The drug market has changed a lot over the last 10 years, particularly when it comes to the way medication is administered to either overcome challenges related to the drug substance or enhance useability and make it easier and more pleasant for patients to use. But what about the future? What does the next decade have in store for drug dosage forms?
An Industry on the Move
The last five to ten years have seen substantial changes across the pharmaceutical industry, many of which have had a significant impact on the dosage forms used for the administration of drugs.
The industry is being transformed by the growing trend of developing new, enhanced drug products based on established and widely used active pharmaceutical ingredients (APIs). Improved drug products with the same drug substance can deliver significant benefits, most importantly to their therapeutic effect, but also to manufacturing efficiency, cutting development timelines, and reducing costs.
This trend increasingly requires changes to the way drugs are administered in order to increase both their convenience of use and their therapeutic effect. More and more, we’ve seen established APIs repurposed for new indications requiring new administration routes, modified release, or fixed dose combination products, particularly following the advent of favorable regulatory pathways for known APIs, such as the FDA’s 505(b)(2).
In addition, the industry is seeing growing interest in the development of parenteral products. An important driver for this is the rise of biopharmaceutical products, especially given the current focus on vaccine development, as most of the treatments currently in development require parenteral administration in order to be effective.
Another key factor in the expansion of parenterals is the increasing interest in hospital care products. People are starting to realize that, while injection is less convenient than alternative routes, it is still an adequate administration route in a clinical environment. For serious indications, injectable dosage forms are sometimes the only solution, and as such, the development of convenient and reliable autoinjectors is being brought into focus.
Finally, local administration is another field that it is increasing in importance, due to its ability to deliver drugs directly to the target organ, while minimizing systemic exposure to reduce adverse side effects. Inhalation is a good example of such a route, due to its unique ability to target the treatment of respiratory conditions as well as its potential application for systemic effect.
Specialized drugs are also being developed for other local administration routes, including nasal, ophthalmic, otic, and vaginal, as well as parenteral formulations designed to be injected directly into the target organ.
Continuous Improvement in Dosage Forms
All of these developments are translating into rapid evolution for the dosage forms we use to deliver drugs to patients.
The inhalation device is an excellent example of this continuous improvement. Inhalers have been around for decades but, thanks to new technology and innovation, the new generation is easier for patients to use than ever before.
The same is true for injection devices. The development of modern autoinjectors have transformed the space, opening up the possibility for patients to administer these drugs themselves at home, without the need for professional help or supervision.
In addition, many technologies for modified release, such as coated pellets, initially developed decades ago have evolved to enhance useability creating drugs that minimize side effects, reduce dosage frequency and can even combine multiple APIs into one dose. As a result, they are fast becoming recognized as their own as a segment.
The Search for Dosage Perfection
The drive to deliver ever better drugs is meaning increased prominence is being placed on selecting the ideal dosage form early on in development. Great strides have been made in this area, but there is still a long way to go before we achieve this goal for one key reason – there is no single “perfect” dosage form, it necessarily depends on the needs of the API combined with what the patient requires and why.
The ideal dosage form should have broad applicability – one reason why tablets and capsules are so common. With tablets you can achieve so many different release profiles, including immediate release, modified release, orally disintegrating tablets, fixed dose combinations and many others. As a result, there is opportunity to adapt the formulation to the product requirements.
Changing Dosage Development Priorities
There are some dosage form characteristics that will always be important – these include: bioavailability; stability; and dose homogeneity.
However, as we look into the future, it is likely that drug company priorities for their dosage forms will change, or at least broaden. One key characteristic that is moving up the agenda with good reason is manufacturability. The cost of manufacturing and packaging make up a considerable part of the total cost of a drug and this is highly dependent on choices made in development. Failure to strike the right balance could impact profits, and limit patient access to valuable new treatments.
With this in mind, it is vital that drug companies begin to focus on the impact of dosage form on scale-up and commercialization as early as possible in their project. Both new and existing technologies can help to bring unique benefits that optimise the value of the product as well as its performance.
The Rise of User-Friendliness
Another dosage characteristic that is fast becoming a top priority is user-friendliness – how pleasant or easy the drug is for patients to use. Each formulation comes with its own challenge in this area. Oral formulations are in general user friendly in the sense that swallowing things is natural to humans, but attention needs to be paid to ensure that swallowing is not unpleasant due to the size, taste, or odor of the product.
Inhalation, on the other hand, is generally seen as less user-friendly as it is less natural than oral administration to most patients and, to achieve the right effect, it is important to use the device correctly and ensure the entire dose is administered. The major challenge here is to develop a device and a composition that limit the risk of an unskilled patient not benefiting from the intended effect from their medication.
