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Pharma Focus Asia Patient-centric Drug Delivery

LONNIE BARISH, VP, Business development and marketing, Bora

Contract manufacturing leaders offer their insight into drug delivery innovation and development.

What’s on the horizon for patientcentric drug delivery?

As more of the world reports better access to healthcare, the demand for safe effective therapeutics of all kinds will continue to escalate. This broad global acceptance of pharmaceutical based healthcare has accelerated the development of more sophisticated medications to treat the unmet needs of an increasing number of patients.

Conventionally, the market for all pharmaceuticals has been dominated by North America, followed closely by Europe. However, with an increasingly ageing population and growing spending on healthcare per capita, demand for pharmaceuticals in the entire Asia-Pacific region is expected to see rapid, significant growth for the foreseeable future.1

Asia Times reported in 2019 that the market for pharmaceuticals in China was set to reach US$161 billion, taking a 30 per cent share of the global market.
During the 2019 World Innovators Meet, Fu Xudong, senior vice-president of Bristol-Myers Squibb noted that China has emerged as world’s second-largest pharmaceutical market, following the United States.2

Dose delivery in development Oral Solid Dose (OSD) formulations continue to lead the market as a preferred dosage form. According to the US FDA Center for Drug Evaluation and Research (CDER), of the 38 small molecule drugs approved by the agency in 2019, 26 (68 per cent) were OSDs (19 tablets and 7 capsules).3

Demand for topical pharmaceuticals, another growing and patient centric drug delivery modality, is projected to reach US$129.8 billion by 2025 from US$95.2 billion in 2020, at a compound annual growth rate of 6.4 per cent during the forecast period. MarketsandMarkets points out that growth in this market is being driven by the increasing prevalence of skin and soft tissue infections, eye diseases emergency treatments for burns.4

Pharmaceutical development and innovation is coming from both drug developers and their contract manufacturing partners. Pharma is relying more and more on external partners to deliver the solutions they need to deliver their formulations and explore the new modalities, personalised genetic therapeutics and chemistries being introduced.

Pharmaceutical development and innovation is coming from both drug developers and their contract manufacturing partners. Pharma is relying more and more on external partners to deliver the solutions they need to deliver their formulations and explore the new modalities, personalised genetic therapeutics and chemistries being introduced.

To gain better insight into drug dose delivery technology trends Pharma Focus Asia invited leadership from three contract development and manufacturing organisations (CDMOs) serving the Asia-Pacific market for their input and perspectives on what is on the horizon for drug delivery.

Complex OSD systems for patient-centric dose control

As more of the world reports better access to healthcare, the demand for therapeutics has seen a significant increase. This has prompted the development of medications to treat and/or cure more rare diseases, as well as further development and exploration of new modalities, genetic techniques, and chemistries to make better-performing drugs for more people.

Personalised medicine is a prominent trend in pharmaceutical development and is increasingly being applied in new and innovative ways. The techniques involved provide deep insight into different patient populations and the pharmacokinetic and pharmacodynamic effects of various drugs. As a result, health professionals can be more selective in their choice of pharmaceutical products for their patients, taking into consideration their efficacy in certain subsets of the population.

This growing trend is likely to prompt the development of even more complex but still functional drug forms. This includes the combination of APIs for related disease states and deploying them in bilayer/tri-layer tablets and more sophisticated combination products.

With patient groups responding well to oral medications that allow easy administration, require fewer doses to be effective, and reduce or eliminate unpleasant side effects, OSD delivery remains the most popular route for administering drugs.

Patient friendly OSD strategies

Drug developers looking to enhance patient dose compliance can explore and utilise these complex patient-friendly OSD strategies through two main avenues:

Fixed-dose Combinations (FDCs), modified release single-capsule forms
Multi-unit Particulate System (MUPS) tablet designs

MUPS, a versatile technology combining proven pelletisation and tablet delivery modalities offers process efficiencies and by design, patient-friendly attributes compared to capsules. This technology is not new but is growing in popularity to control dose frequency and side-effects.

This delivery allows new modified-release profiles and the dosing precision pharma needs for its advanced formulations and potent, combined APIs. It is essentially a successful method of getting multiple APIs to ‘play nice together’ to create the complex but functional drug forms initiated by the push for personalised medicines.

As the demand for personalised/precision medicine grows it is evident these strategies will play an important role in developing the effective patientfriendly pharmaceuticals that society is demanding now to meet the future of healthcare.

Novel drugs need oral delivery to support patient-centric goals

Highly potent novel OSD drugs have gained popularity. At Metrics, our seasoned scientists are experts in supporting clients with their highly potent active pharmaceutical ingredient (HPAPI) formulation and development projects. Our characterisation capabilities combined with key insights gained over many years of experience, ensure that the containment and handling practices of any HPAPI project remain aligned.

