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In vitro Release Rate Test (IVRT) Method Development & Validation
As you develop a topical or novel dosage form, IVRT using Franz diffusion cells can be used to help you select a formulation and progress to in vivo studies.
| Analytical Solutions can develop and validate in vitro performance tests and accompanying HPLC methods for products utilizing the following routes of administration: |
- Topical
- Sublingual
- Buccal
- Ophthalmic
- Vaginal
- Rectal
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We also provide analytical support for post-approval changes where SUPAC-SS guidelines require in vitro release rate testing (IVRT).
| Analytical Services |
- Analytical method development, validation and testing
- HPLC (High Performance Liquid Chromatography)
- Dissolution
- UV-Vis Spectroscopy
- FTIR (Fourier-transform Infrared Spectroscopy)
- TLC (Thin-layer Chromatography)
- Karl Fisher water content determination
- In-process analytical testing (manufacturing support)
- Cleaning Validation Sample analysis
- Process Validation Sample analysis
- Batch/lot release testing for Active Pharmaceutical Ingredients (APIs) and formulated drug products
- Preclinical dosage confirmation
- Stability testing (to support formulation development, preclinical, clinical and aNDA activities)
- USP testing
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Dosage Forms Supported
Since its inception, the core expertise of Analytical Solutions has been the development of in vitro release rate tests (IVRT) and the associated analytical methods for topical and alternative dosage form products. These include:
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Topical Dosage Forms |
- Creams
- Ointments
- Gels
- Oils
- Laquers
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Oral Dosage Forms |
- Tablets
- Capsules
- Fast dissolving tablets
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Alternative Dosage Forms |
- Ophthalmic suspensions
- Suppositories
- Buccal patches
- Polymer gels
- Films
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We enjoy thinking creatively and working collaboratively with clients to meet the business need effectively and efficiently. |
