The Power of Powder in Pharmaceutical Manufacturing
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 CDMOs 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. Though it may seem oxymoronic, then, the ability to quickly adapt into new pharma manufacturing formats favors CDMOs with tried and true traditional revenue streams.
At PTI, we’re finding that the tried and true dosage form of powder is helping to fast track a fascinating future. There’s a reason for that.
When it comes to the development of new pharmaceuticals to replenish the drug pipeline, there is always 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 API necessary 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 time with greater compliance than their solid dosage brethren which can be difficult to swallow for many consumers (especially in the larger formats). Additionally, powder formulations are often 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 assure their continued dominance going forward. But in cases when swallowing a large tablet or capsule is not ideal for consumers, oral suspension powders become a great alternative that also bring the benefit of faster absorption. Again, it’s important to note that customers are often appreciative of the ability to exercise choice, and often seek out powders they can mix into their preferred beverage.
The point is that powder has been a tried-and-true pharma winner that, the glitz and glamor of new formats aside, will continue to power the industry as a baseline revenue generator. My company, Pharma Tech Industries of Athens, GA, continues to place our primary focus on the powder-based products that have been the bedrock of our growth, even while expanding into more complex dosage forms and drug device combinations that incorporate powders, liquids, and gases.
Several years ago, for example, we partnered with a major pharmaceutical company to launch a newly approved NDA inhalation product. We’re continuing work on this project and are in the midst of providing high-level tech transfer expertise coupled with dedicated facility space that includes product-specific manufacturing suites and equipment. We believe this plant-within-a-plant approach is where the contract manufacturing sector is heading.
The Future of Powder Based Formulations
Powder-based formulations are here to stay. Traditional, powder-based oral solids have been, and will remain popular, as 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 & device combinations are also 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, PTI benefits from relatively stable demand for these products which can in turn be used to fuel expansion into other new areas. Additionally, many of the marketers of branded topical powders are global pharmaceutical in nature. Our strong relationships with these marketers, which is built on the trust and reliability we have demonstrated for these products, has allowed us to expand into other niche capabilities like effervescent products and drug device combinations. We look forward to what the future holds for powders and PTI as we continue to reinvest into the business.
Pharma Tech Industries is a trusted solutions provider for powder-based products and custom services, offering development to high-volume commercial scale production services across a wide variety of delivery formats and systems.