1. Formulation and Process Development_Drug Product Development_CMC Study_Service_Bostal Drug Delivery Co., Ltd. EN
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Formulation and Process Development_Drug Product Development_CMC Study_Service_Bostal Drug Delivery Co., Ltd.

Service

Service

CMC Study Manufacture Preclinical Study Clinical Study Drugs Registration

Prescription Process Development

 


Based on the customer’s requirements and physicochemical properties of the API and excipients, the most suitable dosage form will be selected and the formulation and process will be established as well as corresponding process control parameters.


     Formulation and Process Development Capability:

◆Selection and analysis of reference products

◆Screening of API, excipients and packaging materials

◆ Reverse engineering study for generic products

◆QbD-based optimization of formulation and process parameters

Compatibility and stability study

Process scale-up and technology transfer

 


The Development Capability of Innovative Drug Products:

Sterile Formulation Technology

Non-sterile Formulation Technology

Featured Formulation Technology

Injectable microspheres technology

Solid dispersion technology

Oral film technology

Long-acting implant technology

Oral nanocrystal Technology

Transdermal technology

Injectable nanocrystalline/nanoparticle technology

Gastral-retention technology

Dry suspension technology

Injectable gel technology

Osmotic pump technology

Oral disintegration tablet technology

injectable liposome technology

Matrix sustained release technology

Enteric-coating technology

Injectable emulsion/nano-emulsion technology

Pellet release technology

Soft-gel technology




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