New Methods for optimizing formulations and processes in fine chemistry and biotechnology

An innovative process that provides valuable information and radically increase preformulation, formulation and manufacturing cost efficiencies in biotechnology, pharmaceutical, food and cosmetics industries.

Introduction :

The development of new products (e.g. active pharmaceutical products/dosage forms) necessitates intensive research during the preformulation phase, the control of the manufacturing process and the implementation of the final formulation for optimal storage conditions.

The department of Formulation and Pharmaceutical Engineering led by Professor Aziz Bakri has thirty years experience in the field of galenic chemistry. It has developed a methodology together with a highly sensitive  analytic device that can adapt specifically to the study that is being carried out. The sample thermal activity trace (TAT) is detected and recorded under precise controlled vapor pressure. This approach allows the implementation of physical, (bio)-chemical or biological studies concerning stability, compatibility, ingredient interactions, studies, and population growth experiments. It provides precise results within a short timeframe.

Professor Bakri's team can offer its expertise in all of the following areas:

• Trouble-shooting and resolution of issues relating to product development, manufacture and storage
• API-Cyclodextrines inclusions, API-proteins/Polymer binding, Antigen-antibody interaction studies etc.
• Effect of xenobiotics upon Inhibition/stimulation of cell/ growth evaluation.
• (Bio) reactor optimization
• Consultancy relating to the choice of formulation and implementation processes
• Training sessions relevant to the field of formulation and thermal methods

Applications

This novel approach helps to solve various problems encountered during the development and processing of a new dosage form, cosmetic or food supplement. At the pre-formulation stage, the method will assess common physical and chemical compatibilities and stability issues and allow interaction studies between active product-excipient, protein-ligand and active product-cyclodextrines inclusions in order to fully optimize the formulation and manufacturing process.

Furthermore, other issues such as water activity, water content assessment in complex media, amorphous crystallization and quantification, polymorphism and product aging can be studied.

The system provides solutions to production problems when issues arise regarding process control, scale up (granulation, micronization, freeze/spay-drying...) or handling/storage conditions (temperature/vapor pressure).

Benefits

• Speed of analysis

The technique provides rapid and highly reliable results within hours as opposed to several weeks or even months usually required for conventional methods.

• Purpose-built equipment

The research laboratory has developed purpose-built equipment which enables the resolution of different problems relating to, for example, vapor-powder interaction and their consequences upon the physical stability of amorphous products (Patent N.Khalef and Bakri A., device and process for crystallization control n° 08/06918).

The GPCD-IDTC approach was presented at the annual meeting of the royal academy of chemistry (BAKRI, A)

• No treatment required

The third key benefit of the approach relates to fact that the method is non invasive and the product does not need to be treated prior to testing.

Potential Applications

The method is highly applicable to pharmaceutical, food or cosmetic industries, fine chemistry and for the characterization of new materials, vapor diffusion, polymer hydration/swelling/reticulation as well as in biotechnology for evaluating interactions in complex media (liposome, vaccine formulations) antigen-antibody interactions. Cell growth under precise controlled atmosphere environments, effect of growth stimulants (hormones etc) and inhibitors (antibiotics, anticancer drugs etc) and bioreactors optimization with the benefit of enumerating only alive and active cells by tracing metabolic heat .

- Khalef N. and Bakri A., Recent Methods for stability and compatibility studies in pharmaceutical preformulation, STP Pharma, volume, 2005 (15), 342-353.- BHUGRA C., S. RAMBHATLA , A. BAKRI , S.P DUDDU , AND D. P MILLER , M.J Pikal , D.Lechuga-Ballesteros, Prediction of the onset of crystallization of amorphous sucrose below the calorimetric glass transition temperature from correlations with mobility, J Pharm Sci. 2007, (5),1258-1269.
- Khalef N., Bakri A., Contributions méthodologiques et instrumentales aux études d'interaction solide-vapeur et transformations cristallines induites en recherche et développement pharmaceutique, Récents Progrès en Génie des Procédés, Numéro 97 - 2008, ISBN 2-910239-71-3, Ed. SFGP, Paris, France.
- Khalef N., Bakri A., Etude comparative de cristallisation par calorimétrie isotherme en système ouvert et en système fermé et détermination de faibles taux d'amorphe, Récents Progrès en Génie des Procédés, Numéro 97 - 2008, ISBN 2-910239-71-3, Ed. SFGP, Paris, France.
- Khalef N., Bakri A., Caractérisation des matériaux par un système calorimétrique isotherme double jumeau ouvert : mesures des énergies de surface, établissement des isothermes de sorption et études des phénomènes de recristallisation d'amorphes, Récents Progrès en Génie des Procédés, Numéro 97 - 2008, ISBN 2-910239-71-3, Ed. SFGP, Paris, France.
- Khalef N., Bakri A, Etude des interactions saccharose - humidité : optimisation des conditions de stockage des lyophilisats et nébulisats pharmaceutiques, Récents Progrès en Génie des Procédés, Numéro 97 - 2008, ISBN 2-910239-71-3, Ed. SFGP, Paris, France.
- Khalef N., D.Avignant, F.Pilotaz Bakri A., Etude de la stabilité physique et de la recristallisation du cromoglycate de sodium en solution et à l'état solide, Récent progrès en Génie des Procédés, Numéro 97 - 2008, ISBN 2-910239-71-3, Ed. SFGP, Paris, France.
- Khalef N., Hammad T., Bakri A., Optimisation de la stabilité chimique et physique de formulations solides de la benzocaïne par enrobage moléculaire et cristallisation, Récents Progrès en Génie des Procédés, Numéro 97 - 2008, ISBN 2-910239-71-3, Ed. SFGP, Paris, France.

Contacts
Véronique Sendra
+33 (0)4 76 00 78 30
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