In the dynamic landscape of pharmaceuticals, one innovation has consistently pushed the boundaries of drug delivery: the softgel capsule. Far from being just another dosage form, softgels have revolutionized the industry by transforming how medications are administered, and they continue to set a new standard in pharmaceutical technology.
The benefits of softgel formulations
Softgel capsules began to be manufactured on a commercial scale in the mid-20th century. By the 1960s and 1970s, softgel manufacturing technology had advanced sufficiently to allow for large-scale production, making softgel capsules a widely adopted choice for delivering various medicines and supplements orally.
Softgels are composed of a gelatinous outer shell, and with a liquid or semi-solid fill that contains the active pharmaceutical ingredient (API). This unique composition has been shown to help improve bioavailability for oral drugs that are poorly soluble or poorly permeable in the gastrointestinal (GI) tract. They also offer enhanced stability for active ingredients sensitive to air, moisture, or light. Consumers also tend to prefer the elegant appearance of softgels compared to tablets.
Pictured: Peter Surman, Chief Scientific Officer, Douglas CDMO
Enhanced bioavailability
A primary advantage of softgel capsules is their ability to increase the bioavailability of poorly soluble drugs. The inside fill of the capsules can be specifically formulated with solubilizers and emulsifiers to aid in dissolution and absorption of the API in the gastrointestinal (GI) tract.
By enhancing the absorption rate and overall bioavailability of the drug, softgels can minimize pill burden, ensuring the lowest effective dose is used to achieve its full therapeutic effect.
“As an industry, there are now systematic ways to develop self-emulsifying formulations to maximize the bioavailability of drugs, particularly those that are poorly soluble. It’s an area that our formulators are particularly skilled in. Optimizing oral bioavailability allows us to minimize the amount of drug needed to achieve its full therapeutic effect.”
Peter Surman, Chief Scientific Officer at Douglas CDMO
Versatility and protection
Stability and shelf-life are two critical factors when developing and manufacturing softgel products. Preserving the potency and efficacy of the API over time is important, not only for regulatory compliance, but also for safety reasons. A stable formulation prevents harmful degradation, ensuring the medication remains safe and effective until its expiration date. The added benefit is that this reliability enhances consumer confidence and trust in the product. Peter talks about how the properties of softgels enable their versatility and protection of the API:
“The proprietary intellectual property is often associated with the liquid fill inside the capsule. The properties of the fill are often critical for controlling and maximizing oral bioavailability. The shell casing needs to be durable, and often contains pigments and opacity agents to help protect the API from light and oxygen, enhancing stability and extending shelf-life. Additionally, an enteric coating can be used to protect the gelatin shell from the stomach’s acidic environment. This coating allows the capsule to reach the more neutral environment of the small intestine, where it can then rapidly release its contents.”
Patient compliance
Many patients prefer softgel capsules compared to the more traditional tablet or hard capsules, they are reported to be easier to swallow and more visually appealing for consumers. Peter explains:
“At the end of the day, people prefer taking oral medications over other routes of administration. Softgel capsules look and feel elegant, and the technology lends itself to poorly soluble drugs, making it possible to develop oral forms of medications that would otherwise be unsuitable for this route of administration.”
The future of softgels – looking at market trends
When considering the future of softgels, Peter identifies several key areas for continued innovation that promise to enhance their effectiveness and broaden their appeal.
“There will be ongoing advancements in optimizing drug bioavailability through nano formulations, which will be particularly useful in facilitating faster and more efficient absorption of the drug into the bloodstream.
We’ll also see more vegetable-based gelatin alternatives transitioning into the pharmaceutical space as the technology improves.”
Douglas CDMO – an expert partner in softgel technology
Douglas CDMO is a New Zealand success story. With a solid reputation in the softgel market and an approximate 30% share of the United States retinoid sector, Douglas is also distinguished as the first company in the world to produce a generic isotretinoin softgel for the treatment of severe acne. Douglas prides itself on the continuous supply of this product to customers in the US, EU, and ROW, some for over 20 years. Peter emphasizes the company’s expertise in softgels as its hallmark attribute, known for high manufacturing standards and quality outputs.
The complex nature of softgel manufacturing, involving specialized equipment and proprietary formulations, presents significant barriers to their generic production. This complexity ensures the preservation of product quality and efficacy, safeguarding investments. Douglas CDMO’s success story includes both generic and novel softgel developments.
This dual proficiency in excelling at both generic and novel softgel development and supply positions Douglas CDMO as a dependable and adaptable partner within the pharmaceutical industry.