Formulation Development Studies

EZ Labs performs the following studies in support of all stages of formulation development process:

Excipient Compatibility

Study of drug-excipient compatibility is an important phase in the pre-formulation stage of drug development. The potential interactions between      drugs and excipients have effects on the chemical, physical, bioavailability and stability of the dosage form. EZ Labs provides drug-excipient compatibility studies to provide data for drug-excipient interaction which can further help in selection of excipient for the development of stable dosage form.

Solubility Screening

Our Scientists perform solubility (including equilibrium pH solubility profiles) of lead discovery and development candidates and other IND-enabling studies.

Drug solubility is a fundamental property that has to be evaluated in the early stages of drug discovery. Various parameters will have an effect, such as the polarity of both the drug and the solvent, drug particle size, in addition to the parameters associated with the solution process, such as the temperature and agitation.

Early Development Stability

Early in development, pharmaceutical research organizations develop products with a primary focus on patient safety. Data are generated at appropriate storage conditions to demonstrate or support the stability of the drug substance and product to assure product quality through the clinical study period. 

Photostability Studies

The intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change. For confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter (refer to ICH Q1B guidelines). 

Thermal Cycling and Freeze-Thaw Studies

Temperature sensitive medicinal products should be transported in a manner which ensures product quality is not adversely affected. Transportation of product typically takes place within a commercial environment. Factors such as traffic events and unforeseen weather conditions can delay shipments and have a deleterious effect on the product. The range encountered during transportation may differ from that which is specified for long term storage, ascertained from stability studies. To understand the effect these excursions may have on a product, Thermal Cycling studies are completed. Also known as freeze thaw studies, they are used to evaluate the potential effects of temperature deviations that may occur during the transport process.