Catalent

	Catalent has the broadest drug development toolkit, offering clients multiple technologies to enhance the bioavailability and solubility of drugs during formulation.

	Micronisation is a proven, dependable and versatile method to achieve high quality particle size reduction to assist in API and formulation optimisation. Catalent Micron Technologies is a global leader in particle size reduction services, delivering high quality micronisation, milling, and analytical services. Its full range of capabilities includes:

	   •   Development through to commercial scale
	   •   Micronisation (jet mill)
	   •   Mechanical milling (hammer mill, pin mill)
	   •   Cryogenic milling
	   •   Controlled handling of potent and cytotoxic compounds
	   •   Comprehensive supporting analytical services

	Spray drying can also assist in overcoming formulation and development challenges, and from its facility in San Diego, Catalent offers this service from early phase development through to clinical manufacturing scale. With over 75 years’ experience in spray drying and amorphous dispersion technology, the Pharmatek SD spray drying team can fully characterise an API and associated formulations throughout feasibility, development, and commercialisation, to provide a robust data package in support of regulatory filings.

	The Pharmatek SD spray drying technology offered by Catalent is integrated into its extended OptiForm Solution Suite platform, which allows drug developers to gain an insight into accelerating programmes from late-stage discovery to phase I trials.

Articles

Technologies for bioavailability and solubility enhancement

	Modern drugs are becoming more complex and often bring bioavailability and delivery challenges to formulation scientists. By tackling these challenges earlier in the process, and selecting an optimal dosage form at the clinical development stage, costly and time-consuming steps can be avoided later in development, and programmes can be accelerated through the clinic and on towards commercialisation.

	Catalent has a broad range of experience and expertise in early phase development, which has seen the company support over 500 INDs. From its facility in San Diego, Catalent supports early phase small molecule development, while its OptiForm® Solution Suite integrates tools and services to deliver relevant data and an optimised development programme; providing an efficient and seamless path from late-stage discovery to phase I clinical trials.

	Designed to make it easier and faster for small and mid-sized innovators to develop better treatments, OptiForm Solution Suite includes a comprehensive range of candidate screening tools, ADME considerations, and 

 DMPK modelling, as well as additional bioavailability enhancing tools to provide materials for cGLP toxicological studies, and on to first-in-human studies.

	Catalent. More products. Better treatments. Reliably supplied.

Catalent partners with innovators to accelerate programmes through the early phases of development, overcome a molecule’s solubility and bioavailability challenges, and increase its likelihood of success in the clinic.


Early drug formulation and development

From Candidate to Clinic: Strategies to Select, Assess, Formulate, and Deliver the Right Drug Candidate in the Early Phase

A Data-Driven Approach to Overcome Bioavailability Challenges

	Catalent is the leading global provider of advanced drug delivery technologies and development solutions for drugs, biologics, and consumer health products. The company has over 80 years’ experience serving the pharmaceutical industry, and proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable product supply.

	Catalent’s solutions include analytical, pre-formulation and formulation technologies and expertise, and with the recent addition of spray dry dispersion specialist Pharmatek, it now offers further early development capabilities and the most comprehensive toolkit of bioavailability enhancing technologies. Catalent produces over 70 billion oral, sterile, biologic, and inhaled doses each year, for clients across five continents.

	Built on its experience in early phase development, which has seen the company support more than 500 INDs, Catalent has extended the scope of its multi-award winning OptiForm

 Solution Suite. This integrates multiple tools and services to deliver customised development programmes that provide innovators with a data-driven, key milestone approach and a thorough analysis of important drug molecule characteristics at each stage, including consideration of downstream processing and optimal dose design for the intended patient group, to improve the chances of success in both the clinic and beyond.

Catalent has the broadest range of technologies and solutions to overcome developmental and bioavailability challenges, and to enhance product performance.

Broad Technology Toolkit to Accelerate Drug Development

	From early phase development through to clinical manufacturing scale, spray drying can assist in overcoming formulation and development challenges.

	With the acquisition of Pharmatek Laboratories, Catalent now offers spray drying as part of its bioavailability toolkit, complementing its comprehensive suite of development and formulation solutions. Additionally, the expansion of development and clinical manufacturing capabilities strengthens Catalent’s ability to partner with customers earlier in pre-clinical development.

	Pharmatek’s San Diego facility expands Catalent’s global network of clinical and commercial manufacturing supply facilities, which integrates drug development and delivery for both oral and injectable dose forms. The site has the capacity to provide rapid development from prototype to optimal final dose form, with integrated characterization, analytical, pre-formulation, formulation, process development, and cGMP manufacturing. The facility has over 18,000 square feet of laboratory, manufacturing and support space dedicated to development and manufacturing of highly-potent compounds.

	Spray drying technology will now be incorporated into OptiForm® Solution Suite, Catalent’s award-winning screening platform, to assess optimal formulation pathways for the oral delivery potential of both small and large molecule drugs.

With the acquisition of Pharmatek Laboratories, Catalent now offers spray drying as part of its bioavailability toolkit, complementing its comprehensive suite of development and formulation solutions.