An interview with Ameet Sule, Director of Inhalation Product Technology Centre, H&T Presspart
Could you give our readers a little background on your professional life?
My entire career so far has been in the respiratory drug delivery market, with over 20 years’ experience encompassing the development of metered-dose inhaler (MDI) components, formulations, analytical methods and drug products.
I am a post graduate with a Master’s Degree in Analytical Chemistry from the University of Mumbai. I began my career in the pharmaceutical industry with a number of junior positions in the respiratory drug field. In 2001 I became Head of Aerosol Development at Cipla, India’s leading pharmaceutical company in the respiratory field, where I was in charge of a team developing MDI products. After 17 years at Cipla, I then left to join Lupin, another large Indian pharmaceutical company, as Director of Pulmonary research where I was in charge of the development of MDI products.
In 2013, I joined H&T Presspart as the Director of their Inhalation Technology Product Centre (IPTC) which is based at our purpose-built laboratory. In addition to developing new devices, my team works closely with customers around the globe understanding and mitigating the front end development challenges of new and generic products for inhalation drug delivery.
How important were the skills and knowledge that you gained during your time within the pharma industry to the work that you are doing now?
We’re a key primary packaging supplier of MDI components to the pharmaceutical industry. Being associated with the pharma industry and developing MDI products allowed me to make an easy transition. MDI’s are complex products and the role of the drug formulation and the compatibility with the device is of equal importance.
I believe my experience of handling different pMDI products has been the key to bringing new knowledge to H&T Presspart. Understanding the performance characteristics of each primary packaging component such as can, valve, and actuator along with the formulation of drug, excipients and propellant is important. The analytical experience of testing and handling these complex products from a performance side has made it useful for developing new products such as Plasma canisters. It has also helped our team to understand the customer better, as well as market requirements.
Who are your traditional type of clients and what makes the organisation so well placed to service partners within the cannabis industry?
Traditionally, our clients are pharmaceutical players in need of high precision components for inhalation products, with our main focus centred on metered-dose inhalers and dry powder inhalers.
Our components are supplied to 85% of the world’s MDI’s so our client base is very much global. We supply to every continent and our customers range from the multi-national ‘big pharma’ corporations right down to regional customers who may service a specific market like Bangladesh or Argentina. It is a wide and varied client list.
We have seen interest in MDI’s increasing in the cannabis market and we are already supplying components to a number of customers in the USA and Canada. We also have a number of development programmes ongoing with clients as far away as South America and Australia.
We’ve been supplying MDI components for over 50 years and produce over 800 million of them every year so we like to think we know a thing or two about developing MDIs. As well as the components, we have our Inhalation Product Technology Centre (IPTC) which can offer product performance support with analytical services for devices with tests such as spray pattern testing, whilst supporting our customers in selecting the right components.
Metered-dose inhalers already have regulatory approval with bodies such as the FDA and MHRA, so they already meet all of the regulatory requirements and the challenges the cannabis industry could face in the future. We also find a lot of customers need support with formulation development and contract manufacturing and filling from small scale through to industrialisation. We have a strong network within the industry, enabling us to assist our customers in finding the right industry partners to support their needs.
The cannabis industry needs market experts for inhalation products with a wide understanding of all relevant componentry and who supplies them. Additionally, we can support our clients in bringing a product to the market, which is accepted by all national authorities in regards to its componentry (FDA, MHRA, etc. approved devices). We understands the rules of the inhalation market and can support its customers in many ways to reach their goals quicker and efficiently including laboratory, quality, regulatory and industrialisation support.
Ensuring appropriate delivery mechanisms for products and devices – both within the medical and recreational cannabis industries – is vital for patients and consumers. A lot of your focus is around non-combustible inhalation; what is the efficacy behind inhalation delivery over other mechanisms? And is this method best suited for some type of products over others?
Metered-dose inhalers have been around for 50 years and are tried, tested and trusted devices for delivering drugs to the lungs.
The key focus for a medicinal product is safety and efficacy. This is demonstrated not only through rigorous testing during product development, but also supported by large amount of clinical data prior to regulatory approvals around the world.
Over the years there have been some studies performed and research articles published demonstrating that the MDI is an alternative for the oral administration route and an option for reliable and safe application of medical cannabinoids. For example:
1) Pascale Meyer, Manuela Langos, Rudolf Brenneisen 2018 research article Human Pharmacokinetics and Adverse effects of Pulmonary and Intravenous THC-CBD formulations.
2) Millar, S. A., Stone, N. L., Yates, A. S., & O’Sullivan, S. E. (2018). A Systematic Review on the Pharmacokinetics of Cannabidiol in Humans. Frontiers in pharmacology, 9, 1365)
Unlike other devices such as vape pens, MDIs ensure a metered dose, with the user receiving the exact amount of drug every time. MDIs ensure a quicker onset of action and a higher bioavailability with lower doses is also possible. MDIs can also deliver both suspension and solution formulations. MDIs are also a closed system and there is no refilling needed, unlike vape pens, meaning there is no danger that a patient can misuse the device. Due to there being no uncontrolled chemical reaction within an MDI, there are no harmful side effects.
Metered-dose inhalers do not need power or a battery and no combustion or heating is required. The MDI is just a pressurised system like any household spray, making the device cost-effective and less complex than other devices on the market. With a little bit of training it is very easy to release the dose, making the device extremely easy and quick to use. The biggest benefit is the portability of the device. MDI’s have a shelf life of around 2 years, depending on the formulation.
For business owners that are looking to develop new products and devices, what advice would you give them? What recommendations would you have around research, due diligence and partnering with specialised organisations?
The cannabis market has already seen a number of deaths attributed to the unregulated use of vape pens for cannabis. It is important that any customer looking to manufacture a device finds a trusted supplier. Manufacturers with appropriate accreditations such as ISO and Good Manufacturing Practice (GMP) are always good indicators for quality. Companies that are used to dealing with the regulated market and organisations such as the FDA and MHRA are also good bench marks. Find out what markets they already serve and the types of customers they cater to. If they supply the pharmaceutical industry then you know their products will meet the highest safety standards.
Our advice is to team up with companies like ours, using their expertise, wide network and technological capabilities to help achieving your goal in a timely manner.
In regards to research, we have excellent contacts and partnerships across the cannabis market from universities and research companies through to companies developing cannabis products. The key is to find a good development partner, with the ability to innovate and develop formulation and device together, a consistent raw material source for CBD, THC ability to scale up and commercialise ensuring a stable supply chain.
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