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Systematic formulation design - shorten development cost & time Aurigene Pharmaceutical Services

Project Challenge: Existing formulation (lower strength - 50 mg) was manufactured using direct compression process.

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Systematic formulation design - shorten development cost & time Aurigene Pharmaceutical Services

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  1. Case Study Systematic formulation design - shorten development cost & time Customer: Medium sized pharmaceutical company Location: USA Indication: Treatment of severe plaque psoriasis Strength of product: 150 mg Dosage form: Tablet (Immediate release) Scope of work: Development and clinical supply for Phase II studies 1

  2. Project Challenge: • Existing formulation (lower strength - 50 mg) was manufactured using direct compression process. This formulation posed poor powder flow and content uniformity issues during scale-up. • Development of new strength 150 mg without any process issues was a challenge. Solution design: • Preliminary pre-formulation, stress study and PSD impact assessment enabled to understand the molecule nature • API Process engineering team helped to achieve appropriate particle size in a short span of time which was used for development • API being needle shaped posed problems when processed by DC process. Hence, new formulation of 150 mg was developed by wet granulation approach. • Robust process was developed within 2 months period such that same composition could be applicable for conducting dose ranging study without need for further formula or process optimization • The unique attribute of the developed formulation was that it could accommodate 50-200 mg of active ingredient without change in tablet weight. This enabled the customer to quickly fine-tune / finalize the dose based upon clinical study. • Activities included, QbD based risk assessment, PSD finalization, Stress studies on API and formulation to understand the drug nature, formula and process design and optimization • As the molecule is undergoing clinical trials, the developed formulation provides flexibility with respect to dose and advantage of cost/time which is otherwise needed for development of newer strengths ensuring continuous support for clinical trials Conclusion: • Formulation development and optimization within 2 months with deep scientific understanding and systematic approach. • DS-DP integration for on time delivery. • Flexible formulation design to accommodate different levels of API with aim of reducing time and cost of development of newly added strengths. 2

  3. Thank You For more information please visit https:/ /www.aurigeneservices.com/ To place an inquiry please visit https:/ /www.aurigeneservices.com/form/contact Mail us at contactapsl@aurigeneservices.com 3

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