July 1 2022
Preclinapps has started developing Letrozole implant for sustained release for research...



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Example of study design of novel compound feasibility testing

Study design
Targeted dose (µg/d) and release duration (months) for the compound(s) is set by Customer in discussion with PreclinApps.
If water solubility for API does not enable in vitro dissolution studies in pure water/PBS based
systems, the solubility may need to be increased with agents such as HP-β-cyclodextrin (BCD) or Tween20/80.
Active ingredients will be obtained from the Customer or PreclinApps will order them on Customers behalf. All other materials will be ordered by PreclinApps Ltd.

Project includes commonly following phases and studies:
Study 1: Feasibility phase for materials and API, project feasibility steps 1-6 (Appendix 1)
- Compatibility evaluation and crosslinking test of API and polymer materials based on physico-chemical properties, curing trials. Decision from Customer of wanted daily release rate (µg/d)

Study 2: Set up of analytics for API, manufacturing of test implants and preliminary dissolution study
- Setting up of HPLC-analytics for API
- Totally 8-10 implants (4 designs, 2 parallels), timepoints: 4h 1d, 4d, 7d, and 14d
- Report on evaluation of applicability of silicone-based dosing system according to Customer´s specifications

Study 3: Extensive dissolution study for API from prepared implants
- Recommended for more refined and longer study of daily release
- Preparation of new optimized implants
- Dissolution study of 12 implants (3 designs, 4 parallels), timepoints: 4h, 1d, 4d, 7d, 14d, 21d, 28d, 35d, 42d, 49d, 56d, 63d, 70d, 77d, 84d and 91d.

Customer can decide of the continuation after each study.

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