Douglas is an expanding pharmaceutical company and global contract development and manufacturing organization (CDMO) with world-class expertise in developing and manufacturing high-potency softgel and liquid formulations. With its headquarters in New Zealand, Douglas provides a strategic alliance for its Northern Hemisphere partners, facilitating a nearly 24-hour operational cycle, an efficient pathway to human clinical trials, and competitive advantages in cost, speed, and quality.
Douglas is a New Zealand success story and is a leading supplier of pharmaceutical softgels to the U.S. and European markets. In this Q&A, Peter Surman, Chief Scientific Officer of Douglas, discusses the case for softgel formulations and the strategic benefit of partnering with a CDMO with demonstrable expertise in the area.
Contract Pharma: What are the current market trends driving the demand for pharmaceutical softgels?
Peter Surman: There are several market trends driving the current demand for pharmaceutical softgels. Firstly, the elegance of softgels makes them a preferred choice for over-the-counter (OTC) products. They have a visual and tactile appeal, and the ease of swallowing these dosage forms appeals to customers, enhancing the overall user experience. Secondly, softgels are optimized for the delivery of therapeutic candidates; they help increase the bioavailability of poorly soluble or poorly permeable small molecules and can enhance the chemical stability of the active ingredients, which are otherwise unstable when exposed to air or light. By improving bioavailability, softgels ensure that the active ingredients are more effectively absorbed by the body, while product stability is vital for maintaining the efficacy and shelf life of the drug.
CP: What distinguishes Douglas as a leader in the development and manufacturing of pharmaceutical softgels?
Peter: There are several key attributes we have here at Douglas. Firstly, we have a long-standing history in the field, having developed softgel formulations since the 1990’s. This extensive experience has allowed the company to become adept at handling the complexities of these dosage forms. One of our most notable achievements is the development of the first generics of isotretinoin and alitretinoin softgels, both of which presented significant challenges in their development.
We also have a broad portfolio of other pharmaceutical softgels, which demonstrates our versatility and expertise in the field. We work with both generic and novel small molecules and are very comfortable in both spaces. Beyond oral softgels, we have formulated a novel 505(b)(2) softgel product as a pessary that has significantly improved topical drug delivery to treat high grade cervical dysplasia. We supply a significant market share for most of our softgel products. The manufacturing of softgels can be difficult, requiring skilled operators and technical experts to ensure consistent product quality. Our competitors often struggle with technical challenges causing them to drop in and out of the market.
With headquarters in Auckland, Douglas is a New Zealand success story and is a leading supplier of pharmaceutical softgels to the U.S. and European markets
CP: Can you explain the key benefits of pharmaceutical softgels compared to other oral dosage forms, such as tablets and capsules?
Peter: Factors such as improved oral bioavailability of the drug, improved stability of the drug, and greater market differentiation all play a part in why softgels are a highly advantageous dosage form. The oleaginous fill of many softgels aid permeation of the active ingredient through the epithelium of the gut to improve systemic blood levels to reduce pill burden. This is especially relevant for actives that are poorly soluble in water. The body can absorb and utilize the medication more efficiently.
Softgels need to be manufactured using precise filling techniques to ensure that each capsule contains an exact amount of active ingredient. This uniformity in dosage is important to maintain consistency of therapeutic effects. For softgels where the active substance is suspended in the capsule fill, care must be taken to prevent solids from settling during the filling process.
For active ingredients that are sensitive to air, moisture or light, softgels provide improved stability. The encapsulation process and the protective coating shield the compounds from degradation, ensuring the medication remains effective throughout its shelf life. The visual and tactile properties of oral medicines is important to patients, both from a functional and aesthetic perspective. The shiny, smooth appearance of capsules and ease of swallowing are qualities that can influence purchasing decisions.
The softgel manufacturing process is complex and technically demanding, requiring a high level of expertise. Achieving and maintaining the quality and consistency of softgel products provides a competitive edge in the marketplace. This complexity allows for greater market exclusivity, as it is difficult for competitors to replicate production techniques and achieve the same level of quality or copy your product.
CP: What specific technologies and processes does Douglas employ to ensure the high quality and consistency of their soft gels?
Peter: At Douglas, we have state-of-the-art facilities and specialized equipment that is critical in maintaining precise control over the formulation and ensuring dosage uniformity and quality across batches. We have invested in technologies such as wet media milling capabilities, enabling us to produce proprietary particle size distributions to tune oral bioavailability and ensure fill precision from the first to the last capsule produced in a batch. Our formulators are skilled in the development of self-emulsifying delivery systems to enhance the bioavailability of poorly soluble drugs, and to facilitate their absorption in the gastrointestinal tract. Optimizing bioavailability allows us to achieve the minimum effective dose for the product, ensuring the lowest amount of the drug is used to achieve its full therapeutic effect.
