Pre-formulation is the initial stage in the development of solid pharmaceutical forms, such as tablets and granules. It involves characterizing the active ingredients that make up the formulation through tests such as:
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solubility
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intrinsic dissolution
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particle size
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thermal analysis
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polymorphism.
When properly managed, it is a tool that enables rational development of formulations, generating considerable savings for the company.
Pre-formulation studies become especially necessary when the company has different suppliers for its active ingredient. Problems related to polymorphism, for example, can be solved through a good physical-chemical characterization of these samples.
Our
experience
DEINFAR has an exclusive pre-formulation laboratory with adequate material and human resources to carry out these studies. At the end of each project, a report is issued with all the results and conclusions, and technical seminars can also be held to discuss the data and train the company's employees.
Equipment
of Thermal Analysis
TG
TG/DTA is used to evaluate the heat resistance of inorganic, organic, polymeric and other materials in a variety of ways. In addition, they are used to determine the moisture content of foods and drugs, define drying parameters, evaluate thermal stability and measure metal oxidation reactions. Reaction kinetic analyses are also frequently performed using TG curves.
DSC
The DSC is particularly suitable for measurements of specific heat capacity, melting, crystallization and analysis of the purity of pharmaceutical inputs and products in low sample quantities. It is possible to couple it with an image capture system for observation of samples and verification of thermal events, with the purpose of obtaining the characterization of the substance, the investigation of polymorphs and the compatibility of drug/packaging.
Equipment of
Physical Characterization
Cilas (PSA)
The CILAS 1090 particle size analyzer performs particle size analysis by laser diffraction using the dry and water-dispersed methods.
NOVA 2200e
The BET technique allows calculating the surface area and pore size of pharmaceutical solids (APIs).
Ultrapycnometer
The Ultrapyc gas pycnometer measures the density of solids and semi-solids, which is used to track purity or porosity.
Equipment
of Solubility
Shake Flask
The Shake Incubator is essential for performing drug solubility tests using the Shake Flask method. This test is crucial for assessing pharmaceutical equivalence and analyzing comparative dissolution profiles.
Sirius T3
T3 is a solubility analyzer using the potentiometric method, generating faster analyses with low drug and reagent consumption.
