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Discovery & Development Business Practice, Ingredients, Formulation, Standards & Regulation, Small Molecules, Drug Delivery, Technology and Equipment, Analytical Science, Trends & Forecasts, Dosage Forms

Dry Powder Inhaler Formulation Development

Dry Powder Inhaler Formulation Development

Dry powder inhalers are accepted as being complex drug products due to the interactions which occur between the active pharmaceutical ingredients (APIs) and excipients within the formulation and the way this then affects the efficiency of drug delivery by the inhaler device. Obtaining component specific particle size and particle shape distribution data can help with understanding the properties of the formulation as part of formulation or deformulation studies. This application note describes how the combination of automated image analysis with Raman spectroscopy in the Morphologi G3-ID allows the individual components present within a dry powder inhaler formulations to be independently characterized and compared.

Introduction

Within the pharmaceutical industry there has been a drive in recent years for better product understanding through increased product knowledge. Towards this end, the ability to measure the particle size of the active pharmaceutical ingredient(s) (API) in product blends and formulations has provided valuable insights into product efficacy, which has the potential for translation into cost savings. The particle size distribution (PSD) is a particularly important characteristic in the development and manufacture of oral and nasal inhaled drug products (ONIDPs), as it is the main determinant of whether the API particles will reach their intended destination and function as required. The most common method for performing this analysis uses manual microscopy and visual identification of the API particles within a blend dispersion. These analyses can be time consuming, subjective and inaccurate. This application note describes how the combination of automated image analysis with Raman spectroscopy in the Morphologi G3-ID can be applied to increase both the accuracy and robustness of these types of measurements by chemically identifying and isolating the particles of interest within a dry powder inhaler (DPI) formulation.

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