Conte, Elisa

Crafts, Peter A.

Gani, Rafiqul

Sansonetti, Sascha

Online Research Database In Technology

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Downloaded from orbit.dtu.dk on: Dec 19, 2017Rational Design of Pharmaceutical and Other Liquid FormulationsConte, Elisa; Sansonetti, Sascha; Crafts, Peter A.; Gani, RafiqulPublication date:2011Link back to DTU OrbitCitation (APA):Conte, E., Sansonetti, S., Crafts, P. A., & Gani, R. (2011). Rational Design of Pharmaceutical and Other LiquidFormulations. Abstract from 2011 AIChE Annual Meeting, Minneapolis, MN, United States.Abstract: Rational Design of Pharmaceutical and Other Liquid Formulations (2011 Annual Meeting)http://aiche.confex.com/aiche/2011/webprogram/Paper221400.html[28-10-2011 15:56:21]Start | Grid View | Browse by Day OR Group/Topical | Author Index | Keyword Index | Personal SchedulerRational Design of Pharmaceutical and Other Liquid FormulationsWednesday, October 19, 2011: 10:15 AM102 A (Minneapolis Convention Center)Elisa Conte1, Sascha Sansonetti1, Peter A. Crafts2 and Rafiqul Gani1, (1)CAPEC, Department of Chemical and BiochemicalEngineering, Denmark Technical University (DTU), Kgs. Lyngby, Denmark, (2)Process R&D, AstraZeneca Pharmaceuticals Ltd.,Cheshire, United KingdomEvery year pharmaceutical, health-care and related industries invest a high percentage of their total time and resources ondevelopment of new products and improvement of existing (pharmaceutical) formulations. Product development is still mainlybased on trial and error experimentation and laboratory procedures, indicating long research processes without any certainty of adefinitive solution and far from achieving the optimal formulation of the product. Besides, (pharmaceutical) ingredients to be usedfor the experimentations are often very expensive and not available in the desired form or at the desired level of purity. Moreover,the experimental procedures are affected by unavoidable errors due to the complicated and often not-standardized procedures.Therefore, the need for a rational and systematic model-based approach to plan suitable experimental designs would constitute afairly useful tool for pharmaceutical product design and product design in general. A model-based approach significantly reducesthe number of experiments necessary for product design and at the same time gives a clear idea about the direction to take forfurther (reduced) experimentation. In such a way tedious and uncertain screening processes can be avoided with sensiblereduction of both time and resources for the product launch on the market.Identification of a pure solvent or anti-solvent for a specific Active (Pharmaceutical) Ingredient (API or AI) is a problem of majorconcern for the pharmaceutical and related R&D departments. Solvents, lipids and other compounds are commonly employed inproduct formulations as well as in API processing. In addition, the screening of several solvent mixtures that sometimes showimproved characteristics of solubility toward a particular API is necessary. Besides, in liquid formulated products, API (or AI) needsto be mixed with additives to enhance the product quality and solvents to deliver the product.This work presents a model-based method for solvent screening and solvent mixture design for pharmaceutical applications andAPI/AI based liquid formulated products. Two cases are investigated: a case where the solvent or solvent blend is designed for APIprocessing (here the solvent is not part of the final API based product), and a case where the solvent or solvent blend is part of theAPI/AI based formulated product. In both cases, the solubility of the API/AI needs to be predicted in solvents (single solvent orblends). A general solubility modelling procedure having different options for the solubility calculation (such as UNIFAC, UNI-sacand PC-SAFT) is employed. A unique feature of this solubility calculation procedure is that it is truly predictive and does not needany new experimental data for the computer-aided design stage of the formulation design methodology (Conte et al. 2011).Oncethe domain search has been reduced to a few solvents or solvent mixtures, solubility can be computed by correlative models suchas NRTL-SAC andPC-SAFT.The newly developed method described above is to be integrated in a comprehensive framework for formulation design that waspreviously developed and tested for personal care products. Such a method was implemented in the software ‘the virtual product-process design laboratory’ (vPPD-lab) (Conte et al., 2011).Examples illustrating the application of the procedure for solvent, solvent-blend and/or AI-based formulation design will bepresented. Also, a conceptual case study validating the models and the design steps involving the design of a solvent mixture thatmaximizes the API solubility as well as the identification of an optimal anti-solvent for a well-known API such as paracetamol willbe presented.ReferencesConte E, Gani R, Ng K M, Design of formulated products: A systematic methodology, AIChE J, 2011 (DOI 10.1002/aic.12458)Conte E, Gani R, Cheng Y S, Ng K, M, Design of formulated products: Experimental component, AIChE J, 2011 (DOI10.1002/aic.12582)Abstract: Rational Design of Pharmaceutical and Other Liquid Formulations (2011 Annual Meeting)http://aiche.confex.com/aiche/2011/webprogram/Paper221400.html[28-10-2011 15:56:21]Extended Abstract: File Not UploadedSee more of this Session: Innovation In Consumer Product Management and DesignSee more of this Group/Topical: Management Division

Rational Design of Pharmaceutical and Other Liquid Formulations

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Rational Design of Pharmaceutical and Other Liquid Formulations

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