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Preformulation Studies
Drug development projects begin with preformulation studies. Our capabilities include:
- Excipient compatibility studies
- pH stability profile
- Intrinsic dissolution studies
- Partition coefficient studies
- Solubility profile
- Particle size and density determinations
- Thermal analysis
Formulation Studies
We specialise in the development of a complete range of dosage forms including:
- Solid dosage forms – tablets, capsules, granules and powders
- Liquids – includes suspensions and emulsions for oral and topical use
- Sustained release dosage forms
- Development of aqueous and organic film coating
- Suppository formulations
- Parenteral products
For:
- Pharmaceutical
eg. Drug treatments, Psoriasis, Acne, Pain Relief, Skin Blemishes, etc.
- Cosmeceutical and Personal Care
eg. Complete Skin Care, Sunscreens, Aromatherapy, Skin Tanning, Skin Whitening, etc.
- Veterinary
eg. Drenches, Pastes, Tablets, Injectables, etc.
Stability Studies
- Development and validation of analytical methods to appropriate guidelines
- Supply and execution of method transfer protocols
- Expert regulatory documentation for regulatory submissions world-wide
- Stability testing according to TGA, ICH or other appropriate guidelines
Revamping Existing Products
Many products undergo updates during their product life cycle. These changes may be to reduce manufacturing costs or change a product’s image or functionality. These changes will help preserve market share and extend the life cycle of many products. We can work with you in this regard to maximise your investment.
Small Scale manufacture
Often small scale manufacturing is required for cosmetic products for test markets or niche products. Batches from our formulation range or yours in quantities of 20Kg to 500Kg, in bottles, jars or tubes, can be manufactured. We also offer a complete range of Own Brand products, and can present complete finished product to your door.
For larger scale manufacturing, please see NxGen Cosmetics.
Substantiation of Product Claims
Through our associates we can offer a suite of dermatological tests such as SPF Evaluation (plus UVA testing and water resistance), Repeat Insult Patch Tests, Cumulative Irritancy tests, Skin Lightening and Skin Aging tests.
Clinical Trial Supply
A pharmacy registered with the Pharmacy Board of NSW is on site which specializes in the compounding of custom made pharmaceuticals. We have facilities for the preparation of all solid and liquid dosage forms for clinical trials. This included a full packaging and monitoring service for clinical trials. We can work with your CRO or provide a full package..
Regulatory Affairs
We can arrange listing or registration with all government bodies including TGA and APVMA.
Expert Assistance
We can assist with publications, patents and expert advice for legal issues.
Compilation of Documents
When developing new products, many registration documents need to be compiled. NxGen’s experience when dealing with these documents, especially TGA requirements will save your company precious time, money and resources. This will assure that you have the best of quality product and meet the appropriate standards for Australia and New Zealand use. International equivalents can also be organised.
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