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Semler Research Formulation Development

Posted at: Offers to Sell and Export | Posted on: Mon 22 Mar, 2010 12:21 pm |
 
semler research formulation
Products Photos CatalogSemler Research Photos Catalog



Preclinical Formulation Development

- Analytical Development: Assay and relative substance method


development based on already existing drug substance methods with partial validation to perform the preformulation studies.

- Physico chemical evaluation, solubility studies: pH dependent aqueous solubility, solubility studies in alcohols and polyols solvents, solubility in co-solvents and surfactant assisted solubility

- Inherent dissolution study in various pH conditions

- Salt design/screening and selection

- Dissociation constant redetermination

- Partition coefficient and log P determination

- Polymorphism study

- Particle size, surface area, bulk/tapped density determination

- Stability study: Solution stability, pH depended solubility, process equipment compatibility study, filter compatibility study, solid state stability, stress stability, photo stability, accelerated stability study as per ICH guidelines

- Dynamic moisture absorption study

- Drug excipients interaction study in solution form

- Preclinical formulation

- Stability study of preclinical formulation

- Closure container compatibility study.

Phase I Formulation Development Services

Based on available information on physico-chemical properties, dose, early animal Pk study final "plug and play" formulation development service will be provided

- Analytical Development: Assay and relative substance and dissolution method development based on already existing drug substance methods with partial validation to perform the preformulation studies

- Drug excipient interaction study: 10-20 common excipients (GRAS and pharmacopeial materials) quantities as per the limit in IIG for similar kind of formulation or as required designing a particular dosage form.

- Optimizing capsule or tablet of a typical size for oral dosage forms.

- Setting product specifications with respect to dissolution

- Bench scale formulation manufacturing (50 gm Batch, batch size might vary based on the availability of the drug substance)-identifying critical process parameters.

- Setting up specification for API

- Manufacturing of feasibility batches (200.0g to 500.0 g)

- Identifying final formulations-based on the required specification

- Clinical material manufacturing and packing as per GMP.

- Informal stability study in HDPE bottle and various blister packing

Phase II-III formulation Development Services

Based on available information from the phase I formulation development study

- Complete analytical validation as per ICH guidelines

- Development of discriminating dissolution media

- Formulation development with three batches of API, finalizing the trade dress of the formulation.

- Final preformulation: drug excipients interaction, process equipment interaction studies.

- Scale-up manufacturing and process optimization and validation, and manufacturing exhibit batch.

- Setting up final product specification for QC

- Supporting CMC of new drug application

Formulation Development Services for ANDA

- Complete analytical development and validation as per ICH requirement.

- RLD evaluation

- Drug excipient interaction study

- Formulation development to match the dissolution property of RLD in OGD and multimedia dissolution.

- Accelerated stability in primary pack along with RLD

- Scale up-identifying the critical process parameters and process optimization.

- Technology transfer

- Bio-batch or exhibit batch manufacturing

Equipment

- Multi Station Tablet Press(D & B Tooling with instrumentation)

- V blender

- Planetary Mixture

- High Speed Mixture and Granulator

- Dry Granulator

- Pan Coater

- USP dissolution Apparatus with auto sampler

- Tablet: USP Hardness Tester, USP Disintegrator and USP Friability Tester

- Stability Chambers (Complies with ICH Guidelines)

- HPLC(Waters Alliance 2695) with PDA Detector

- Differential Scanning Calorimetry (Shimadzu)

- FTIR(Shimadzu)

- Thermo Gravimetric Analyzer (TGA)(Shimadzu)

- UV-Vis Spectrophotometer

- Moisture Analyzer

- Diffusion Cells, For Permeation Studies

- Cell Culture Facilty for Permeation Studies using Caco2 and MDCK Cell Lines



Company Contact:

semler photo
Contact Name: Mr. Subbaiah Md
Company Name: Semler Research Centre
Email: Email
Tel: 91-80-26640681
Fax: 91-80-26640683
Street Address: #75A, 15th Cross,
1st Phase, J.P.Nagar, Bangalore 560078
India
Website: http://www.semlerresearch.com
Member name: semler
Country: India-IN India
Member Since: 22 March 2010
Total Leads: 10 semler Import Export Business Leads
Business focus: Contract Research, Clinical Research, Formulation and Pre-Formulation Services
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