Publications, Pharmaceutical

Navigating the Development for Orally Inhaled and Nasal Drug Products

This article is a summary of an interview with Gemma Budd, Business Development Director at Nanopharm, where Gemma discusses strategies for successfully navigating the path from discovery to Investigational New Drug Application (IND) for OINDPs (orally inhaled and nasal drug products).

OINDPs (Orally Inhaled and Nasal Drug Products) are products used to treat respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and allergies and delivered to the respiratory tract through inhalation or nasal administration. This delivery method allows the drug to be directly delivered to the site of action in the respiratory system, which can lead to more effective and efficient treatment.

Download Gemma Budd's Interview "From Discovery to IND: Navigating the Development for Orally Inhaled and Nasal Drug Products (OINDPs)"
Author(s): Gemma Budd
10 May 2023

However, developing these products presents several challenges. These include formulation and manufacturing, device design and functionality, safety and efficacy, regulatory compliance, and market competition.

The formulation of OINDPs can be a complex process, as it involves developing a stable, effective and safe drug product that can be effectively delivered to the patient’s respiratory system. The manufacturing process also requires careful attention to ensure consistency in drug particle size and distribution, as well as maintaining the integrity of the drug product during manufacturing. The design of the device used to deliver the OINDP is crucial to ensuring proper delivery of the drug to the respiratory system. The device must be user-friendly, easy to operate, and capable of delivering the correct dose of medication to the targeted area. Additionally, the device must be designed to prevent contamination, clogging, or other issues that could impact drug delivery. Also, OINDPs must be safe and effective for patients to use. This requires extensive testing to ensure that the drug product does not cause harm to the patient, and that it delivers the drug in the proper amount to effectively treat the targeted condition. Their development requires compliance with strict regulatory requirements and meeting these requirements involves demonstrating the safety and efficacy of the drug product, as well as adhering to good manufacturing practices (GMPs) and other quality standards.

There are several types of molecules in the OINDP development pipeline. The development pipeline includes a variety of different molecules, including small molecules, proteins, peptides, and nucleic acids. Small molecules are typically used for the treatment of respiratory diseases whereas proteins and peptides are used for the treatment of diseases such as cystic fibrosis, nucleic acids are being developed for the treatment of genetic respiratory diseases.

So where should someone start in OINDP Development? Developers should start with a clear understanding of the disease to be treated and the specific needs of the patient population. This includes understanding the target site of action in the respiratory system, the desired pharmacokinetic profile, and the desired dosing regimen. Developers should also consider the technical requirements of the device, such as the size of the drug particles and the ability of the device to deliver the drug to the desired site of action. There are also dosing and formulations aspects to consider. The dosing and formulation of OINDPs are critical to their effectiveness and safety. The optimal dosing regimen will depend on the specific drug and disease being treated, as well as the patient population. Formulation considerations include the physical and chemical properties of the drug, such as its solubility, stability, and particle size. The formulation must also be compatible with the chosen delivery device. The choice of device for OINDP delivery is also important and influenced by a number of factors, including the desired site of action, the physicochemical properties of the drug, the dosing regimen, and the characteristics of the patient population. There are several different devices for OINDP delivery and the choice of device will depend on the specific needs of the drug and patient population.

The article concludes by saying that OINDPs are an important category of pharmaceutical products and the continued development of OINDPs has the potential to lead to more effective and efficient treatment of respiratory diseases.


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