Purity Pharmaceutical Research Institute was established in August 2012, with a construction area of approximate 4,500 square meters, a research and development team of several experts in inhalation drug field who had returned from abroad. Currently, there are more than 150 researchers. The cumulative investment in scientific research equipment has reached nearly 100 million yuan. During the past several years, the enterprise independently established an innovative drug research and development platform and R&D pipeline of innovative products such as dry powder inhalation, metered dose inhalation aerosol, nebulized inhalation solutionand nasal spray. It got rich experience in core technologies in drug design, prescription and process development and industrialization. And many of its products were approved for production. In future, the enterprise will focus on the research and development of generic drugs and improved new drugs for respiratory diseases, mental and neurological disorders, and build a technological city moat, achieve stable revenue and create enterprise brand through the use of advanced drug delivery technology and particular delivery device.

Four major innovation platforms

Particle Engineering Platform

      The inhalation drug delivery is designed to precisely and efficiently deliver drug particles (of micrometer or even nanometer level) to target organ. Therefore, for inhalation preparation, there are strict requirements on the properties of drug particles, and the particle diameter range, particle surface morphology, crystal form and crystal habit should be controlled precisely. The employees of Purity Pharmaceutical particle engineering platform established the “Top-down” particle micronization technology with air stream pulverization as a representative and the “Bottom-up” particle preparation technology with spray drying as a representative. The two technologies complement each other, comprehensively cover the requirements on particle preparation for different types of moleculars (small molecule, polypeptide, biological macromolecule) and different physicochemical properties (thermal unstablity, crystalline/amorphous form, etc.). The solid-state physical properties of inhalation preparation, such as particle size distribution, powder morphology, roughness, powder fluidity, specific surface area, surface energy and crystal form have direct impact on the stability and delivery characteristics of the preparation. The employees of Purity Pharmaceutical particle engineering platform established the laboratory with particle characterization technology for advanced solid-state characterization instruments such as scanning electron microscope, specific surface area analyzer, dynamic vapor adsorption analyzer, nanoparticle size analyzer, and laser particle analyzer. They developed cooperation with research institute on advanced characterization technologies such as solid-state nuclear magnetic resonance, microcalorimeter, and morphology-directed Raman spectroscopy.“

      The successful achievement of particle preparation technology and characterization technology on the particle engineering platform made it feasible to design and prepare drug particles with ideal solid properties based on the physicochemical properties and delivery requirements of drug. The technologies were widely applied in the research, development and production of multiple inhalation products of Purity Pharmaceutical.      

Advanced Delivery Technology

      Purity Pharmaceuticals focuses on the international leading drug delivery innovation, and has established a naso-brain drug delivery technology platform based on naso-brain pathway and a liposome delivery technology platform based on nano-based drug delivery technology.

Naso-brain delivery

The Nose-to-Brain Delivery Technology platform involves breakthrough in multiple interdisciplinary subjects, such as nasal mucosa cell model, the BBB cell biology evaluation system, in vitro bionic evaluation system of human nasal cavity 3D model, innovative nose-brain delivery device, nasal solubilization and infiltration promotion technologies, etc. The technology platform breaks through the physiological barrier BBB restriction on drug entry into brain, improves the efficiency of drug molecule delivery to olfactory area, and achieves rapid and efficient drug entry into brain. A CNS drug product based on the naso-brain delivery platform has submitted to NDA for application. And multiple projects are in preclinical study stage.    

Liposome lung targeted delivery

      Based on the existing nano-delivery technology, Purity Pharmaceuticals established a liposome technology platform for pulmonary delivery, to explore two leading application fields: 1) Liposome for Inhalation with drug release advantages such as improved efficacy and reduced toxicity, prolonged drug retention in lung, and breaking through the barrier of pulmonary endothelial cells; 2) Lung-targeted lipid nanoparticle (Lung-targeted LNP) nucleic acid drug delivery technology with the targets of precise lung targeting and efficient transmembrane delivery, a controllable lipid nanoparticle system with technologies of physiological charge regulation, active targeting modification, and microenvironment response to construct in vivo biological behavior. It breaked the conventional limitation that nucleic acid drug lipid nanoparticles are only delivered to liver and spleen, and achieved lung-targeted delivery of nucleic acid drug.

In-vitro in-vivo Correlation

     Inhalation preparation takes effect through local absorption (into lung or nasal cavity), and the prediction of in vivo and in vitro correlation is very difficult than that of oral and injectable dosage forms, therefore, the failure rate of human PK trial for inhalation preparation is high. In response to the worldwide technology challenge, Purity Pharmaceuticals established an international leading in vivo and in vitro correlation evaluation platform for inhalation drug through the development of in vitro evaluation technology based on inhalation drug release characteristics and pharmacokinetic (PBPK) model based on the physiological characteristics of inhalation drug absorption pathway.

     Purity Pharmaceuticals developed in vitro research methodologies that simulate in vivo release behavior of inhalation drug such as human artificial throat, high-precision breathing simulation, and dynamic dissolution, and independently developed a high-precision physiological characteristic pharmacokinetic (PBPK) absorption model based on the large amount of PK data in human study and in vitro study data accumulated by the company, and established a platform for in vivo and in vitro correlation evaluation for inhalation drug. The evaluation platform is used to accurately predict the in vivo pharmacokinetic behavior of inhalation drug, so as to guide the optimization of formulation and process of inhalation preparation, and improve the success rate of drug clinical study, and shorten the drug development period. From the day of establishment, the platform has successfully predicted the in vivo PK concentration-time curves of 3 inhalation products of Purity Pharmaceuticals, helped the products smoothly pass the bioequivalence tests. The platform supports generic drug, and provides human PK prediction and dose-finding study guidance for the research and development of improved new drug and innovative drug.(PBPK)

Innovative Drug Delivery Device Platform

      Purity Pharmaceuticals successfully established a multi-functional drug delivery device development platform with functions of CT simulation modeling, dynamic simulation of airflow, multi-functional device test, nasal spray device development, powder aerosol device development, and automated assembly through cross-over study on material, structure, mold, automation, ergonomics and other field. The enterprise developed a series of new devices such as 3D simulation model of human nasal cavity, prototype device for nasal-brain delivery, powder aerosol for inhalation device, and smart powder aerosol airflow monitoring device with the use of the platform.

      With the continuous in-depth exploration of the drug delivery device platform, the development expanded into the field of new-generation intelligent devices, to develop intelligent drug delivery device system composed of drug and medical device - sensor chip - cloud computing storage - mobile phone APP, to help solve the problem of poor clinical compliance of inhalation drug. The intelligent drug delivery device system has functions such as medication guidance, intelligent monitoring, and medical feedback to improve the effectiveness of chronic diseases management for respiratory and neuropsychiatric diseases, and offers patient a more intelligent, portable, and precisely controllable smart drug therapy solution.