Frequent dosing may be required when a drug has a short half-life and is eliminated too quickly to provide a therapeutic effect. However, this can result in safety and efficacy issues as it may results in undesirable spikes in plasma levels and compromised bioavailability. Furthermore, if patients need to take numerous doses daily, this may also result in compliance issues.

In order to overcome this problem, drug delivery technologies can be utilized to sustain a drug's release at a specific rate over a defined period of time while maintaining the required drug plasma concentration range. This type of drug release profile can prevent drug toxicity and reduce dosing frequency.

Benefits of a sustained release profile include:

• Constant drug delivery within the required therapeutic range leading to:
  - enhanced safety profiles
  - enhanced efficacy profiles

• Less-frequent doses leading to:
  - minimization of peaks
  - improved patient compliance

Matris® technology controls the amount and timing of the release of drug compounds in the human body. Matris® technology is based on the use of a blend of hydrophilic and hydrophobic polymers that control drug release through swelling, gelling and erosion of a matrix tablet. This technology enables successful formulation with both soluble and insoluble drugs.
 

• Flexibility: Drug release can be adjusted to your dissolution requirement, from 6 hours to 24 hours with soluble or insoluble drugs. Matris® technology is very effective in the development of once-a-day tablets.
• Regulatory compliance: all ingredients used are EP/USP approved.
• For generic projects, Matris® technology is effective to obtain similar dissolution profiles compared to the reference products.
• Easy to manufacture : Because the technology relies on dry blends and direct compression, the production of Matris® tablets does not require specialized manufacturing equipment or facilities.
• Cost effective due to an easy manufacturing process.
• Patent protection: Matris® formulations offer patent coverage providing extension of market exclusivity.

 

Physica Pharma has a step-by-step approach as described below:

Feasibility study

The objective is to develop formulation prototypes having the best possible dissolution profile.
For generic products, the objective is to have similar dissolution profiles compared to the reference products. A statistical comparative study is performed in order to verify if the matrix tablet dissolution profile is similar to reference product. The similarity of dissolution profiles is evaluated from the calculation of the similarity factor f2.

Development phase

If the client is satisfied with the prototypes produced during the feasibility study, the company enters into a development step. Physica Pharma proposes a development plan including formulation process optimisation, analytical development and validation, production of pilot batches and stability study with the aim to prepare a CTD dossier for the submission of a Marketing Authorization Application.