One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
Multiplexed Cytokine Comparison Across Two Species Dosed with the Same Drug
Establishment of Historical Control Reference Values of Cambodian Cynomolgus Macaque Blood Gases
Detection of Plasma Cells and their Precursors in Bone Marrow and Peripheral Blood
Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes
Up Close and Personal with Dr. Simone Iwabe, DVM, PhD, DACVO
Meet Dr. Simone Iwabe, DVM, PhD, DACVO
Senior Veterinary Ophthalmologist
Three Key Advantages of Conducting Early-Phase Clinical Trials in North America: An Overview of the Webinar “A Hop Across the Pond”
Regulatory processes can be challenging, and potential solutions can be found in broadening your focus to include clinical sites in the U.S. and Canada for your drug development strategy. With an understanding of how regulatory agencies and market environments may differ, you will be in a better position to optimize your program. In Altasciences’ on-demand webinar, A Hop Across the Pond, Ingrid Holmes, Vice President of Global Clinical Operations, and Dr.
Test Your Preclinical Toxicology Knowledge
In drug development, toxicology evaluates and examines adverse effects of an investigational product on a living organism to determine its initial safety and dose-specific effects. But did you know that toxicology is not limited to drug development? Toxicology is a branch of science that deals with toxins and poisons, and their effects and treatment; other types of toxicology include forensic toxicology, environmental toxicology, food toxicology, and veterinary toxicology.
Take this quiz to discover how much you know (or don’t know) about toxicology.
Current Trends in Drug Development
The drug development landscape has been evolving over the years, from an earlier emphasis on blockbuster drugs developed in-house by large pharmaceutical companies, t
ISSUE NO. 22 — Nanomilling for Better Solubility and Improved Bioavailability
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.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
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