DRUG DEVELOPMENT
DRUG DEVELOPME
DRUG DEVELOPMENT
We have the capabilities across all stages of cannabis-based drug development
A trusted partner
The quality of cannabis-based active pharmaceutical ingredients (APIs) depends on specific chemical and physical characteristics that impact the medical product’s stability and efficacy. In order to successfully develop a medical product, it’s very important to understand the chemical and physical nature of the active ingredient and optimize accordingly.
We examine the following parameters:
- Content or activity
- Chemical degradation products, light sensitivity
- Compatibility of active ingredients and excipients
- Solubility
- Stability
Additionally, we offer the following services for seeking and applying certain qualities of an active pharmaceutical ingredient:
- Active pharmaceutical ingredients sourcing in accordance with current regulatory requirements
- Active pharmaceutical ingredients obtaining (with partners)
- Active pharmaceutical ingredients-IP search
Sinceritas provides medical product development as a complete package or in individual modules. We have the expertise to develop solid, semi-solid, and liquid dosage forms with chemically defined and biological active ingredients. We cover oral, topical, inhalational, and parenteral medical products.
We offer the following product development services:
- New development of medical products and related products
- Development of innovative products for poorly soluble active ingredients or new applications
- Product optimisations
- Generic developments
- Development of herbal medical products
- Development analysis
- Manufacture, packaging, release, and distribution of clinical test samples
A thorough analysis is crucial for the success of individual steps in formulation development.
We operate with the following analytical technology:
- High-performance liquid chromatography with a diode array detector
- High-performance liquid chromatography with a fluorescent detector
- Gas chromatography with a flame ionization detector
- Single quadrupole gas chromatograph-mass spectrometer
- Triple Quadrupole Gas Chromatograph Mass Spectrometer
- High-Performance Liquid Chromatograph Triple Quadrupole Mass Spectrometer
- Inductively Coupled Plasma Mass Spectrometer
We offer the following development analysis services:
- Test-method development/validation
- Stress tests, stability testing
Sinceritas has the expertise to develop medicinal products in accordance with the current requirements of the ICH-Q8 to ICH-Q10 guidelines. We apply a Quality by Design (QbD) approach and the principles of static Design of Experiment (DoE) to our medicinal-product development to assure a high level of manufacturing quality performance and a safe, effective drug supply to the consumer.
We offer the following services:
Preparation of proposals, which may include:
- Milestone-based activities
- Performance of risk analysis
- Creation and selection of suitable DoE models, also as part of a QbD
- Model implementation of feasibility studies
- Statistical evaluations of formulation results
- Scale-up of prototype formulations, also from DoE studies
- Stability testing of prototype formulations, also from DoE studies
- Definition of the design space
- Scale-up of confirmation batches
- Production of validation and stability batches