Each project is structured to meet the needs of the client company and costed accordingly. However, typically a project might proceed as follows:

SoliScreen - SOLIQS recommends starting with its screening system SoliScreen® to provide information on the basic parameters for development of the Meltrex® and NanoMorph® formulations (for example, solubility and/or thermal stability of the drug compound in various polymer matrices).

Small-scale Formulations screening (evaluation of extrudability and extrudate properties)
Initially, this is usually carried out on bench-scale extruders. Based on the results of this formulation screening and stability testing, we jointly select with our customers formulations for testing in animal models.
After results of the animal study are available we would select a lead formulation and dosage form (tablets, calendered tablets, capsules) for further development.
Our analytical services support the formulation studies through, for example, method development, and checking drug crystallinity, potency, drug release, etc and testing short-term stability.

Phase I – requirements for Clinical Trials (CT) Transfer of a jointly selected lead formulation to pilot scale or larger equipment. Manufacturing trials to define process parameters, cleaning verification, etc. with a further analytical program which could cover drug potency/purity, content uniformity, dissolution testing, drug crystallinity including analytical method validation.
As a next step we could go forward with manufacturing a pre-batch based on manufacturing process and formulation composition.
The pre- batch provides supportive data, which are necessary for finalization of the manufacturing instructions (MI) needed for CT manufacturing. Preparation of batch records and manufacturing of the clinical batch itself is generally performed meeting current GMP standards.

CT samples can be provided to our customers as either bulk material or fully packaged material for the clinical studies, together with the required stability testing, clinical lot validation and release testing by Quality Control.
Our team could also help you in compiling the Investigational Medical Product Dossier (IMPD) and Investigational New Drug (IND) Application.
Following successful results of the Phase I (or Proof of Concept) study we would start with up-scaling the manufacturing process in pilot-plant scale (usual batch size 25-100 kg) or production scale (> 100 kg) including samples for Phase II/III studies.