In the field of pharmaceutical preparations, create a new blue ocean

The first is highly technical. With the development of high and new technology, modern pharmaceutical technology from manufacturing process to pharmaceutical ingredients requires the support of advanced technology, precision equipment and instruments, cutting-edge technical talents and sufficient research and development funds. Pharmacy has become a representative discipline with the cross-penetration of various disciplines and the integration of cutting-edge technologies. For example, biopharmaceutics, physical pharmacy, industrial pharmacy and other sub-disciplines continue to emerge, the research level from the organ level, tissue level to the molecular cell and other micro level, the dosage form from the traditional tablet, capsule, ointment development to new targeted preparations, intelligent slow release preparations, nano drug delivery system. Innovative technology is not only the main driving force to promote the rapid development of the industry, but also an important means for pharmaceutical enterprises to enhance their core competitiveness.

Second, the internal differentiation of the pharmaceutical preparation industry has intensified. In the past two years, under the baptism of new policies such as medical insurance cost control, volume procurement and generic drug consistency evaluation, the overall profit growth of China's chemical pharmaceutical industry has slowed down, the operating pressure of some low-end generic drug manufacturers has increased, and the market demand for high-end generic drugs has gradually expanded, and it is expected that the internal differentiation of the chemical pharmaceutical industry will continue in the future, and the internal structural transformation and upgrading and adjustment of the industry are the main.

Third, innovative drug preparations have high benefits and high risks. New drug research and development costs are high, the cycle is long, and the risk of uncertainty is high. According to research data from the School of Pharmacy of Tsinghua University, the average success rate of new drug research and development projects in the world is only 4.1%, and the whole process takes 10 to 20 years, excluding early research and development and management costs after the drug is launched, the average cost is as high as 873 million US dollars. However, opportunities and risks coexist, and the success of new drug development under high risks will also bring high returns. At present, the patent protection period of new drugs in China is 20 years, if it can pass clinical trials and drug registration, pharmaceutical companies will gain an innovation premium for a long time.

Precisely because pharmaceutical preparations are highly technical and innovative drugs have high return attributes, many companies will increase their research and development investment in pharmaceutical preparations, and gradually transform to innovative drug models to improve domestic and even global market competitiveness. In the field of pharmaceutical preparation processing, research and development companies will combine modern preparation technology with polymer materials or polymers to disperse drugs in special structures, resulting in innovative preparations that are different from traditional delivery routes.

Several new preparation processing technologies

Oral slow-controlled release technique

Oral slow and controlled release system is a new type of drug delivery system which develops rapidly in modern pharmacy and is widely used in clinic. Based on conventional dosage forms, the system uses slow control preparation technology to delay and control drug release speed, reduce drug toxicity, improve efficacy and reduce adverse reactions. Generally speaking, the release of oral slow-controlled release preparations is mainly completed by diffusion, corrosion, dissolution and penetration, and the dosage forms mainly include skeleton type, membrane control type, osmotic pump type and double slow-release type. For example, membrane controlled release technology is to treat tablets, particles, capsules, etc., with one or more packaging materials, so as to achieve the purpose of controlling the dissolution or diffusion rate of drugs. At present, the research on oral sustained-release drug preparations has become an important direction in the development of drug preparations. The 2020 edition of Chinese Pharmacopoeia also gives the latest guidelines for oral sustained-release, controlled-release and delayed release preparations.

Carrier drug delivery technique

Carrier drug delivery technology includes the research and development of long-acting injection microspheres (particles), nanoparticles, liposomes, implants and related pharmaceutical excipients. Among them, microsphere technology is to attach the drug in the polymer, forming a small spherical solid, with the function of preservation and stability of the drug effect, more convenient for patients to take medicine or injection anytime and anywhere, but the production process of microsphere technology is complex, the cost is high, and it is also the bottleneck that needs to be broken through. Polymer nanotechnology is a kind of synthetic and degradable polymer material. The drug carrier produced by this material is not only small in size, easy to take, but also has a non-volatile effect, which reduces side effects and improves bioavailability effectively. Liposome refers to bilayer spherical vesicles composed of phospholipids and other lipids. It encloses drugs in bilayer to form a miniature drug-carrying system, which can also reduce drug toxicity and improve the targeting and therapeutic stability of the preparation, and has broad application prospects.