Manufacturing and Analytical Services
ISSUE NO. 27 — The Complexities of Early-Phase Ophthalmic Drug Development
Ophthalmic medications have a particular set of challenges that can impact their speedy and successful path to market. From prototype formulation through preclinical testing, early-phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities. It is best to entrust drug development to a partner with regulatory knowledge, technical expertise, and a thorough understanding of the market in this growing therapeutic area. From current reality to future trends, being at the forefront of ophthalmic drug development delivers tangible benefits to sponsors.
In Issue 27 of The Altascientist, we dive into all areas of ophthalmic drug development, including:
- Prototype development, formulation, and manufacturing
- Preparing for first-in-human studies
- Species and strain selection parameters
- Routes of administration
- Specialized ocular assessments and equipment
- bioanalysis
- Phase I clinical research
- Phase II to commercialization
Three case studies are also included!
Test Your Knowledge of Liquid-Filled Capsules
Thanks to updated screening methods and bioavailability enhancements, poorly soluble molecules comprise 70% to 80% of the small molecule products entering the drug development pipeline today. Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution.
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. |