Pharmatec Solutions

Focused On Innovation And Sustainable pMDI Manufacturing Processes

About Us

Pharmatec Solutions Ltd (PSL), is made up of respiratory technical experts with over 200 years of combined experience working with the world’s largest pharmaceutical companies and component suppliers, specialising in the development and manufacturing of respiratory products.

Millions of patients globally use pressurised metered dose inhalers (pMDIs) to treat asthma and COPD, and it is vital that these patients retain access to these devices. It is predicted that by 2025 there will be 2.5 billion pMDIs manufactured.  Pharmatec Solutions Ltd is committed to defining the next phase in the handling of low global warming potential (GWP) propellants ensuring continued patient access.

We have already undertaken significant work through collaboration to develop a simplified pMDI filling process by accurately measuring the quantity of drug required in a canister. This new powder filling process is equally suitable for any propellant.

Support throughout all stages of your project wherever you need it

PSL has the expertise and capabilities to support your project from Research and Development (R&D) through all stages to commercial manufacture. By supplementing our core team with trusted partners, PSL has the knowledge and resources to ensure your project is fully delivered.

Although the core team is kept small by design, our partnerships increase the lease of knowledge, expertise, capability, and resources to put together teams to support Research and Development (R&D) through all stages to commercial manufacture.

Boy using sustainable pMDI Manufacturing product

Introduction of 152a

With the introduction of low carbon footprint propellants, PSL has worked with a partner specialising in the handling of flammable gases to complete the design of a pilot and commercial facility to handle 152a.

This includes system design and zoning, carrying out risk assessments, FMEA, HAZOP and HAZID processes, and ensuring compliance with DSEAR- more information can be supplied upon request.

Working with a number of Contract Development Manufacturing Organisations (CDMOs), PSL is supporting the transition of current pressurised multi-dose inhaler (pMDI) formulations to next-generation low-carbon footprint propellants (152a and 1234ze) and the development of new pMDIs.

Formulation Development

PSL has worked with component suppliers and manufacturing companies to provide an invaluable skill-set focusing on the complex development of new formulations for respiratory products and developing programmes of work to reformulate current products into next generation propellants.

These programmes include the design of experiments (DOEs) to study the impact of new propellants on component constituent parts; for example; gasket materials within pMDI valves, the need for coated cans, purging, and excipients on formulations

Process Improvement

Once a product is launched, an area that companies historically disregard is the cost of goods and overall supply chain efficiency. This is an area where PSL has a high level of expertise.

We partner with black belt and lean manufacturing experts who can offer the ability to carry out value stream mapping to identify bottlenecks within the supply chain delivering solutions and support for continuous improvement.

VSM gives businesses an organisation-wide perspective on lean project management from the current state to visualising the future state design to improve project management.

In 2022 PSL has been supporting a multinational pharmaceutical and biotechnology company with the following process improvements:

  • Current State Walkthrough
  • Identification of undesirable effects (UDEs)
  • Future State Design & Conclusions
  • Increasing deliverables
  • Efficient decision & action-making in governance
  • Flow Stream Capacity Increase
  • Project Management Support

Drug Delivery to the Lungs Conference

PSL are attending the DDL (Drug Delivery to the Lungs) premier international conference, covering all aspects of respiratory drug delivery at the Edinburgh International Centre, from 7th – 9th December 2022.

Examples of data generated will be displayed at 16 Gerallt, inside the Edinburgh International Conference Centre. Visit the Harro Höefliger exhibit at booth 239 for more information.

Further information and data generated using the Powder Fill Process.

Dry Powder Fill Poster 2022

Download .PDF

Assessing the adaptability of bench scale dry powder technology for filling of a pMDI can with a high fill weight API
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Dry Powder Dosing Poster 2022

Download .PNG

Dry powder dosing studies of high and low dosage APIs
Download

DDL Conference Paper 2022

Download .DOC

Assessing the adaptability of bench scale dry powder technology for filling of a pMDI can with a high fill weight API
Download

Innovation

PSL has a culture of innovation. Our team is always looking to find ways of improving the way that pMDIs are manufactured.

Inhaled medication is the cornerstone in the treatment of patients across a spectrum of respiratory diseases, including asthma and chronic obstructive pulmonary disease.

The benefits of inhaled therapy has long been recognised but the most important innovations have occurred over the past 60 years, beginning with the invention of the pressurised metered dose inhaler.

The introduction of low Global Warming Potential (GWP) in Pressurised Metering Dose Inhalers (pMDI) has brought an ideal opportunity to rethink manufacturing.

Most development work on new formulations is carried out on a laboratory bench by using open cans placed on a balance and loading powder into the can using a spatula. This is then gassed with a propellant of choice.

With significant improvements in technology and the development of inline measurement systems, this simple method of filling has now been successfully industrialised.

A number of formulations have now been filled and are on stability, with early results equivalent to suspension-manufactured formulations.

PSL is currently developing this process with Harro Höefliger, a world leader in developing powder handling systems. Equipment is now available to deliver accurate, repeatable doses of powder directly into the canisters at pilot scale through to commercial scale manufacturing.

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