Pre-Formulation
Pre-formulation (solubility and compatibility) provides an essential foundation for formulation development. Our efficient and agile quantitative R&D approach generates solubility and compatibility profiles with key ingredients. This data enables rational excipient selection and formulation design in terms of API solubility, stability and skin delivery while providing appropriate tolerance and sensory elements thereby securing fast and efficient formulation development. Forced degradation screening supports identification of optimal formulation conditions (e.g. preferred pH) and provides indications for use of additional stabilizers e.g. antioxidants. This critical activity is performed in close collaboration with our colleagues from chemistry and analytics.
Formulation And Process Development
Well-defined solubility and compatibility profiles enable NUVISAN’s experts to rapidly select optimal formulation technologies from our technology library and create new compositions ad hoc. Our expertise enables adaptation of our compositions to fit the individualized needs of to your molecule’s physicochemistry while rapidly advancing the project. Depending on your preference and your molecule, end-to-end development with a commercialized formula or exploratory formulas can be explored. Our rich formulation science and technology library is continually being refreshed with new technologies and chassis and supports NUVISAN’s efficient and effective innovative approach in Topical Product Development.
Our service portfolio includes In Vitro Permeation Testing (IVPT), on human skin obtained from elective surgery, to evaluate drug delivery into the various layers of skin and receptor fluid. Thus, IVPT can be used to support selection of API candidates in preliminary studies and formulation and dose for subsequent pre-clinical and clinical testing. IVPT can also be used to aid in clinical study design or as support for troubleshooting.
Formulation Selection
NUVISAN’s contemporary screening tools accelerate development efficiency and effectiveness. Physical stability of up to 12 prototypes can be assessed in a matter of hours, using our LUMiSizer platform. The optical system of the LUMiSizer enables analysis of particle and droplet velocity distributions for creaming and sedimentation phenomena without the need of any material data while performing particle sizing (ISO 13318- 2). This technique provides tremendous time savings compared with conventional approaches which can take weeks and months.
The RapidOxy device artificially accelerates the oxidation process using increased temperature and oxygen pressure. It is a rapid test method to determine oxidative stability using ~5g of sample without preliminary sample preparation. Raw materials and finished products can be easily and rapidly evaluated to optimize antioxidant combinations at an early stage in formulation development. This technique is another powerful tool that substantially reduces development duration and provides data in a matter of hours comparted with weeks and months that are typically required with conventional methodologies.
Screening of microbiological preservation systems can be accelerated using our BioLumix system. Results can be obtained in 48 hours as compared to 14-28 days with conventional techniques. Consequently, NUVISAN scientists can identify and develop customized and optimized antimicrobial preservative systems for your project much more rapidly.
NUVISAN’s complementary, high-tech and express approach involves close collaboration between formulators, chemists and analysts, shortens development and ensures your projects reach proof-of-concept studies faster.
Quality By Design
Quality by Design (ICHQ8) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. NUVISAN’s experts have applied this approach to topical product development and can offer their expertise to facilitate dossier submission and registration.
Support Of Regulatory Dossier
Historically, there have been fewer generic products for dermatologic drug products compared with other disciplines. Recently, the FDA has encouraged a microstructure (Q3) approach to demonstrate equivalence of generic drug products to innovator drug products using robust science and regulatory pathways. The combination of Q1 (qualitative sameness) and Q2 (quantitative sameness) and Q3 (same physical and structure qualities that define a product) equivalence pathways is designed to reduce the barriers to topical generics that were associated with difficult-to-conduct clinical bioequivalence endpoint studies.
NUVISAN experts have in-depth knowledge and experience with key techniques that enable detailed and comprehensive microstructure characterization and performance that can help you understand your drug product and meet regulatory expectations. We have extensively exploited pertinent techniques to provide insights into complex topical products.
Troubleshooting And Process Development Support
Our scientific group has a proven heritage of effective product and process development with team members being responsible for the creation of formulas and corresponding processes that supported several commercially successful products. NUVISAN with its knowledge of formulation development is your partner of choice for troubleshooting and process development support.
Intellectual Property
Our scientific group has a deep IP culture and will help you to develop innovative patentable formulations or support your IP related experiments requests.
Life cycle management is part of our DNA, and we would be pleased not only to listen to your needs and discuss possible options but also create and develop in our labs your next generation product.
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