Pharmaceuticals have long been predominantly produced in the form of pills, tablets, creams, unguents, syrups, powders and injectables. The aerosol form has proven its usefulness, effectiveness and versatility for the delivery of numerous active principles in many different health therapies ranging from metered dose inhalers (MDIs) for the treatment of asthma to topical applications.

Nevertheless, only a handful of companies around the globe are familiar with this technology. The complexity of aerosol filling technology along with regulatory changes banning the use of CFCs as propellants may have acted as a dissuasive factor, preventing many companies from adopting aerosol delivery as an alternative to traditional forms and as a way to increase their product portfolio.

The manufacture of aerosols deals with a series of factors that are practically unknown in the pharmaceutical industry, such as (among others):

• Handling of propellants
• Assembly of a 3 component pressurized device (can, valve & actuator)
• Stabilization of API dispersion and suspension in the propellant matrix
• Compliance with standards regarding extractables and leachables from the valve gasket
• Compliance with dosage
• Dosage stability
• Spray pattern and particle size

Coster has developed an integrated solution for clients wishing to expand their product portfolio with aerosols. Its vast experience in developing solutions for the aerosol industry and close association with technical, formulation and regulatory pharmaceutical specialists makes Coster the ideal partner for pharmaceutical companies seeking to develop aerosol versions of their products.

Integrated Solution Model

The model is based on the integration of the following four cornerstones:

1. Aerosol Filling Technology

With more than 50 years’ expertise in providing solutions for the development and manufacturing of aerosol products, Coster is the sole company in the industry able to supply components together with filling equipment and formulations. The company is one of the most important players in the production of aerosol valves and actuators and, at the same time, a renowned manufacturer of filling lines and auxiliary equipment for the aerosol industry.

2. Aerosol Pilot Plant

Coster has installed a new Pilot Plant near Milan, Italy, for the production of aerosols. The new facility is ideal for experimental runs, pilot lots, process validations and training programs. On request, highly trained staff will supervise these activities. Coster experts support clients throughout the process: from the early stages of product development to formulation suggestions, from select-ion of appropriate packaging components and performance of compatibility tests to assistance in developing turn-key projects for special applications.

3. Formulation support

Thanks to an established association with technical experts in pharmaceutical formulations and specific industrial operations, Coster helps clients to develop a wide range of products, from standard cosmetic products for personal care (deodorants and antiperspirants) and “cosmeceuticals” (anti-aging, anti-cellulite, sun care and sun tan products, among others), to topical applications (anti-inflammatory, anti-mycotic, pain or burn relievers) all the way to the most sophisticated products such as life-savers for treating asthma symptoms or preventing attacks.

4. Regulatory and patent support

A group of experts stands ready to help Coster clients with regulatory and patent issues for the launch of their aerosol products and support them in the product certification process.

This combination of a solid expertise in aerosol manufacturing coupled with formulation and regulatory consultancy services makes Coster the ideal partner for pharmaceutical companies looking for product diversification, line extensions or new product launches in the form of aerosols.