Formulation

We can provide a formulation service from the stage of drug screening, GLP toxicology research, preclinical study to commercialization stage, which can meet the needs of our clients at different stages of drug development. The research which we provide mainly involves solid preparation (such as powders, granules, tablets and capsules), semisolid preparation (such as ointments, creams and gels), liquid preparation（such as solutions, suspensions and emulsion), sterilization and sterile preparations (such as injections, freeze-dried powder injections and ophthalmic preparations).

So far, our group had completed multiple liquid preparation projects, two solid preparation projects and one sterile preparations project. These projects are involved in poorly water-soluble drug and the solubility of API is highly pH dependent.

Drug screening stage (nearly 1 week)

According to the mechanism of the drug, proposed indications, the characteristics of experimental animals in early pharmacology and pre-toxicity, we can develop the appropriate formulation and drug-loading efficiency.

• Develop the solutions and suspensions

• Design the maximum and minimum drug-loading efficiency

• Stability of formulation in 24h

• Sample transportation or the transfer of formulation process

GLP toxicology research stage (nearly 6 weeks)

We can develop the formulation technology for GLP animal experiments and manufacture the samples, which meet the various dose concentrations and the requirement for quantity.

• Screening of special preparation technology (if necessary)

• Development of formulation and process

• Optimization the drug-loading efficiency

• Manufacture the samples or the transfer of formulation and process

• Stability of formulation

Preclinical study stage (nearly 7 months)

According to the physicochemical propertied of API, the proposed indications, the data in early pharmacology and pre-toxicity, we can give reasonable suggestions in formulation and specification.

According to the compatibility results of API and ingredients, we will develop the formulation and process. 

Then, we will confirm the main parameter of the formulation and process according to the optimized design scheme which is built by mathematical model.

A pilot-scale product will be manufactured in non-GMP lab and/or GMP workshop. We suggest the clinical sample should be manufactured in this stage. Thus, the clinical trial can be conducted as soon as possible after the clinical licensing obtained.

• Study the physicochemical propertied of API

• Study the compatibility of API and ingredients

• Develop, optimize, confirm the formulation and process

• Develop and verify the analysis methods 

• Quality research and quality standard built

• Study and manufacture the pilot-scale samples

• Study of stability

• Writing the common technical document for the registration of pharmaceuticals

Clinical products subpackaging

According to the design of clinical protocol and the requirements of NMPA/FDA, we can provide the labels and packing boxes of clinical products and make products subpackaging.

• Design and make the labels and packing boxes

• Clinical products subpackaging

• Labeling and cartooning

Commercial production stage

We can transfer the commercial technology or manufacture the product at the named place according to the meets of our clients.

Special service

We can complete super small amount of drug filling into capsules or subpackaging, which the minimum quantity can be achieved to 5mg, and nearly no residue in the machine. It is especially suitable for the manufacturing of toxicological batch samples, registration batch samples and clinical batch samples, which has low dose and is high value-added product.