Pilot/R&D to Phase II Clinical Trial Batches (including placebos) under Form 29 License or Form CT-11 Permission. Across the board: from conventional oral and topical formulations to transdermal systems, pulmonary drug delivery, liposomes, nanoparticles.

The facility offers

• Design, development and manufacture of new formulations.

• Optimize, validate and scale-up Processes.

• Develop and validate In-Process Quality Check (IPQC) protocols.

Development of standard testing procedure, batch release specification and in-process quality control SOP. All pharmacopoeial tests, excipient compatibility, stability, photostability, CQA, CPP, STP, BRS, MSDS development.

The facility offers

• High-end spectroscopy (IR, NMR, mass)
• Microscopy (scanning/ transmission, atomic force, confocal, fluorescence, optical),
• Chromatography (LC-MS/MS, GC-FID/MS, HPLC)
• Differential Scanning Calorimetry
• Per-monograph testing for batch release
• Development of Standard Analytical Protocol (SAP/STP) for NCEs
• Raw Material Testing (see case study)
• IPQC protocol development and validation
• Solid state characterization.
• Metal analysis by AAS (Atomic absorption spectrometry).
• Development of Product Monograph
• Excipient compatibility, stability, photostability, CQA, CPP, STP, BRS, MSDS development

IND enabling studies; in-vitro and pre-clinical PK in rodent and non-rodent species. compartment/non-compartment PK modeling and simulation. Preclinical bioavailability and bioequivalence studies.

The facility offers

• In vitro pharmacokinetics:- Stability studies (SGF, SIF, plasma, microsome, S9), protien binding, CYP profiling, metabolism studies.
• Clinical and preclinical pharmacokinetics, metabolism and biodistribution in mice, rats, hamsters, rabbits.
• Toxicokinetics
• Bioanalytical method development and validation as per regulatory guidelines.
• Pharmacokinetic Modeling and simulations

Case Study: Pharmacokinetic Modeling and Simulations:

Mean serum concentration versus time profiles of isoniazid in monkeys administered a single i.v. injection (top), a single inhalation of MP containing 0.25, 2.5 and 25 mg of each drug, (middle) and at presumed steady state (bottom). Scatter points corresponding to line colour represent group means (n=4) and error bars show standard deviation (SD). Values from individual animals are also plotted as additional scatter points.

Simulation of pharmacokinetics/ toxicokinetics following daily dosing with CDRI Compound S011-1793, computed from observations at 45 mg/kg.