DIGITAL ASSISTANT TO SUPPORT PRODUCT DEVELOPMENT

• Main Authors: Hees, Ulrike, Klug, Felix, Hebestreit, Johann Philipp, Cech, Thorsten, Orthofer, Andres Christian, Brandl, Ferdinand Paul, Sievert, Kai, Geiselhart, Verena, Burns, Brett R, Rueckold, Christian Herbert
• Format: Patent
• Language: English
• Published: 17.11.2022
• Subjects: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATIONTECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING ORPROCESSING OF MEDICAL OR HEALTHCARE DATA; INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTEDFOR SPECIFIC APPLICATION FIELDS; PHYSICS

In order to facilitate product development, such as pharmaceutical product development, a computer implemented method and an apparatus are proposed that enable formulators to develop robust drug formulations in a cost- and time-efficient manner. To start the development process, the user selects the preferred dosage form (e.g., granules, pellets, capsules, tablets etc.), defines a target profile (e.g., amount of active ingredient per unit, size of dosage form, mechanical strength of dosage form, desired release behaviour etc.) and enters key characteristics of the active ingredient (e.g., true density, particle size distribution data, bulk and tapped density, angle of repose, compressibility and compactibility profile etc.). The identity (e.g., chemical name or structure) of the active ingredient is not necessarily disclosed. The apparatus processes the provided data and calculates key parameters of the AI (e.g., particle size, powder density, powder flow and tabletability) Similar key parameters are calculated for common pharmaceutical excipients and stored in the apparatus. The apparatus then selects all relevant excipients and suggests a suitable manufacturing process. Combinations of active ingredients and excipients qualify as drug formulation if the predicted properties comply with the defined target profile. The following aspects can be considered: solubility and permeability of the active ingredient, dissolution of the active ingredient, probability to pass the content uniformity criteria, flowability of the powder blend, tabletability of the powder blend, mechanical strength and size of the tablet, compatibility of active ingredients and excipients etc.