As pharmaceutical manufacturers attempt to survive and thrive in an increasingly intricate regulatory environment, the challenges of contract manufacturers have become more complex than ever. Today’s CMOs typically service a wide-ranging set of pharmaceutical companies whose products have equally wide compliance—and therefore, manufacturing—requirements. One size most certainly does not fit all.
In this environment, being a “perfect match” for a pharma manufacturer either means being lucky (in terms of your existing capabilities magically aligning with a potential customer’s) or agile in your ability to expand, alter, or reconfigure your manufacturing capabilities. And generally, luck is a far less reliable asset than versatility.
This flexibility takes willingness, creativity, and expertise, but more than anything it takes infrastructure investment. It may seem oxymoronic, then, that the ability to quickly adapt into new pharma manufacturing formats favors CMOs with tried and true traditional revenue streams.
Pharma Tech is finding that the tried-and-true dosage form of powder is helping to fast-track a fascinating future. There’s a reason for that.
The Power of Powder
When it comes to the development of new pharmaceuticals to replenish the drug pipeline, there always is a great deal of excitement about “specialty” items, such as injectable liquid biologics. While these may loom large and capture the spotlight, it’s important to acknowledge the fact that traditional powder-based oral solids continue to hold their own—and for good reason.
Oral dosage forms, such as tablets and capsules, are widely considered the most patient-acceptable dosage form. Patients and medical professionals appreciate them for their convenience and ease of handling. In addition, they’re extremely stable and offer high manufacturing throughputs that lead to favorable manufacturing economics.
Powders, however, offer some unique benefits from traditional solid dose. In cases where the sheer volume of necessary API is too great to be reduced to one or more tablets or capsules, powders offer the consumer the vehicle to mix the product with water to achieve the desired effect—often with greater compliance than their solid dosage brethren that can be difficult to swallow for many consumers (especially in the larger formats).
Additionally, powder formulations often are faster acting than solid dosage as the body can process the API more rapidly by ingestion or inhalation.
While there has been relative stability of the market for powder products over time, several new powder products are introduced to the market each year. Some of the most recent innovations have occurred in the Rx oral ingestible and inhalation arenas. On the oral OTC and supplement side, emphasis has been placed on incorporating new ingredients, flavors, and fragrances.
Today’s powders also are available in a variety of packaging configurations, giving consumers more say in how they absorb their medications. Currently, quite a bit of attention is being placed on the development of unit-dose packaging to meet consumer demand for easy-to-carry products. Stick packs serve the need of low unit-dose cost and portability, while sachets are both convenient and cost effective. Bottles, which have arguably been around the longest, provide customers with a bulk, multi-dose option.
Encapsulation and coated tablets are notable for their capacity for extended release and slower absorption, which is likely to ensure their continued dominance going forward. But in cases where swallowing a large tablet or capsule is not ideal for consumers, oral suspension powders become a great alternative that also brings the benefit of faster absorption. Again, it’s important to note that customers often are appreciative of the ability to exercise choice, and often seek out powders they can mix into their preferred beverage.
Powder has been a tried-and-true pharma winner that, glitz and glamor of new formats aside, will continue to power the industry as a baseline revenue generator. Pharma Tech Industries continues to place its primary focus on the powder-based products that have been the bedrock of its growth, even while expanding into more complex dosage forms and drug device combinations that incorporate powders, liquids, and gases.
In 2016, for example, Pharma Tech partnered with a major pharmaceutical company to launch a newly approved NDA inhalation product. The company is continuing to work on the project, and is in the midst of providing high-level tech transfer expertise coupled with dedicated facility space that includes product-specific manufacturing suites and equipment. It’s Pharma Tech’s belief that the plant-within-a-plant approach is where the contract manufacturing sector is heading.
Powder-based formulations are here to stay. Traditional, powder-based oral solids have been, and will remain, popular. They are economical in terms of production and consumption, easy to use, and highly stable and effective. And rather than inhibiting growth, powder’s reliability has instead fueled and funded innovation.
One growth area that should remain strong is the digestive health category, where probiotic supplements that aim to increase the number of good bacteria in our GI tract continue to grow in popularity. Drug and device combinations also are on the upswing, especially in the realm of inhalation.
While we are not seeing the high level of growth in topical powder products that we see in some of the niche ingestible and inhalation applications described above, Pharma Tech Industries benefits from relatively stable demand for these products which, in turn, can be used to fuel expansion into other new areas.
Additionally, many of the marketers of branded topical powders are global in nature. Strong relationships with these marketers allow for expansion into other niche capabilities like effervescent products and drug device combinations. We look forward to what the future holds for powders and for the company through continued reinvestment into the business.
About the Author
Tee Noland is the Chairman and Chief Executive Officer of Pharma Tech Industries.