IIIM pharmaceutical development team is experienced in
formulation development of both small molecules and macromolecules
into a diversity of formulation presentations. Preclinical
formulation development for developing, manufacturing
for preclinical pharmacology and GLP toxicology studies.
Formulation expertise includes development of a wide variety
of dosage forms appropriate for clinical trials and commercialisation.
In support of these activities, we conduct formulation
feasibility studies, scale-up studies and stability studies.
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We undertake formulation development
challenges of biopharmaceuticals and to successfully
overcome them. |
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Explore and learn about unique challenges
in the formulation development of drugs from natural
products. |
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Bioanalytical methods used in the
physiochemical characterization and preformulation
studies. |
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Design and conduct stability studies.
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Chemical modification techniques useful
in the development of biopharmaceutical drug products.
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Innovative Formulation Development
Solutions Novel drug delivery systems like nanoparticles,
nanogels, microemulsions, liposomes, dendrimers
etc. |
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Regulatory issues of formulation development,
drug product characterization, and manufacturing
of biopharmaceuticals. |
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Preformulation studies
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Physico-chemical characterization
of drug substance |
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Solubility and partitioning studies |
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Polymorphism studies |
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Powder X-ray diffraction |
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Particle size analysis |
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Qualitative and quantitative thermal
analysis |
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Excipient compatibility studies |
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Rheological studies |
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Packaging compatibility and extractability
studies novel delivery drug technologies |
| Formulation Services |
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Formula and process optimization through
DOE Tablets, capsules, liquids, suspensions and
semi-solids |
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Modified and controlled release tablets
and capsules |
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Evaluation of packaging presentations
based on formulation requirements |
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Bottle, blister, sachet and tube packaging
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Clinical supply and placebo manufacture
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Review of batch documentation by Quality
Assurance team |
| Analytical Research Support |
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Process development support and release
testing |
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Dissolution studies (ICH guidelines)
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Accelerated Stability studies (ICH
guidelines)
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Validated environmental chambers
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25°C/60%RH, 30°C/65%RH |
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40°C/75%RH, 25°C/40%RH |
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40°C/25%RH, 5°C, photostability |
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| Sr. NO |
Name |
| 1. |
Dr. Shashank Kumar Singh |
| 2. |
Dr. Shashi Bhushan |
Formulation Development and Novel Drug Delivery Systems.
State of art cGMP compliant pilot plant for formulation
and development of natural products in various dosage
forms like tablets, capsules liquid orals commissioning
work is underway.
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