We offer integrated oral solid dose services right from pre-formulation services to commercial manufacturing. Our expertise in chemistry helps our customer accelerate their NDA program by quick salt screening and supply of non-GMP Drug Substances (DS) and Drug Products (DP) for preclinical studies.
Cross-functional teams such as PK-PD, API synthesis, salt screening, toxicology, process engineering and analytical development teams are co-located and work in an integrated manner for efficient development. Continuous feedback among the teams at each stage of the life cycle helps resolve the issues during the early stage of NCE development and parallel activities help expedite the timelines for product delivery.
We also offer “Fit for purpose formulation” development for pre-clinical and FIH studies based on molecule pharmacokinetic behavior, excipient compatibility studies and screening of excipients.
Phase I to Phase III cGMP Clinical Supply/technology transfer/registration and Commercial Manufacturing:
Oral Solid Dose Pre-formulation Services Include:
- API Physico-chemical Characterization: Powder flow characteristics, particle size distribution and hygroscopicity, etc.
- Molecule Solubility Behavior: pH solubility profile, solubility in organic solvents and solubility in Fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF) and Simulated Gastric Fluid (SGF) media and intrinsic solubility
- Molecule Stability Behavior: Solution, solid-state, forced degradation studies (acid/base, neutral hydrolysis, thermal degradation, oxidation and ICH photostability, etc.
- Molecule Inherent Properties: pKa, Log p/Log D
- Solubility Enhancement: Particle size reduction, micro-environmental pH modification, complexation, inclusion of surfactants, solid dispersion, and lipid drug delivery system
Aurigene Pharmaceutical Services is
a leading CDMO/CRO
that provides contract research and manufacturing services
Solid Oral Formulation Development and Manufacturing Services:
We offer development and manufacturing services of conventional dosage forms such as immediate-release tablets, chewable tablets, orally disintegrating tablets, granules for suspension and capsules.
In addition to traditional forms, we have the capability for developing and manufacturing of highly complex formulations involving
- Bi-layer tablets
- Multi particulate system (pellets & mini-tablets)
- Delayed and modified release
- Floating drug delivery system
- Very low and high dose products
- Taste masked formulations
Niche Technologies Include:
Phase appropriate oral solid dosage services include
We offer innovative phase-appropriate dosage form design that can help customers achieve flexible dosing during early clinical phases that do not require a major change in the composition and process when venturing into the advanced clinical phase of development and commercial stage.
Formulations include:
- Pellets
- Granules
- Multi-unit tablet encapsulated in hard capsule or filled into sachets.
These dosage forms can be offered to age-appropriate populations (pediatric and geriatric age groups) combined with taste-masking technology.
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Other Services
- Dissolution Studies and Testing
- Drug Excipient Compatibility Studies
- Drug Product Characterization Studies and Testing
- Early Phase Formulation Development Services
- Formulation Studies
- Pharmaceuticals Stability studies
- Preformulation Studies
- Topical Formulation Product Development and Manufacturing Services
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