Softgel formulations can often address the stability, shelf-life and bioavailability challenges encountered in the development of oral medicines but require specialist expertise to deliver consistent production quality. Partnering with a Contract Development and Manufacturing Organization (CDMO) that has world-class expertise in softgel technology can ensure products meet the highest standards of quality.
Softgel formulations are an oral dosage form characterized by a gelatin-based outer shell encapsulating liquid or semi-solid contents. This is a versatile dosage form with specific advantages over other oral dosage forms. Peter Surman, Chief Scientific Officer, at Douglas CDMO, explains why companies ought to consider a softgel dosage form:
“The active pharmaceutical ingredient (API), is often unstable, has low solubility and can often be quite toxic. The properties of softgel products, including their oil-based nature to improve drug absorption and sealed environment to reduce dust and operator exposure, help to overcome these issues.”
There are three main benefits of softgel products:
1. Softgel dosage forms can increase drug bioavailability compared with capsules or tablets.
In a softgel capsule, the active drug is dissolved or suspended in an oil-based liquid fill often in the presence of emulsifiers to create a micro emulsion once taken This can enhance the oral bioavailability of poorly soluble drug substances compared to the dried powder form of capsules or compressed tablets. Henry Jackson, Group General Manager of Technical Services at Douglas CDMO, raises an additional advantage of softgel products: the same biological activity can often be achieved with less active product when compared to capsules or tablets, potentially driving cost efficiencies.
2. Softgel dosage forms help preserve the stability and efficacy of the drug substance and are often easier to swallow than tablets and hard gelatin capsules.
A distinctive feature of softgel products is their soft, gelatin-based shell. This not only provides a sealed environment, protecting unstable ingredients from air and light, but creates a soft, flexible, and smooth texture, making them easier to swallow when compared to other solid dosage forms. The oil-based fill protects that drug substance from oxidation, maximizing shelf-life.
Customer preference is also an important consideration for companies when choosing between softgel and other solid dosage forms. Peter notes, “I’ve noticed with interest that consumers in the over-the-counter market prefer softgel products, and when faced with a choice of their medication in tablet or softgel form, will often choose the softgels. Even if there is a price point difference, people will gravitate to the elegance and ease of taking the softgel product”.
3. Softgel products minimize the exposure of manufacturing staff to toxic drug substances.
The toxicity of a drug should be considered carefully when deciding on a dosage form. Henry emphasizes the importance of a safe working environment, noting, “Softgel manufacturing offers a safer environment for employees, especially when compared to the dust potential associated with tablet production.”
Douglas CDMO: delivering world-class expertise in softgel technology.
Considered a key player in the US retinoid drug market, New Zealand-based Douglas CDMO is fast becoming synonymous with excellence in softgel formulations. The company leverages its advanced technology and research expertise to develop a diverse range of softgel products that meet high standards of safety and efficacy. As a result, Isotretinoin, a softgel formulation developed by Douglas CDMO, has established a significant market share in the US.
“There aren’t many pharmaceutical companies that can continue delivering quality softgel capsules – many companies drop out of the market quickly due to quality issues; however, we’ve been able to maintain market share in the US due to the quality of our products and institutional expertise of our operators.”
Peter Surman, Chief Scientific Officer, Douglas CDMO
Peter attributes the technical expertise, the technological capabilities, and the stringent quality control processes found at Douglas CDMO as central to the company’s success.
Quality is paramount in the production of softgel formulations and an important consideration for companies looking to engage a CDMO partner. “The level of vigilance the team has in all areas of production – from development to manufacturing to market quality surveillance, both for novel and generic drug production – is a big advantage for clients looking for a successful CDMO partnership,” Henry states. He further elaborates that the compliance to quality control protocols, such as cleaning, cross-contamination validation and safety processes for handling toxic compounds makes Douglas a competitive CDMO partner.
As a CDMO partner, Douglas can work with companies in the early stages of drug development or later in a product life cycle. For both novel and generic compounds, Peter urges companies to get in touch in the early stage of formulation development to ensure that they take the most bioavailable and stable formulation into clinical studies. “We are very familiar with the early-stage aspects of product development. We can support our clients with first in human trials through to registrational studies and help guide them in the supply of commercial products,” he concludes.