Inhalation drug R&D platform

• Inhalation preparations are an important part of complex preparations. This type of preparation can be absorbed quickly, reduce the dosage of the drug, and reduce the adverse reactions of the drug. It can be used for local and systemic administration. It is used in innovative drugs, improved new drugs and generic drugs.Inhalation formulations are unique in terms of technology development, review and approval.  It is necessary to comprehensively consider the technology, quality control, drug delivery device and production of the final product.  Medicilon is familiar with the development process and has extensive R&D experience of various inhalation formulations, especially in the field of DPI, nebulizer and nasal spray.  The R&D are fully integrated with the requirements of domestic and foreign policies, regulations and guidelines.

Type of Inhalation Preparations

• Inhalation preparations include several types:
  Dry Powder Inhaler，DPI；Dry Powder Inhaler (DPI) refers to the formulation of solid micronized raw material medication alone or mixed with a suitable carrier, using a special dry powder inhalation device for the patient to inhale the aerosolized medicine to the lungs.Nebulizer；Nebulizer refers to a drug delivery device to administer medication in the form of a mist inhaled into the lungs.Meter Dose Inhaler，MDIA Metered Dose Inhaler (MDI) is a device that delivers a specific amount of medication to the lungs, in the form of burst of aerosolized medicine that is usually self-administered by the patient via inhalation.
  

Inhalation Preparation Quality Study

• In addition to the conventional physical and chemicalproperties , the quality of inhaled formulations also includes some special indicatiors:
  Aerodynamic Particle Size Distribution, APSD；Fine Particle Dose，FPD；Delivered-Dose Uniformity, DDUDelivery Rate and Total Delivered
• These studies require the use of proprietary analytical equipment.  Medicilon's equipped state-of-the-art equipment could fulfill the quality research and in vitro evaluation of various inhalation formulations.
  New Generation Impactor BRS 2100 Breath Simulator from Copley Scientific;Particle Size Analyzer from Sympatec.

Inhalation Drug Safety Evaluation Platform

• Medicilon has finished a complete set of inhaled drug safety evaluations, including:
  Pharmacokinetic testTissue distribution testAcute Toxicity Test28-day repeated dose toxicity testStimulus testAllergy test
  At present, Medicilon has established a complete set of technology for inhalation administration, including:
  Intratracheal atomization administration, oral and nasal exposure administration, etc.;Administration to 5 species of rats, mice, guinea pigs, dogs, and monkeys;56-day long-term administration operation;4 hours of long-term administration, meeting the OECD administration time requirements;Powder and liquid drug aerosol generation system for powder and liquid drug delivery.

Drug inhalation pharmacokinetic and toxicological tests

• Due to the particularity of inhaled drugs, oral and intravenous drugs can be prepared in advance for administration. During the aerosol generation of inhaled drugs, the aerosol concentration, particle size and particle size distribution will fluctuate, so it is necessary to adjust the dose and particle size. During the drug administration process of animals, the aerosol concentration is regularly detected to obtain the dosage. In a cycle of administration, the frequency of regular detection of the aerosol concentration is very high.
  At the same time, the detection of particle size and particle size distribution is very important in the inhalation drug toxicity test. Inhalation drug has very strict requirements on the particle size of the aerosol. Only when the diameter is controlled between 1 and 4 microns can it be well absorbed by the lungs.
  Medicilon has accumulated a lot of experience in the research and development of inhaled drugs for many years. Before the test, we will conduct a preliminary exploration of particle size, concentration, and aerosol generation. During the experiment, aerosol concentration detection, temperature and humidity detection, oxygen/carbon dioxide detection and particle size detection are carried out regularly. During the experiment, there are many detection points and the detection frequency is high. During the inhalation and administration process, the state of the animals is monitored in real time. After the experiment, the animals will be carefully observed clinically, grossly dissected, and histopathological evaluation of various tissues of the respiratory system can be performed.

Features and Benefits of the Medicilon Inhalation Delivery Device

• Medicilon is equipped with aerosol inhalation and drug delivery equipment for small animals and large animals, including clean air generation system, aerosol generation system, real-time monitoring and control system for conventional gases such as temperature and humidity, oxygen, carbon dioxide, real-time sampling system, test product Concentration real-time adjustment system, etc.;It can carry out the inhalation and drug administration of more than 30 small animals and the inhalation and drug administration of 10 large animals at the same time.

Service Cases

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  Medicilon assisted the inhaled nanobody drug LQ036 getting approved for clinical use

  

  Medicilon assists Palaatu to obtain clinical approval for Class 1 new drug PA9159 for rhinitis

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FAQs

• What is the definition of inhalation formulation?

  Inhalation formulation refer to formulations in which a drug is delivered to the respiratory tract and/or lungs in the form of a mist through a specific device for local or systemic action.

• What are inhaled liquid formulations and inhaled liquid formulations include?

  Inhalation liquid formulation is a dosage form of oral inhalation formulation, which refers to the liquid formulation for nebulizer, that is, through the nebulizer to produce continuous aerosol solution for inhalation, suspension, etc.

  The main types of Inhalation liquid preparation include:
  • Inhalation solution. • Inhalation suspension. • Inhaled solution(the concentrated solution needs to be diluted before using). • inhalation powder(the sterile drug powder needs to be dissolved before using).

• 所有研究均在同一园区内实验室有序完成，切实保证实验进度和项目沟通的高效性，占据数据获取和评估的行业优越性。