The environmental controls in the room are important, and our manufacturing environment is meticulously controlled. Maintaining ideal temperature and humidity specifications in manufacturing rooms is as critical for softgel processing as the machinery itself. Stable environmental conditions contribute to consistent product quality.
CP: How do softgels enhance the bioavailability of active pharmaceutical ingredients (APIs), and why is this important for patient outcomes?
Peter: Softgels enhance the bioavailability of APIs through their unique formulation, particularly the use of an oil-based fill. The oil fill acts as an excellent carrier, significantly improving the solubility of poorly soluble drugs. When these compounds are dissolved or suspended in the oil matrix, they are more readily absorbed in the gastrointestinal tract, making the drug systemically bioavailable. Enhancing drug bioavailability to reduce the minimum effective dose of the product can also help reduce the risk of side effects for the patient.
CP: What are the main challenges in the formulation and production of softgels, and how does Douglas overcome them?
Peter: There is a certain amount of science and a certain amount of art involved in the formulation and manufacturing process. Firstly, you need to have a good understanding of the materials you are using to make the drug. Sourcing good-quality ingredients is critical to development success, and often here at Douglas we end up developing tests that are specific to the ingredient and beyond the requirements of pharmacopeia.
We follow the tightest specifications for capsule dose to ensure accurate filling and dosage uniformity across batches. Having good control over the filling and encapsulation process is important, and it can all fall apart if you don’t have experienced operators.
Issues can also arise in the drying process, so we maintain a state-of-the-art heating, ventilation, and air conditioning (HVAC) system for our softgel lines to control temperature and humidity, preventing capsules from absorbing moisture from the environment during drying, which could cause them to burst.
Attention to detail is critical throughout the manufacturing process, as you want to end up with a stable product with a decent shelf life.
As Chief Scientific Officer, Dr. Peter Surman brings over two decades of strategic leadership in the pharmaceutical industry, with a focus on guiding the development of both generic and novel pharmaceuticals from inception to market. His expertise spans new product development, portfolio management, change management, performance management, project oversight, formulation strategies, API, and process optimization. Peter has successfully steered the end-to-end development and commercialization of more than 20 pharmaceutical products. His visionary approach and commitment to innovation positions him as a leading scientific figure in New Zealand.
CP: Why should pharmaceutical companies consider softgels for their next oral dosage form, and how can partnering with Douglas CDMO facilitate this transition?
Peter: Softgels provide an innovative way to develop a proprietary formulation for your drug, particularly if the candidate has poor oral bioavailability, is chemically unstable, or highly potent. These are areas where softgels offer compelling and effective solutions. At Douglas CDMO, we pride ourselves on our commitment to quality and customer satisfaction. By partnering with us, our clients benefit from our extensive expertise and dedicated support throughout the development and manufacturing process. We understand the importance of your business and aim to deliver innovative solutions that meet your specific needs, ensuring a successful product launch and sustained market presence.
CP: When did Douglas move into the CDMO space, and what inspired the company to expand into CDMO services? How does this align with the company’s long-term strategic goals?
Peter: We’ve been offering CDMO services on an ad hoc basis for many years. However, the company recently made a significant strategic move to formalize and expand these services. We’ve invested significantly in opening a new R&D precinct for all contract development and manufacturing projects, and we have shifted our business model towards client projects, as a cornerstone of our business.
CP: What specific capabilities and services does Douglas CDMO offer that differentiate it from other CDMO providers in the industry?
Peter: Quality is ingrained in every aspect of our operations, with continuous improvement initiatives optimizing efficiency and ensuring robust analytical capabilities.
We excel in state-of-the-art softgel manufacturing, but we also specialize in multi-particulate solid dosage forms, offering expertise in modified release products tailored for targeted delivery in the gastrointestinal tract. This precision helps mitigate undesirable side effects, enhancing therapeutic outcomes.
Our comprehensive services are provided by dedicated staff with long tenure and a deep understanding of pharmaceutical challenges. Our high staff retention rate ensures clients benefit from a consistent project team and a reliable point of contact. This guarantees high-quality solutions, supported by the personal pride of our formulators and analytical chemists who are driven problem solvers. Clients enjoy strong, valued relationships and streamlined communication.
Douglas CDMO’s location in New Zealand also provides strategic advantages for United States and European partners. The time zone difference enables global partners to hand over tasks or issues at the close of their workday, facilitating a nearly 24-hour operational cycle. This arrangement can significantly accelerate project timelines and potentially reduce time to market.
Learn more at www.douglascdmo.com
