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Research and Development



 

Ever since China Chemical & Pharmaceutical Co., Ltd. (CCPC) was established in 1952, we have placed a great deal of importance on drug research and development (R&D.) The R&D section was first established in 1960. In order to incorporate the R&D teams of CCPC and CCSB, the R&D center was established at Shulin. The Pharmaceutical Research Center was completed in 2011. CCPC has never stopped enhancing our research and development ability. The leadership in our R&D has accumulated more than 30 years of experience in the pharmaceutical industry. There is not only professionalism in generic drug development but also in domestic and international regulations. Over the years, we have developed various types of drug delivery technologies and we have signed the technological transfer and cooperation agreements with major pharmaceutical corporations in Europe, the United States, and Japan. We have adopted numerous new technologies and concepts in drug development, which in turn have formed a solid foundation for the research of many critical drug manufacturing technologies and enriched our knowledge, abilities, and international foundation. Our future expectation is to develop the new drugs through 505(b)(2) approval pathway which is a fast way to enter the new drug market in advanced countries.

 
Our research and development team also participates in government-sponsored industry/academia projects to establish independent, autonomous technological know-how, and technological platforms.

 

A leader in research and development
There are now over 56 specialized and professional researchers in our research and development team. We value every outstanding personnel and devote to give more opportunities for passing down a high-grade legacy in the field of pharmaceutical industry. Over 198 drug products  approved by Food and Drug Administration have met the BA/BE (Bioavailability/Bioequivalence) and clinical trial criteria. Six extended-release products and two orally disintegrating products have won gold, silver and bronze medals of the Manufacturing Technology of Drug Research and Development Science and Technology Award from the FDA. Our application of Solid Dispersion Technology has been recognized with Taipei Biotech Awards (Merit Award). Based on our unique and leading technologies, we have established many distinctive dosage models and controlled-release drug manufacturing platforms that have brought us many pharmaceutical technology research and development awards.

In the future, our well-developed unique technological platform will integrate many distinctive dosage forms and drug controlled-release technologies and expand the new drug market.
 

A unique technological platform
CCPC, one of the large-scale integrated pharmaceutical corporations in Taiwan, has developed and manufactured various pharmaceuticals with a variety of production lines. Hence, we have accumulated many mature technologies, while establishing unique critical technology platforms.

In addition to the technological know-how to manufacture various drug formulations, we also possess several advanced controlled-release technologies as explained below:

 

Solid Dispersion
A poorly soluble drug is dispersed evenly in an inert carrier at the solid state as a means of increasing drug solubility, a faster dissolution rate, and improvements on bioavailability and stability of the drug due to the particle size reduction. This technique may overcome the difficulties of low oral bioavailability. The solid dispersed intermediates can be further processed into conventional tablets or capsules.
e.g. Tacrolimus
 

Osmotic Pump
Using laser perforation and semi-permeable membrane techniques, the active ingredients are continually released through small pores on the tablet surface. Conveniently, the patient needs only to take the drug once or twice a day to maintaining drug concentration for 24 hours.
e.g. Nifecardia® (Nifedipine); Xadosin ® (Doxazosin);ADHOOD® (Methylphenidate);Pardone®( Paliperidone)
 

Repeated-Release
The technique of embedding a layered subunit within the tablet makes it possible to release the active ingredients in several instances, maintaining consistent drug levels for a long period.
e.g. Finska-LP ® (Loratadine / Pseudoephedrine )
 

Matrix
Taking advantage of matrix structures composed of pharmaceutical polymer materials, the active ingredients in question can be dispersed throughout the polymer before being compressed into tablet forms. The slow and controlled release of the active ingredients is made possible through this technique. Conveniently, the patient needs only to take the drug once or twice a day to maintaining drug concentration for 24 hours.
e.g. Naposin® (Naproxen); Trenfylline® (Pentoxifylline); Glicron® (Gliclazide); Glibudon® (Metformin)
 

Delayed-Release
A pharmaceutical polymer that can only be dissolved in the intestinal tract is applied to the surface of a tablet or the spherical pellets. When the patient takes the enteric-coated tablet or pellets, the active ingredients that are unstable in gastric acid, stimulative to the stomach, or have to be released into the intestine are protected from the stomach. Dissolution and absorption of the active ingredients are delayed until they reach the duodenum or small intestine. This delivery system can prevent patient illness.
e.g. Taquidine® (Lansoprazole)
 

Modified-Release
Numerous small spherical excipients are used as carriers using multi-particulate technology, and after the active ingredients are evenly dispersed or dissolved, they are covered on the surface of the spherical carriers. An additional polymeric microporous membrane is applied to the pellets, then filled into capsules or compressed to tablets. After oral administration, the active ingredients are released through the micropores on the membrane by the peristaltic activity of the gastrointestinal tract.
e.g. Zotan® (Tamsulosin); Rafax® (Venlafaxine)
 

Multiple-Layer
A multiple-layer tablet consists of a long-acting, immediate-release layer and a slow-release layer. The active ingredients are evenly dispersed over the matrix. After oral administration by the patient, the active ingredients are released slowly. Another application is using the matrix as a bone structure, the active ingredients are dispersed evenly into the matrix, and compressed into tablets. Other active ingredients are coated on the tablets after dispersed evenly or dissolved. After oral administration, the active ingredients in the outer film is released immediately, and the active ingredients inside is released slowly. This technique allows for the release of adequate levels for a long period. Conveniently, the patient needs only to take medicine once or twice a day.
e.g. Setizin-CP ® (Cetirizine/Pseudoephedrine); Vantydin 12® (Fexofenadine/Pseudoephedrine); Finska LP 24 ® (Loratadine/Pseudoephedrine)
 

Orally Disintegrating
The drug is designed as a tablet, which is disintegrated immediately in the mouth by the selection of the pharmaceutical materials and the design of the manufacturing process. This dosage form is suitable for both immediate-release and extended-release. It is difficult on the development and scale-up production in order to fulfill the requirements of good taste and drug stability. This model of administration is expected to be beneficial to geriatric and pediatric patients, for treatment of patients when compliance may be difficult (e.g., for psychiatric disorders), and patients who do not always have access to water. An orally disintegrating has become a trend for oral administration, as it has the advantages of patient compliance and the convenience of drug administration.
e.g. Arizole® (Aripiprazole); Zotan® (Tamsulosin); Olan® (Olanzapine)

 

For more product information, please see 
CCPC's Research & Development

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