Manufacturing and Analytical Services
A Game-Changer for Poorly Soluble APIs
A Game-Changer for Poorly Soluble APIs
Fact: Over 70% of active pharmaceutical ingredients (APIs) entering the drug development pipeline are poorly water-soluble and thus, insufficiently bioavailable.
Nanomilling is one of the most effective proven techniques used to resolve solubility challenges and can be applied to almost any API with water solubility below 200 μg/mL. Benefits include particle size reduction, ease of scalability, reduced fed/fasted variability in both liquid and solid dosage forms, faster onset of therapeutic action, and low excipient side effects.
Learn more about our extensive expertise in nanomilling with a broad range of APIs, or speak with one of our formulation experts to find out how we can help.
Related resources that may interest you:
• Webpage: Global CDMO for Drug Manufacturing and Analytical Testing Services
• Scientific Journal: Nanomilling for Better Solubility and Enhanced Bioavailbility
• Webinar: The Development of Nanosuspension Formulations
Our Role in Treating Mental Health and CNS Disorders
Leading Partner in CNS Drug Development and Manufacturing
In honor of Mental Health Awareness month, we asked our CDMO Vice President and Scientific Advisor, Dennis DiBiagio, what specific expertise is required to manufacture drugs that treat central nervous system (CNS) disorders, including mental disabilities.
Watch our latest clip of Ask an Altascientist.
Speak with Dennis today about the unique and most advantageous reason drug sponsors choose to partner with us for their CNS drug development!
SEND DENNIS A MESSAGE
You may also be interested in these related resources:
• Webpage: Global CDMO for Manufacturing and Analytical Services
• Interview: Manufacturing of Highly Potent APIs and Controlled Substances
• Podcast: Key Considerations as You Move From Discovery to Preclinical to Clinical
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Scientific Journal on the Intricacies of CNS Drug Development
In this issue of The Altascientist, we detail the complexities of central nervous system (CNS) drug development programs. In addition, we share how partnering with an integrated CRO/CDMO can reduce your timelines by up to 40% as your compound advances through each study phase.
Topics covered include:
- Preclinical safety and toxicity testing
- Formulation and manufacturing for nonclinical and clinical studies
- Maximizing early phase clinical trials
- Bioanalytical considerations
Questions? Consult with our experts and tell us how we can support your program.
Related resources that may interest you:
- Podcast: High Potency Manufacturing Solutions
- Webinar: Practical Approaches When Conducting Clinical Trials With Psychedelics
- Educational Video: Development Strategies for Neurological Drugs
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Get Quicker Clinical Trial Data
Accelerate Your Clinical Trials with Liquid-Filled Capsules
Liquid-filled, two-piece capsules offer countless advantages over other solid dosage forms―ease of scalability and manufacturing, faster absorption, simpler packaging, and higher product stability, to name a few.
They are also the recommended dosage form for insoluble or highly potent APIs, and are known to accelerate product development because they can be made with fewer excipients than other solid dosage forms, such as tablets.
Discover the full benefits of using liquid-filled capsules in your clinical trials, or view this infographic for a quick tutorial.
Related Resources:
- Webpage: Contract Manufacturing and Analytical Solutions
- eBook: Applications of Liquid-Filled Capsules in Drug Development
- Webinar: Manufacturing Solutions Using Liquid-Filled Capsules
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Avoid These Mistakes During Formulation for Nonclinical Testing
Improve Your Odds of Success
Formulation development is a critical step that ensures the drug product is produced safely and effectively for use in nonclinical testing and, eventually, in clinical trials. Solubility, stability, route of administration, and dosage frequency are some of the factors assessed during formulation development.
In this podcast, our scientific experts discuss the everyday challenges encountered in formulation development for nonclinical testing, and tips to avoid or mitigate them to facilitate your IND application.
Do you need your API formulated and manufactured for nonclinical testing? Contact us today to get started!
Related Resources:
- Webpage: Contract Manufacturing and Analytical Solutions
- Interview: Complex and Customized Formulation Development
- Podcast: Key Considerations as You Move From Discovery to Preclinical to Clinical
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Case Study―Evaluating Milling Conditions for Scaling Up a Nanosuspension Drug Product
Mastering the Art of Formulation
Your Formulations, Brewed to Perfection.
Pharmaceutical formulation is one of the most critical steps in early phase drug development. The successful formulation of your active pharmaceutical ingredient (API) will ensure a smooth transition to preclinical testing and clinical trials, and eventually to market.
Our experts have vast experience formulating both simple and complex formulations, using techniques such as nanomilling to successfully formulate even the most challenging, insoluble, or highly potent APIs―ensuring you have your preclinical and clinical study material on time.
Here's a glimpse of our scientists working their magic!
Do you have an API that needs to be formulated? Contact us to get started.
Related Resources:
Ophthalmic End-to-End Drug Development Solutions
Tackling Formulation and Early Development Challenges of CNS Drugs
Avoid Roadblocks in CNS Drug Development
Development of drugs to treat central nervous system (CNS) disorders presents a unique set of challenges, including active pharmaceutical ingredients (APIs) with low solubility, poor bioavailability, or highly potent characteristics.
Altasciences is equipped to handle the formulation, as well as the preclinical, clinical, and commercial development of CNS drugs. Our FDA-registered and inspected cGMP manufacturing and analytical facilities are equipped with:
- DEA manufacturing and analytical license for drug Schedules I to V
- Segregated Grade C and D cleanrooms for the handling of highly potent APIs
- In-house R&D and formulation laboratories for drug product release and ICH stability testing
- Method development for low concentration formulations often used for psychedelics
- cGMP warehouse, including narcotic vaults and cold storage
Our scientific team has expertise with liquid-filled capsules, often the preferred dosage form for CNS drugs. We are also highly skilled in complex formulations and testing of controlled substances, including cannabidiols.
Get in touch to discuss how we can rapidly formulate and advance your CNS drug product to market.
Related Resources
- Webpage: Full Range of Manufacturing and Analytical Solutions
- Video: Handling of Highly Potent APIs and Controlled Substances
- Webpage: An Integrated Solution for Your First-In-Human Trials
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.