CONTRACT RESEARCH & MANUFACTURING
FORMULATION:
Allice drugs are providing formulation development and contract manufacturing services.
The state-of-the-art formulation facility having research team comprising of senior scientists. Who have experience in developing safe, effective and efficacious complex drug products meeting global regulatory requirements.
The Formulation Development facility comprises of two divisions:
· Formulation Development Laboratory
· Analytical Development Laboratory
Some of the major activities undertaken are:
Pre-formulation Development
Objective is to generate information useful in developing bio available dosage forms. The study includes information on parameters like physiochemical property of the drug (like drug solubility, partition coefficient, dissolution rate, stability, solid state analysis like polymorphs, particle size), establishment of kinetic rate profile, excipients compatibility studies etc.
Formulation Development
Analytical Development
Formulation Development Laboratory is supported by Analytical Development Laboratory, which carries out the following activities as per GLP requirements:
· Pre-formulation studies like solubility, forced degradation, excipients compatibility.
· Analytical method development, validation and transfer.
· Bio-relevant dissolution for formulation selection.
· Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients.
The laboratory is equipped with sophisticated equipment like HPLC, GC, GC-HS, Dissolution apparatus, FTIR etc.