CN

innovation and internationalization

Qingdao Baiyang Pharmaceutical has multiple experience in the development of oral solid dosage forms, tablets, capsules, suspensions, granules, etc., especially in the development of sustained-release and controlled release products. Its self-developed products include osmotic pump products, including single chamber and double chamber osmotic pumps, enteric coated delayed release drug delivery products, sustained-release pill coating products, as well as conventional process products such as wet granulation, direct compression, dry granulation process products, etc.

drug development

Technology leads innovation and research and development

(1)Permeation pump technology

The osmotic pump coating technology relies on osmotic pressure regulators to produce a constant osmotic pressure effect, releasing drugs at a constant rate of 24 hours. This is the advantage that distinguishes it from ordinary tablets or skeleton sustained-release tablets. The advantages of osmotic pump drugs in clinical practice are that the blood drug concentration in the body is more stable, the therapeutic effect is more long-lasting, the blood drug peak phenomenon is avoided, and safety is improved. In addition, patients have a higher compliance with medication, taking it once a day, reducing the risk of missed or multiple doses.

 

Qingdao Baiyang Pharmaceutical has mature osmotic pump coating technology, which is divided into single chamber and double chamber osmotic pumps. Our company has independently developed multiple products and successfully launched them for production and commercial sales. For example, the single chamber osmotic pump technology products include metformin hydrochloride sustained-release tablets (III) and carbamazepine sustained-release tablets (II) (commissioned production), and the double chamber osmotic pump technology products include nifedipine controlled-release tablets and glipizide controlled-release tablets (commissioned production). The product development adopts the concept of "quality comes from design", and conducts systematic and scientific evaluation and research on key material properties such as CMA (permeability pump functional polymer, etc.) and key process parameters CPP, using DOE design to ensure stable quality, controllable quality, reproducible process, and continuous quality improvement throughout the product lifecycle.

 

(2)Micro pill sustained-release coating technology

The sustained-release coating technology of microspheres can achieve controlled drug release, intestinal localization or targeted administration, pulse administration, timed or programmed administration, mask taste and improve taste, and significantly reduce the toxic side effects of drugs. This technology can be made into capsules, tablets, and dry suspensions. For example, the sustained-release capsules of Meverine Hydrochloride can be controlled and administered once a day, and can be effective for 24 hours; Duloxetine hydrochloride enteric coated capsules can be delivered through intestinal targeted administration, avoiding gastric irritation and degradation by gastric acid, improving drug stability, and ensuring drug safety.

Technical Feature 1: Permeation Pump Controlled Release Formulation

Structural diagram of osmotic pump controlled release dosage form

Comparison of blood drug concentrations by different preparation technologies

  • 近乎零级速率释放,单位时间内药物释放量恒定
  • 不受胃肠道PH影响,血药浓度平稳,不良反应小
  • 24小时保持血药浓度,一天一次给药,提高患者依从性

Mechanism of action of osmotic pump controlled release dosage forms

Technical feature 2: Micro pill coated dosage form