The demand for HPAPIs has increased mostly because of the rapidly expanding oncology sector. As technology evolves and more oncolytic therapeutics are conceptualised, many companies turn to CDMOs to develop and produce their HPAPI drug substance and drug products. Because of the complexity and hazards involved in producing these drugs it is often easier to outsource this process to a team with a trusted track record and the installed containment technologies to effectively handle these products.

Manufacturing HPAPIs in-house requires major investments in contained development, production facilities, equipment and trained personnel who are certified to handle potent compounds. There are also many regulatory restrictions involved in handling potent drugs due to their hazardous characteristics and risk to the environment, patients, and manufacturing personnel.

Whilst some pharma companies do have in-house HPAPI capabilities, they are often at commercial scale. Yet, most contemporary needs for HPAPIs tend to be small batch sizes due to the specificity of the medication being produced. This means companies have had to partner with qualified outsourcing companies that are set up to handle smaller batches.

Key components in successful HPAPI operations

While there are a wide range of players now offering approaches to developing these drugs, not all CDMOs are equipped to properly handle HPAPIs. When looking for a partner, it is critical to first consider whether they have the proper equipment, facilities, and infrastructure to handle your HPAPI based on its known potency and health and safety hazards. Discuss the various risks associated with different unit operations and scales and be sure your CDMO can articulate a suitable plan to mitigate those risks and ensure they will be adequately addressed through the scale up process and commercialisation.

Engage development partners earlier for better patient centric delivery solutions

Asia, as well as pharmerging markets around the world are demanding more pharmaceuticals and more from pharmaceutical developers than ever before. All drugs, no matter what the route of administration, have to do more than ever. They have to be safe and effective and above all designed to suit the needs of the patient.

Topical formulations are inherently patient friendly

Most of the pharmaceutical market is dominated by oral or intravenous dosage forms. For some drugs, these conventional options for delivery are not possible due to drug instability, inability to get the drug to the target site, or systemic side effects. As patient expectations continue to rise, so does the requirement for pharmaceutical companies to develop more ‘user- friendly’ dosage forms.

This includes those that positively impact their health while integrating seamlessly into their lifestyles. This is especially important with topical formulations as the cosmetic and aesthetic properties are a critical aspect as patient compliance is often driven by the ease of use and the application experience. At MedPharm, the end user’s opinions and preferences are crucial from the start and are incorporated into the target product profile we establish with our clients from the outset.

A major trend that has impacted drug dosage forms is the rise in the use of complex entities known as biologics. These have brought their own challenges that has led to the need for new solutions in terms of packaging, analysis, delivery and stability. Research carried out with MedPharm’s experts challenges existing theories on topical delivery of these macromolecules and demonstrates that some aptamers can penetrate skin and remain active despite their large molecular weight (20k Daltons). This research offers hope for the discovery of new treatments for difficult-to-treat dermatological diseases.

There are multiple benefits associated with partnering with an expert for specialist dosage forms such as topical products for skin, eye, airways or mucosal membranes. To facilitate optimum formulation development unique knowledge and experience are required, something that most development companies lack in-house. Specialist contract developers like MedPharm possess an in-depth understanding of what it takes to get a product to market whether it is a new chemical entity, a re-purposed drug for a new indication, an OTC product or a generic. As a result, we expect to see a continued rise in outsourcing as the topical drug delivery market continues to advance.

One thing all three contributors agree on is that the more complex the dose formulation or delivery mode, the more it makes sense to introduce it as early as possible to development partners. The efficient development of a safe, effective oral or topical medication hinges on so many things, but it is clear that if patient-centricity issues aren’t addressed it will likely never reach patients successfully.

References:

1. http://www.pharmabiz.com/NewsDetails.aspx?aid=121681&sid=21
2. https://asiatimes.com/2019/12/chinas-pharma-marketpoised-to-hit-us161-billion/
3 https://www.fda.gov/about-fda/fda-organization/centerdrug-evaluation-and-research-cder
4 https://www.marketsandmarkets.com/PressReleases/topical-drug-delivery.asp

--Issue 41--

Author Bio

LONNIE BARISH

Lonnie Barish is the VP of Business Development and Marketing for Bora Pharmaceuticals USA. He is a seasoned Sales, Marketing, and Business Development Executive with over 25 years of experience in creating and managing Sales and Marketing teams. Lonnie’s strength lies in building solid relationships with his internal and external customers/ partners that create mutually beneficial opportunities. He has held senior sales roles at CMOs and CROs including ICON, AAIPharma, Cytovance and WellSpring.

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