Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases of the respiratory system. are on an upward trend. These diseases are characterized by long-term and recurrent attacks, which have caused a huge medical burden to the society and the patient’s family. Inhalation preparations have irreplaceable advantages in the treatment of pulmonary diseases. They are a combination of medicines and devices that deliver drugs in the form of aerosols to the respiratory tract and (or) lungs through a specific device to achieve local or systemic treatment. These include inhalation powders, metered-dose inhalation aerosols, liquid formulations for inhalation, and inhalation sprays. Due to the high technical barriers to the research and development of such generic drugs, not only the prescription process design, but also the influence of factors such as patients and devices must be considered. In recent years, this journal has published research on inhaled preparations research progress, key points of research and development, guiding principles, regulatory challenges, market scale, etc., in order to provide assistance for domestic enterprises to develop inhaled generic preparations, popularize the application scope of domestic inhaled preparations, and improve the quality of life of patients with asthma and COPD .
The following are some related articles published in China Pharmaceutical Industry Journal< /strong>
PART.01
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Lu Chenghao, Liu Ali, Wang Qingjuan, Feng Zhong, Zhang Guimin. Research progress of oral inhalation preparations [J]. China Journal of Pharmaceutical Industry, 2022, 53(02): 175-183.
Abstract: Oral inhalation preparations are aerosol generating devices with different principles and corresponding The drug-device combination product formed by the combination of drug forms is currently the first choice for the prevention and treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). Inhalation formulations are not only technically challenging to develop, but also difficult to use. This study summarizes the research progress of oral inhalation preparations in improving patient medication compliance, overcoming delivery dose limitations, controlling particle characteristics to improve aerosolization effect and expanding therapeutic fields in recent years at home and abroad, as well as the development of relevant regulations and guidelines. Innovations in processes, formulations, devices, standards and uses, with a view to providing a reference for innovative research on oral inhalation preparations.
https://mp.weixin.qq.com/s/Wd11QxE0BhgNQCWmgNKM6Q
PART.02< /p>
Feng Anjie, Li Lingjun. An overview of the key points of research and development of inhalation aerosols[J]. China Pharmaceutical Industry Journal , 2021, 52(11): 1429-1435.
Abstract: Inhalation Aerosol (MDI) It has irreplaceable advantages in the treatment of lung diseases and is widely used worldwide. At present, there are many varieties of inhaled aerosols, but most of the domestic studies are in vitro consistency evaluation of generic drugs, and there are few studies on innovative inhalation drugs and inhalation devices. MDI is more complex than traditional preparations, and three factors, including prescription, patient and device, must be considered in drug development. This study reviews the upgrading and transformation of MDI in recent years around these three aspects, with a view to expanding the application scope of MDI and improving delivery. Efficiency provides a reference.
https://mp.weixin.qq.com/s/b9xE2gew_3kUr_Z2dn-Ulw strong>
PART.03
Zhou Xuan, Yu Yong, Hou Shuguang. Science of Oral Inhalation Drug Bioequivalence Study Foundation and Regulatory Challenges[J]. China Pharmaceutical Industry Journal, 2021,52(09):1131-1141.
Abstract: Oral inhalation pharmaceutical preparations are a combination of drugs and devices, and are the first choice for the treatment of asthma, chronic obstructive pulmonary disease (COPD) and other respiratory diseases. The development of inhaled drugs is not only technically challenging, but there are also debates and differences in European and American regulatory requirements. This paper systematically compares and analyzes the European and American regulatory guidelines for the development of inhaled generic drugs from three aspects: in vitro pharmaceutical research, in vivo pharmacokinetic (PK) research and pharmacodynamic (PD) research, and discusses its scientific basis. The in vitro pharmaceutical research of inhaled generic drugs and original drugs is the prerequisite for the consistency of preparations; PK research is sensitive and objective, which can further ensure the consistency of inhaled generic drugs; the significance and necessity of PD research are controversial and need to be further confirmed. The R&D and application of inhaled generic drugs in my country should be based on the guiding principles issued by the Center for Drug Evaluation (CDE) of the State Drug Administration, and scientifically design in vitro and in vivo evaluation methods in combination with drug properties, preparation categories and the latest regulatory developments.
http://www.cjph.com.cn/CN/abstract/abstract2886.shtml#abstract_tab_content span>
PART.04
Li Shuai, Chen Guiliang. FDA Guidelines for Specific Drug Development for Generic Drugs for Inhalation Summary Analysis [J]. Chinese Journal of Pharmaceutical Industry, 2021, 52(08): 999-1009.
