility below 200 μg/mL. It is a very adaptable drug delivery platform suitable for oral, injectable, inhalable, and buccal applications, for which fine drug particulates are especially desired in formulations.

Nanomilling is a unit operation where mechanical energy is applied to physically break down coarse particles to finer ones. It has wide commercial and industrial applications, as every drug can be ground to finer particles, whether aqueous or non-aqueous soluble. Decreasing the size of the API molecule increases the size of the specific surface area; the larger surface area allows for greater contact with water, increasing the API’s dissolution rate and bioavailability.

The Benefits of Nanomilling

Benefits of particle size reduction for the parenteral route include small dose volumes (resulting from high drug loading) and avoidance of harsh solvents and/or extreme pH conditions. Advantages for the pulmonary route include the ability to use inhalers intended for solutions, as well as the ability to produce spray-dried powders whose particle sizes are optimized for deep lung delivery.

Other advantages include reduced fed/fasted variability in both liquid and solid dosage forms, faster onset of therapeutic action, low excipient side effects, and the ability to run continuously.

How Altasciences Can Help Improve Your Drug’s Bioavailability With Nanomilling

Nanomilling is a highly complex process requiring a unique level of CDMO expertise that can only be gained through extensive experience with developing a broad range of APIs.

At Altasciences, we can take your API from formulation to commercialization. We have the necessary procedures, equipment, and experience to work with any formulation. Our highly skilled teams work with the latest equipment, including the NETZSCH DeltaVita® 15-300 mill, that with our wet milling options can reduce particles to nanometer size, fill vials in a range of sizes (from 0.3 ml to 500 ml), and package them.

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The Canadian Business Quarterly: Altasciences — Fully Integrated Problem-Solving Solutions

Contract Pharma: Altasciences Names Wendell Davis VP, Pathology

Dr. Wendell P. Davis Joins Altasciences as Vice President, Pathology

Laval, Quebec, February 7, 2022 – Altasciences announced today the appointment of Dr. Wendell P. Davis, D.V.M., Dipl. ACVP, as Vice President, Pathology, effective February 7, 2022.

Dr. Davis is a nonclinical development professional with extensive experience in toxicologic pathology and a proven track record of building and leading high functioning pathology groups in both the biotechnology and CRO sectors. He is a proven leader with a passion for building pathology capabilities and mentoring pathologists, research, and laboratory scientists.

As a study pathologist and peer reviewer, he has experience evaluating small molecules, biologics, oligonucleotide, and an array of RNA therapeutics modalities across a range of preclinical species and routes of administration, in support of both early candidate selection and regulatory filings.

Dr. Davis has also maintained an active role in the industry as a member of the Society of Toxicologic Pathology and as a diplomat member of the American College of Veterinary Pathologists.

“Wendell’s track record and leadership experience in the fields of anatomical pathology, discovery toxicology, and toxicologic pathology, as well as his ability to mitigate challenging toxicologic pathology issues will make him a great addition to our team, and deliver expert guidance for our clients,” said Mike Broadhurst, General Manager, Preclinical Services, at Altasciences.

Altasciences has strategically located preclinical research facilities in Seattle, Scranton, and Columbia, U.S.A. With over 25 years of experience conducting safety assessment, Altasciences offers a full range of in vivo GLP and non-GLP preclinical studies in multiple species to thoroughly assess the safety profile of molecules.

About Altasciences

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com

ghp Technology Awards 2021: Altasciences Named Best Pharmaceutical & Biotechnology Research Organisation 2021

Five General Knowledge Questions That You Probably Don’t Know the Answer To

They say a good scientist requires curiosity, first and foremost. When we are not hard at work, Altascientists (as we like to call ourselves) spend a lot of time questioning things that make you go hmm.

Here are a few examples…

Contract Pharma: Altasciences and Virpax Pharmaceuticals Enter Clinical Trial Partnership

Altasciences Chosen by Virpax Pharmaceuticals, Inc. to Conduct First-in-Human Study of Epoladerm™ for Chronic Pain Associated with Osteoarthritis of the Knee

Laval, Quebec, January 21, 2021 – Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) to conduct a first-in-human study of Epoladerm™ (diclofenac epolamine) for chronic pain associated with osteoarthritis of the knee. This treatment is supplied in a pre-filled device for administration as a topical spray film.

The study will be conducted in Q2 2022 at Altasciences’ clinical pharmacology unit in Montreal, Canada. “We look forward to working with Altasciences to accelerate the development of this analgesic treatment and provide robust data in support of the 505(b)(2) FDA approval pathway,” stated Virpax’s Chairman & CEO, Anthony P. Mack.

Virpax’s proprietary technology provides a pre-filled canister for the therapeutic application of a clear, fast-drying spray film that is thinner than a standard liquid bandage. This technology offers convenience and eliminates the need for messy creams or gels.

Altasciences leverages decades of experience conducting first-in-human clinical trials, a vast database of study participants, and state-of-the-art bioanalytical facilities to provide expert guidance and personalized solutions. Ingrid Holmes, Altasciences’ Vice President, Global Clinical Operations, says, “We are proud to partner with Virpax to help move this important therapeutic further along the path to regulatory approval.”

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single service or a synchronized approach to CRO and CDMO services, from lead candidate selection to clinical proof of concept, and beyond.

More information on Virpax Pharmaceuticals, Inc.’s program can be found here.

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