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Article / Jun 01, 2015

Developing an Orally Inhaled Dry Powder Formulation

Pharmaceutical Technology, June 2015

Developing an Orally Inhaled Dry Powder Formulation - A Complex Itinerary and a Technological Challenge

The delivery of an orally inhaled API to the deep lung can be performed using different drug-delivery platforms, such as nebulizers, pressurized metered dose inhalers (pMDI), and dry powder inhalers (DPI). DPIs are increasingly becoming a more important drug delivery option and are expected to hit double-digit figures, reaching global sales of $31.5 billion in 2018

DPIs are conventionally formulated using a carrier-based approach, in which the API is size-reduced until it reaches an inhalable particle size and is further blended with a lactose carrier to enable dose metering and to improve powder flowability and dispersibility. Even though this formulation approach is the most commonly used, it presents several drawbacks. To overcome the limitations, as well as to address the renewed interest in pulmonary delivery of biotherapeutics and other advanced therapies, several alternative particle engineering approaches have been devised over the years, such as the production of composite particles by spray-drying where the API is embedded in an excipient matrix.

Although the development of a DPI seems straightforward, it is a complex area that integrates multiple fields of knowledge. In a general way, the success of a DPI produced using a carrier-based formulation approach will be determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance. In this article, Gonçalo Andrade, business development manager at Hovione, spoke to Pharmaceutical Technology about the key considerations when developing an orally inhaled dry-powder inhalation formulation.

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The global inhalation contract development and manufacturing organization (CDMO) market is projected to grow from USD 9.13 billion in 2025 to USD 16.68 billion by 2035, reflecting a compound annual growth rate (CAGR) of 5.7% during the forecast period. This growth is driven by the increasing prevalence of respiratory diseases, advancements in inhalation drug delivery technologies, and the rising demand for outsourced manufacturing services in the pharmaceutical industry. The inhalation CDMO market has emerged as a pivotal segment in the pharmaceutical contract development and manufacturing industry. With a rising demand for inhaled therapies for conditions like asthma, COPD, and cystic fibrosis, companies are increasingly outsourcing drug development and production to specialized partners. Inhalation CDMO services cater to both large pharmaceutical corporations and small biotech firms, offering expertise in formulation, device compatibility, regulatory support, and scale-up manufacturing. This market is gaining traction due to the complexity of inhalation drug delivery, which often requires niche technical capabilities and specialized equipment. Outsourcing to an inhalation CDMO allows drug developers to reduce time-to-market while ensuring quality and compliance with global standards. (...) Top Companies Several players dominate the inhalation CDMO market through technological expertise, global reach, and service portfolio diversity: (...) Hovione – Offers particle engineering and inhalation development, with a focus on dry powder inhalers. (...) These companies are continually investing in facilities, talent, and technology to meet evolving customer needs in the inhalation CDMO market.   Read the full article on Pharmiweb.com        

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