Manufacturing and Analytical Services
Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol
The Advantages of Liquid-Filled Capsules Over Tablets in All Phases of Drug Development
One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
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!
Benefits of Liquid-Filled Capsules in Pharmaceutical Development
Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
We are often asked about the advantages of working with an integrated CRO/CDMO.
2021 Year in Review
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In 2021, you did incredible things — and we are grateful to have been part of your journey. ISSUE NO. 21 — Terminal Sterilization of Pharmaceutical ProductsIn the human health field, injectable medications, ophthalmic preparations, irrigation fluids, dialysis solutions, sutures and ligatures, implants, and certain surgical dressings, as well as the instruments necessary for their use or administration, must be presented in a sterile condition. USP <797> states: “Medications that are required to be sterile include those administered through injection, intravenous infusion (IV), intraocular (injection in the eye) or intrathecal (injection in the spine).” There is a growing demand for sterilization of small-molecule parenteral products, including heart medications, eye drops, analgesics, and antibiotics, as well as common intravenous solutions such as glucose, potassium, and saline. Many such products are used by medical professionals in hospitals, and to ensure patient safety, the drug products and related instruments and materials are sterilized at manufacture. This ensures there are no microbial contaminants like fungi or bacteria present when the product is used. In Issue 21 of The Altascientist, we review:
Terminal Versus Aseptic Sterilization for Pharmaceutical ProductsGenerally, regulatory agencies such as the FDA, EMA, among others, prefer terminal sterilization over aseptic, as it provides a high level of sterility assurance. Psychedelics — Regulatory Environment Challenges
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A History of Public Attitude Towards Psychedelic DrugsPsychedelic drugs exist within a unique social, legal, and historical environment, with roots in the public imag Five Ways Altasciences Simplifies the Drug Development Process for You
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Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and costly process. |