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What makes Health Yuan's "Shutanlin", a generic drug, different?
Published Time：
2020-02-20
Inhalation therapy, recommended by domestic and international guidelines as a preferred treatment for obstructive airway diseases, is the mainstream clinical treatment method. However, due to the high barriers to the development of inhalation preparations, there are relatively few players in China with the ability to participate in research and development. In this peak competition, in April 2019, Health Yuan Group, with its first respiratory disease inhalation preparation to pass the consistency evaluation, and also the first new Class 4 registered and approved nebulized inhalation solution - Compound Ipratropium Bromide Inhalation Solution (Shutanglin), broke the long-standing technological monopoly of the original research product in China, becoming the leader in this peak competition. So, what is different about Health Yuan's Compound Ipratropium Bromide Inhalation Solution (Shutanglin)?
Stability is comparable to the original research product, with lower levels of related substances (impurities)
Compound Ipratropium Bromide Inhalation Solution (Shutanglin) adopts the currently internationally leading blow-fill-seal aseptic manufacturing technology. Strict quality control is implemented according to European and American quality standards. Drug stability tests show that the trend of related substances (impurities) is consistent with the original research product, and the product quality and stability are comparable to the original research product, with lower levels of related substances (impurities).
With the same administration time and dosage, the total amount of drug inhaled is comparable to the original research product.
Compound Ipratropium Bromide Inhalation Solution (Shutanglin) consists of ipratropium bromide and salbutamol, which can act on different targets in bronchodilation simultaneously, rapidly expanding the main and small bronchi. It features rapid onset, strong effect, safety, and convenience. According to the relevant regulations of the Chinese Pharmacopoeia and the European Pharmacopoeia, the particle size distribution of the nebulized aerosol of the inhalation solution is determined by measuring the fine particle dose to evaluate the aerodynamic particle size distribution of Compound Ipratropium Bromide Inhalation Solution (Shutanglin) and the original research product. The results show that the aerodynamic particle size distribution of ipratropium bromide and salbutamol is consistent with the original research product, and the total amount of drug inhaled is comparable to the original research product with the same administration time and dosage.
As the leader in this peak competition, "Shutanglin" is just the beginning. Currently, Health Yuan Group has more than 20 inhalation preparations under research and development. A series of upcoming inhalation preparations will also help Health Yuan become the winner of this peak competition.
Source: Medical Pulse Pediatrics
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