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DRUG DEVELOPMENT

DRUG DEVELOPME

DRUG DEVELOPMENT

We have the capabilities across all stages of cannabis-based drug development

A trusted partner

Sinceritas has the knowledge, facilities, and equipment to assist you through all stages of cannabis-based drug product development. Our team is experienced and qualified to face any innovative challenge in the pharmaceutical field and respond with timely solutions.

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

Laboratory designed, equipped, and organized according to GMP and ISO 17025 requirements

Class D Clean Rooms
Physico-chemical Laboratory
Microbiological Laboratory