Hovione Launches ASD-HIPROS

The Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation

Amorphous Solid Dispersions formulation by Spray Drying ASDs | Hovione

Lisbon, Portugal, 12^th January 2021 – Hovione, the leader in Pharmaceutical Spray Drying, today announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions. This platform is the most advanced and most accurate tool to identify optimal and commercially viable Amorphous Solid Dispersions formulation by Spray Drying (ASDs). During drug development, it is crucial to quickly find the optimal formulation assuring fast progress to clinical supplies and minimal formulation changes till commercialization.

ASD-HIPROS, the Hovione Intelligent PROprietary Screening methodology, is able to rapidly screen for the best combination of polymers, drug loads, surfactants and solvents by using an advanced computational tool followed by producing scale-independent representative samples of the most promising formulations, which are evaluated for performance and stability.

“ASD-HIPROS is a multiple-step screening service that was perfected in the last 15 years and is able to provide an accurate assessment of Spray Dried Dispersion, in less than 2 months and requiring as little as 5-g of API.” commented Dr. Filipe Gaspar, Hovione’s Chief Technology Officer. “Our accumulated experience and expertise in Spray Drying were used for the development of this platform. It offers a rational formulation definition using a combination of in silico computational modelling and high throughput formulation testing, maximizing the chances of identifying a winning formulation based on outputs obtained from Spray Drying prototypes”.

“We offer a seamless experience, for our customers, and a secure path for their drugs to clinical supplies and commercialization, thanks to our unmatched experience, know-how and manufacturing capacity.” stated Dr. Jean-Luc Herbeaux, Hovione’s Chief Operating Officer.

About Hovione

Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.

Contact
Isabel Pina | Director External Communications
ipina@hovione.com |Tel.: 0035121 982 9362

Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process. Read the full article at gmp-journal.com

Article

GMP Journal, 04 March 2024

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024

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