Process
and technology development for extraction of herbal drugs : We provide complete solution for technological development from lab level to industry scale for herbal drug extraction. We judiciously work out the parameters which include selection of solvent, time for the process and temperature at which extraction is to be carried out. The process so developed will ensure extract with high content of bio-molecule at the same time helping in saving time, energy and cost.
Development of new formulation, application, process and technology :
Development of herbal formulations is a specialized field which needs in depth knowledge of herbal raw materials, its dose, their chemical compositions, possible interaction between chemicals from other herbs, compatibility of excipients, packing material, and final application of the product. We undertake to develop the herbal drug formulation on scientific basis taking into considerations the various aspects associated with it.
Our formulation development capabilities include :
- Feasibility study
- Formulation composition
- Designing of dosage form
- Process optimization
- Scale up
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Development of Analytical profile :
Phytochemical methods have been modernized considerably over the past decades. Classical chemical methods have been progressively replaced by high performance instrumental techniques. In many cases however botanicals and herbal medicinal products resist analytical characterization due to the complex composition of plant extracts and difficulties in finding analytical targets and markers the contributes to the pharmacological and therapeutic effects.
We at THS with the help of modern phytoanalytical chromatographic methods develop complete analytical profile (Chemical fingerprinting) of herbals.
Stability Profile :
Stability testing is necessary to ensure the product is of acceptable quality throughout its entire storage period. In order to do this, it is necessary to monitor compliance of the product with a suitable quality specification throughout the shelf life. It is not acceptable to only test at the time of expiry, for example, on a retention sample (even though the results of this type of testing may provide useful information about the overall stability of the product).
Stability testing is useful for :
- Guiding formulation development
- Selecting packaging materials
- Defining expiration dating
- Selecting labeling text
- Monitoring the quality of marketed formulations using a sampling of
batches made during production manufacturing
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We at THS
carry out the stability studies as per the ICH guidelines and provides the following services to support stability testing :
- Study design, in cooperation with the client
- Protocol development for client approval
- Storage of stability samples (alternatively, storage may be performed
by the client and ASI may receive samples for testing)
- Testing of stability samples
- Interim stability reports, provided after each testing interval
- A final stability report after the last testing interval
- QA review of reports and data.
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Clinical Data : The common belief that "if a polyherbal product has been prepared as per the traditional system of medicine it is bound to be safe and effective" is not true. If you would like a herbal product to have an edge over the competition then it needs to have a health benefit claim. Well designed Double Blind Randomized Clinical trials can prove such health claims. India has now become the favorite destination to conduct Clinical Research due to modern facilities, high patient population and advanced data management skills
We at THS
has a protocol designed to meet the specific requirements of the clients in the field of clinical registration of new pharmaceutical products from phase I to phase IV, including Bioequivalence, Bioavailability, Pharmacokinetic/Pharmacodynamic studies, Statistical Analysis and Data Management strictly adhering to ICH and GCP guidelines. The company offers competitive and high quality clinical trial
services to domestic and international pharmaceutical and Bio-Pharmaceutical companies.
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