Formulation Studies

Overview

PolyCrystalLine formulation studies involve developing a preparation of the drug that is both stable and acceptable to the patient.
It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and studies have to be carried out to ensure that the drug is compatible with these other substances.

Formulation study stages

Pre-formulation stage

This involves the characterization of a drug’s physical, chemical, and mechanical properties in order to choose which other ingredients should be used in the preparation.

Formulation stage

During the formulation study itself, it is necessary to consider such factors as particle size, polymorphism, pH, and solubility, all of which can influence bioavailability and hence the efficacy of a drug.

The drug must be combined with inactive additives, using a methodology that ensures that the quantity of drug present is consistent in each dosage unit (e.g. a single tablet).

Tailor-made formulation studies

PolyCrystalLine can also construct formulation study stages that are tailored to specific drugs, to identify excipients and their solid-state behaviour.

Quality & Certification

PolyCrystalLine s.r.l. has been inspected and approved by the Italian Health Department for compliance with Good Laboratory Practice (cGLP).

This certification includes:

• XRPD analysis (quantitative/qualitative)
• Particle size distribution analysis
• DSC Analysis
• TG Analysis
• FT-IR (quantitative/qualitative)
• Karl Fischer
• Melting Point
• Dissolution Test
• U(H)PLC
• FT-Raman
• DVS Intrinsic
• PSD
• EASYwater

PolyCrystalLine is also completing Good Manufacturing Practice (cGMP) certification in application, to allow development and validation of XRPD quantification methods for batch release.

Resources

Click on PolyCrystalLine Formulation Studies for more information.
Click on PolyCrystalLine to contact the company directly.

Supplier Information
Supplier: PolyCrystalLine S.R.L.
Address: VIA F.S Fabri, 127/1 40059 – Medicina (Bologna), Italy
Tel: +39 051 6970791
Fax: +39 051 851 847
Website: www.polycrystalline.it