Press Room

RDD Europe 2023

Start
Tuesday, May 02, 2023 - 09:00
End
Friday, May 05, 2023 - 17:06
Location: Antibes, France
Booth Number: Table #20
Drug Delivery Formulation | Hovione

Hovione will be exhibiting at RDD conference from May 2-5. Don’t miss the chance to speak with our experts in the Inspiring Dry Powder Inhalation Knowledge Space and learn how our development and manufacturing services for inhalation and nasal - integrated on a single site - can support in bringing your product to market.

 

Find us at the Blue Knowledge Space - Inspiring Dry Powder Inhalation - Table #20

 

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On May 3rd, don’t miss the joint workshop with Hovione and H&T Presspart 

 

Title - “Integrated Development for Capsule-based DPIs - Solving New Challenges”

Presenters: 

  • Susana Saldanha, M.Sc. - R&D Manager, Formulation Development, Hovione
  • João Pereira, M.Sc. - R&D Analytical Development,  Analytical Manager, Hovione
  • Mirjam Kobler Ph.D. -  Global Business Development Manager, H&T Presspart 

Abstract:

This workshop will address the most relevant aspects of DPI development covering formulation to device development, as well as process optimization and analytical characterization.  The most common challenges expected at each stage will also be highlighted. A data-based development approach will be applied using risk analysis and structured experimental design based on various case studies, for different development stages, including process optimization and scale-up activities. Starting with a review on the design and development of a highly efficient capsule-based device, the participants will further learn how to use tools to prepare and design development plans to achieve optimal performance from different formulation strategies to drug-device combinations. Case studies will be presented on the interplay of carrier-based and carrier-free formulations, with a newly designed device. The higher focus will be placed on the hurdles of composite particles formulation and process development as well as capsule filling of said challenging formulations.  Unit operations such as spray drying and capsule filling will be covered during this workshop.

 

On May 4th, don’t miss the POP Session – “Posters on the podium” with Patricia Henriques, M.Sc.

 

Title - Benchmarking of Particle Engineering Strategies for Nasal Powder Delivery: Characterization of Nasal Deposition using the Alberta Idealized Nasal Inlet

 

Abstract:

Powder formulations of a drug and mucoadhesive polymer have increased residence time in the nasal cavity and can be manufactured by blending, spray-drying or agglomeration of primary particles into chimeral agglomerates (CA). While spray-drying allows particle size control and generation of amorphous solid dispersions, blending is simpler and CA should allow faster dissolution after breakup into smaller particles. The objective of this study was to characterize nasal deposition and benchmark nasal powders manufactured by different particle engineering strategies, namely spray dried microparticles (SDM), CA and blends, using the Alberta Idealized Nasal Inlet (AINI). The AINI method conditions were firstly optimized by selecting appropriate angle of actuation and flow rate. Then, six different formulations prepared with distinct polymers and particle engineering strategies were evaluated.

 

On May 5th, don’t miss the Podium Presentation with Eunice Costa R&D Director, Inhalation & Advanced Drug Delivery 

 

Title - “Addressing challenges in high dose dry powder inhalation: formulation and device”

 

Abstract:

High dose delivery to the lungs is gaining momentum to address a diversified array of diseases being treated via respiratory drug delivery, comprising a range of drug classes, spanning from less potent small molecules to biologics. Dry Powder Inhalers (DPI) are the dosage form of choice for delivering high payloads to patients. Still there are opportunities for improvement in terms of ensuring that the formulation addresses the pharmacokinetics needs of the specific drug and indication, in close integration with the device, while ensuring delivery efficiency and safety. 
Herein, different high dose delivery platform approaches are discussed in terms of relative advantages and potential pitfalls, followed by some exemplary case-studies: from small molecules to biologics: development of high dose crystalline formulations and high dose spray dried proteins, as well as implementation of a DPI device suitable for cohesive high dose formulations. 
 

 

Two posters will also be presented:

  • Title - In Vitro Methodologies for the Screening of Nasal Powders: Polymer-based Formulations 
    Presenter: Patricia Henriques, M.Sc. – University of Coimbra, Hovione
     
  • Title - Expediting spray dried DPI formulation via the use of PAT
    Presenter: Maria Inês Lopes, M.Sc. – University of Lisbon, Hovione

 

 

Schedule a meeting with our team and get to know more about our unique range of particle engineering technologies for Inhalation & Nasal such as jet milling, wet milling and spray drying.

Let’s discuss your project together.

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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

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024