Abstract: By combing 34 specific drug guidelines for generic drug development of inhalation preparations issued by the US FDA, a summary of inhalation powder aerosols, inhalation aerosols, inhalation sprays, and inhalation suspensionsIn vitro bioequivalence studies, pharmacokinetic studies, pharmacodynamic studies, clinical endpoint studies and device comparison methods used in the development of generic drugs for inhalation solutions, compared the development methods, trial designs, primary study endpoints and equivalence of each variety The differences in standards provide a more targeted reference for the development of generic drugs for inhalation preparations.
http://www.cjph.com.cn/CN/abstract/abstract2867.shtml
PART.05< /strong>
Dong Zihao, Wu Wenzhe. Quality by Design (QbD) in the development of dry powder inhalers Application [J]. Chinese Journal of Pharmaceutical Industry, 2021, 52(02): 151-162.
Abstract: Dry powder inhalation has the advantages of avoiding first-pass effect, high bioavailability and convenient administration. However, due to the high variability of powders, it is difficult to achieve accurate delivery of drug doses. Moreover, as a dosage form of a drug-device combination, the formulation and device design of dry powder inhaler also need to be carefully considered. Applying quality-by-design (QbD) tools including risk analysis, experimental design, process analysis techniques, and predictive science can effectively reduce powder variability in dry powder inhalers, improve lung deposition rates, and ultimately improve patient quality of life. improve. At the same time, each researcher must have the ability to statistically consider the pulmonary delivery efficiency of dry powders. This paper reviews the advantages of QbD theory and tools in the development of dry powder inhalers, in order to provide references for future product development.
http://www.cjph.com.cn/CN/abstract/abstract2751.shtml
PART.06< /strong>
Li Dong, Li Shuai. Oral inhalation preparations for asthma and COPD Comparison and Analysis of Listing Pattern and Scale [J]. Chinese Journal of Pharmaceutical Industry, 2020, 51(12): 1602-1610.
Abstract: In recent years, the incidence of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) has increased year by year. Orally inhaled drug products (OIDPs) have unique advantages in the treatment of asthma, COPD and other respiratory diseases, and the market scale is gradually expanding, and now the global scale has reached tens of billions of dollars. There are high technical barriers to innovation or imitation of such preparations, medicines and devices. Due to the different market strategies and patent terms of pharmaceutical companies, different countries and regions around the world have different market patterns and scales of OIDPs. In August 2019, the Center for Drug Evaluation of the State Drug Administration issued the “Guidelines for the Pharmacy and Human Bioequivalence Research of Oral Inhalation Generic Drugs (Draft for Comment)”, which stipulates the guidelines for inhalation powder aerosol, inhalation aerosol Therefore, this paper summarizes and compares the market conditions of inhalation powder, inhalation aerosol and inhalation suspension in the United States, the European Union, and China, and at the same time according to their listing and sales, analyze the market structure and scale, in order to provide reference for the R&D and market layout of OIDPs manufacturers.
http://www.cjph.com.cn/CN/abstract/abstract2733.shtml
The following are medical geographies Published related articles
Asthma drug market “one super-many strong”, research and development The field battle is in full swing!
Abstract: Bronchial asthma (referred to as asthma) is the most common chronic One of the non-communicable diseases, about 300 million people worldwide are suffering from asthma. The global incidence of adult asthma is about 4.3%, and the incidence varies widely in different regions. The incidence is higher in developed countries, such as 21% in Australia, while in developing countries, such as China, the incidence of asthma is only 0.2% . This may be due to the relative scarcity of medical resources, resulting in far underestimated asthma incidence. Severe asthma can lead to disability, reduced quality of life, and even death in children and young adults.
The data in this article are all from the PDB drug comprehensive database (pdb.pharmadl.com) and the CPM new drug development monitoring database ( cpm.pharmadl.com).
https://mp.weixin.qq.com/s/B8IVunPRyI3Gd6Y2MmGIeQ
Source: China Pharmaceutical Industry Journal
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