Capsule formulation: future trends

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In this Q&A, Recipharm’s Torkel Gren discusses developments in capsule formulation, including the shift away from gelatine and the potential for growth in the inhalation capsule market. Rdp Hpmc

Gelatine also poses potential long-term performance challenges”

Several major trends have emerged in recent years in the capsule space. First, we are seeing growing demand for new materials to replace the traditional gelatine capsule shell. One of the reasons for this is the growing importance of offering an alternative vegan capsule for patients who, for dietary reasons, do not want to consume animal products. Gelatine also poses potential long-term performance challenges that can impact on the shelf life of a product – for instance, it can become insoluble when stored in certain storage conditions, resulting in a capsule that will not release any drug. The next generation of shell materials replacing gelatine, such as hydroxypropyl methylcellulose (HPMC), are not only vegan, but have a lower moisture content, offering greater performance consistency and maximising product shelf life.

Another trend we are seeing is the development of more sophisticated capsules to serve as research tools in pharmaceutical development. For example, there have been capsules created that allow for monitoring of external conditions, such as pH, and that enable external control over drug release. These newly developed tools can be used in clinical research, such as in drug absorption studies, and can contribute to faster and more efficient development of oral pharmaceutical products.

Finally, in terms of the manufacturing process, capsule filling is gradually becoming more efficient, which, in combination with new capsule materials such as HPMC, is making capsules an even more attractive oral dosage form for many drug products.

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Capsules also offer the easiest method to achieve fixed-dose combinations of incompatible drug substances”

Capsules offer a great solution to the challenge of creating sophisticated modified-release products. By mixing different coated pellets or minitablets, multiple intricate and precise drug release patterns can be achieved.

Compared with other oral solid dosage forms, capsules also offer the easiest method to achieve fixed-dose combinations of incompatible drug substances. By mixing coated granules, pellets or minitablets within a capsule, incompatible drug substances can be incorporated into a single dose without stability issues. This has benefits for patients that are prescribed complex treatments requiring the administration of multiple active pharmaceutical ingredients (APIs) as it is possible to reduce the number of daily doses to a single multi‑API capsule, enhancing convenience and patient adherence in turn.

Capsules offer benefits when rapidly developing a product for clinical trials”

Further than this, capsules offer benefits when rapidly developing a product for clinical trials. Capsules can avoid the issue of ensuring sufficient compactability for a coherent tablet to form and make it more straightforward to vary the dose. Additionally, a placebo is simple to create by filling identical capsules with an excipient, such as lactose, starch or cellulose.

Capsules are in many cases the best way to create an oral fixed-dose combination, as it is easy to separate the different drugs to avoid incompatibilities. As a result, there is growing interest in capsules for orally administered drugs.

There are two different drivers for fixed-dose combinations. First, as mentioned above, by reducing the number of pills that a patient is required to take, it is possible to increase convenience for the patient and reduce the risk that they may forget to take one of their daily doses. This is one way to improve patient adherence to a prescription and ensure efficacy of the treatment.

Second, there is considerable interest across the industry in repurposing existing drugs for new indications and often this means that two or more known active ingredients are combined in one treatment. As mentioned above, capsules are ideal for this, as they allow two drug substances to be easily combined in a single dose while minimising concerns about compatibility.

Capsule formulation development: OSD contract manufacturing market valued at $54.7 billion by 2030…

The main limitation of capsules is their size, and in higher doses of drugs, the capsules needed are relatively large. The issue here for patients is both physiological and psychological. It is true that larger capsules can be more difficult to swallow than smaller capsules.

However, as capsules are generally smooth, with an elongated shape, even larger capsule sizes are relatively easy to swallow compared with some traditional oral solid dosage forms. Nevertheless, to certain patients, the larger capsules required for some multi-API drug products or those with complex controlled release profiles can be perceived as difficult to swallow. This can create challenges in terms of patient compliance. To combat this, work is being done by contract drug development partners to advance formulation development with the aim of further reducing the size of capsules for complex drug products to help optimise patient comfort in future.

Another drawback is that traditionally capsules have been slightly more expensive to produce than tablets, which is due to the cost of the capsule shell and a slightly slower manufacturing process than tablets. However, it should be noted that several steps in tablet manufacturing, such as granulation and coating, can be quite time-consuming and therefore, in a growing number of cases, capsules are becoming a more cost-efficient solution than tablets.

One further issue is that capsules tend to be more sensitive to high temperature and higher moisture when compared with tablets. However, this problem is being addressed with the advent of new capsule materials that are less susceptible to such challenges, helping to maximise shelf life.

We will see a continued process of shifting from gelatine to HPMC and other new capsule materials. This is due to the increasing adoption of a vegetarian diet, as well as greater uptake in markets with hot and humid climates. As the shelf-life limits of capsules are being overcome with these new shell materials, we will see even broader use of capsules among all oral drugs. New types of drugs, such as oral vaccines, will also be formulated as capsules.

Formulation development outsourcing market to be worth over $60bn by 2030…

There may also be growth in capsules for inhalation. We expect a steep increase in asthma and chronic obstructive pulmonary disease in low- and middle-income countries. This will lead to demand for cost-efficient inhalation medicine and inhalers. Dry powder inhalers using drug substance in capsules are relatively cost-efficient devices and the capsule filling is a simple process. We believe that this may offer one solution to provide affordable inhalation therapy. Conversely, there will be challenges for capsules, such as a strong trend toward injectable medicine, as more and more new drugs are biologics and usually require injection. We will also see progress in alternative ways for drug products to be manufactured, such as 3D printing. Yet, due to the patient convenience of capsules, combined with their unique controlled‑release benefits, I am convinced that there will be a strong need for capsules in the coming decades.

Torkel Gren, PhD is Senior Director, Technology Officer & Strategic Investments at Recipharm. Torkel Gren has worked in the pharmaceutical sector since the late 1980s. He holds degrees in Pharmacy and Business Administration as well a PhD in Pharmaceutics (Uppsala University). Torkel is chairman of the board of the Swedish Pharmaceutical Society (Apotekarsocieteten).

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