Solid Dosage Formats Remain the Dominant Pharma Trend

Solid Dosage Formats Remain the Dominant Pharma Trend

Oral solid dosage forms (OSDFs), notably capsules and tablets, continue to be the most popular drug form used worldwide. Here are some common questions and insights from Deepak Thassu, VP of LGM Pharma’s R&D and Regulatory Division, about OSDF use and manufacturing.

1. Why do OSDFs dominate the global pharmaceutical market?

Solid dosage forms may not be a sexy new technology, but they are a proven one that’s critically important to the pharmaceutical industry – especially when you consider generic formulations. Cost is always a key factor, especially in today’s hyper-competitive market. OSDFs remain one of the most cost-effective delivery methods. They also tend to be easy to manufacture, easy to take, and are more likely to ensure patient compliance than powders, liquids, sprays or other non-solid medications.

2. Just how popular are OSDFs compared to other types of drugs?Just how popular are OSDFs compared to other types of drugs?

There are so many different drugs and drug manufacturers that it’s difficult to track the data, but I can tell you anecdotally that the vast majority of the new product requests we get are for OSDFs. Historically I’d say about 65% of our client requests have been for tablets, though more recently that number has risen closer to 75%. Capsules account for just about everything else. LGM Pharma (through our acquisition of Nexgen) also manufactures powder blends, suppositories, semi-solid and liquid drugs, though fewer customers tend to request them.

3. Most people are familiar with tablets and capsules. Do OSDFs come in other forms?

Tablets and capsules are the primary forms, but there are variations of each type. Some medications are designed for immediate release, which means the entire dose is released at once, as opposed to extended-release drugs that deliver the dose gradually over time. You can find many examples of these two approaches in both tablet and capsule forms.

There also is a range of specialized variations such as orally disintegrating tablets, or ODTs. These are similar to traditional tablets but are designed to dissolve on the tongue rather than to be chewed or swallowed whole.

pharma companies like beadlets because they deliver a range of color options – making it easy to produce a very distinctive-looking product. Beadlets also offer advantages for patients, as well. They can make it easier for the body to absorb medications, and provide a convenient way to combine ingredients that you don’t want to interact with one another before the patient swallows the capsule.On the capsule side, we produce a lot of what are called beadlets – the tiny orbs often seen packed into a capsule. Many pharma companies like beadlets because they deliver a range of color options – making it easy to produce a very distinctive-looking product. Beadlets also offer advantages for patients, as well. They can make it easier for the body to absorb medications, and provide a convenient way to combine ingredients that you don’t want to interact with one another before the patient swallows the capsule.

Those are just a few of the most common examples. We have development and manufacturing capabilities for many forms, such as timed and modified release tablets, complex bead and granule layering and coating options, high-shear granulation and coating, specialized blending, and a practically infinite range of sizes and shapes. There are many solid dose options to choose from when designing your drug delivery system.

4. How do drugmakers decide whether to use tablets or capsules?

That’s an excellent question — and there are some long-standing debates about it which aren’t likely to be resolved any time soon!

In some cases, one format or the other will have a clear advantage. For example, if you need to mix two incompatible substances together (as we mentioned above), a beadlet capsule is the obvious choice. On the other hand, if stability is a critical concern, you’ll probably get better results from a tablet.

In many cases, drug manufacturers can choose from either of these popular solid dosage forms – and the choice will come down to a number of different factors.

Historically, for example, tablets have been preferred in the U.S. while capsules have been more popular in Europe. One key consideration is simply regional preference. Historically, for example, tablets have been preferred in the U.S. while capsules have been more popular in Europe.

Tablets are often smaller, it’s easier to control their quality, and their raw materials tend to be cheaper. On the other hand, capsules are less expensive to manufacture, can be produced with fewer ingredients, don’t have an unpleasant taste, and are found by many people to be easier to swallow. Which way you go is often a balancing act between a number of factors, from the size of tablet or capsule you need to deliver a dose, to absorption, the need for additives, taste, and other considerations.

5. What does the future hold for OSDFs? Are they likely to remain the leading format for pharmaceuticals?

At present, we’re seeing a bit of a slowdown because of the COVID-19 pandemic – but that’s impacting most if not all other drug formats as well. Going forward we expect OSDFs to maintain their market dominance for years to come.

A recent report on this market concluded that OSDFs will maintain their lead at least through 2027, and I expect it will continue much longer. Tablet sales are expected to make up the largest percentage, followed by capsules. There are some regional ups and downs — Japan is slowing a bit while Latin America is on track to become the fastest-growing region in the market. And we’re still seeing plenty of OSDF patent applications across the spectrum of pharma development.

6. What trends and challenges do you see in today’s OSDF market?

Obviously, the global health crisis continues to strain the entire industry, but for OSDFs in particular two major shifts are significant: smaller batches and higher-potency drugs. These are partly driven by the expiration of some of the most profitable patents, partly by technological innovation, and partly by demographics. For instance, many people are living longer, and the elderly typically need more potent and specialized drugs. New oncology treatments, in particular, are driving a lot of this. Since 2012, we are also seeing much stronger growth in the demand for pediatric products thanks to regulatory changes and FDA incentives.

Ask any pharma manufacturer what kind of challenges these changes are creating and you’ll hear several common themes. Solubility — how easy it is for a drug to dissolve — is easily the biggest challenge the industry is grappling with right now, because many next-generation drugs have much lower solubility levels. Higher-potency drugs also tend to be more complex, with correspondingly complicated processing needs. There’s more demand for things like controlled-release formulations or manufacturing technologies such as spray drying.

On the whole though, these challenges aren’t holding the industry back. The vast majority of pharma venture capital still is being invested in new OSDF products, and we expect the market to continue offering significant opportunities for years to come.

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