For parenteral dosage forms, useability means different things in different contexts. When used by health care professionals, the user is very skilled, so concerns around incorrect administration are less of an issue. Still, valuable time can be saved by convenient products such as prefilled syringes. However, with self-administered injectables on the rise, it is becoming increasingly important to design autoinjector devices that untrained patients can use on themselves.
We can expect the need for useability to become ever more pressing in the coming years, due to the significant impact that user-friendliness has on patient adherence and, consequently on patient health.
Benefiting from Patients’ Insights
The quest for user-friendly dosage forms has the potential to be solved by engaging with patients and medical professionals, seeking their insight into how drug products can be more easily used.
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We are already seeing companies seeking out a better understanding of the patients using their drugs, their behaviors, and their preferences. For example, it has been a common practice to use taste panels for selection of suitable taste-masking for a long time.
However, we can expect companies to begin digging much deeper into the needs of patients as well as nurses and doctors. It is becoming increasingly important to understand how the product as a whole is perceived by the patient in a realistic dosing situation, and this perception may change depending on the patient group.
Focus groups with patients are becoming a widely used research tool, enabling companies to use qualitative as well quantitative methods to evaluate their preferences.
Other Trends Shaping the Dosage Future
In addition to changing manufacturing priorities and patient needs, there are other key drivers of rapid transformation in dosage forms that we can expect to affect the space in the coming years.
The rise of biopharmaceuticals will continue, leading to a corresponding growth in parenteral products. That being said, small molecules will continue to play an important role for a long time to come, due to their cost-effectiveness, which makes them highly attractive to healthcare providers with limited budgets.
The growth of precision medicine designed for smaller patient populations is likely to continue as well. This could have many implications for drug products and dosage forms, and the technology used to manufacture them.
For example, 3-D printing is a technology that may allow a very high degree of individual adaption of the medicine. However, a number of issues regarding quality assurance and cost may limit the use of 3-D printing in the next 10 years. Adapting conventional manufacturing technology to make it more flexible may be more useful to meet small-batch requirements.
Pellet technology and minitablets are examples of conventional yet flexible manufacturing technology that have the potential to allow the delivery of small-batch precision medicine. This is because it is easy to combine different pellets or minitablets to achieve combinations of different drugs in different doses and different release rates.
In addition, it is likely that patients will demand ever more control over their own medication. Packages and devices that communicate with smart phones or other devices and make it possible to track dosing and increase compliance may become more common. This will make it even more important for drug companies to keep user-friendliness and drug dosage innovation front of mind during the development stage.
Harnessing the Power of Outsourced Support
Adapting to an ever-changing pharma landscape is a challenge for drug companies of all shapes and sizes. In order to stay ahead of the curve, they need expert support and the capacity to deliver cutting-edge drugs in the right dosage forms to meet the needs of patients and medical professionals.
Advanced contract development and manufacturing organizations (CDMOs) are on hand to provide this expert insight and support.
Outsourcing dosage form development to these partners can play a key role in delivering ever more effective and user-friendly drugs that meet the market challenges of the future.
Outsourcing partners can provide customers with access to more technology and competence for dosage form development both locally and globally. As well as accessing technical capabilities and a global manufacturing network, pharma companies can also access years of development and formulation expertise that can help deliver vital dosage form innovation to meet changing market needs.
CDMOs also offer drug companies greater flexibility and by partnering with a CDMO that offers both development and commercial manufacturing services, customers can benefit from integrated support for their molecules from concept to market, reducing supply chain complexity, timelines and ensuring smoother progress of a drug to market.
Staying Ahead in A Fast-Changing Market
The pharmaceutical industry is changing fast. Innovation is becoming ever more important for pharmaceutical companies, as they strive to compete with rivals to deliver the most effective treatments to the market. The dosage form chosen for a drug has a key part to play here, due to its vital role in useability and user experience and well as therapeutic effect.
Whatever the future holds for the pharma industry, it is vital that companies have access to the expert support and capabilities they need to adapt to changing market needs.
By working with expert CDMO partners, they can ensure they have the guidance they need to meet new market challenges. In doing so, they can continue to thrive well into the future.
Author Biography
Torkel Gren is Senior Director, Technology Officer & Strategic Investments at Recipharm AB. He holds degrees in Pharmacy and Business Administration as well a PhD in Pharmaceutics (Uppsala University). He has worked in the pharmaceutical industry since 1988 and has held a number of scientist and manager positions in Europe and the US. He was lead formulator and coinventor of Detrol OD/Detrusitol SR. Gren is vice chairman of the board of the Swedish Pharmaceutical Society.