Softgel Capsules Explained: The Ultimate FAQ Guide (Part I)
Softgel capsules have become a common sight in medicine cabinets and supplement shelves worldwide since their invention in the 1930s. This unique dosage form offers a combination of ease of use, effectiveness, and consumer appeal, leading to their widespread adoption across various health and wellness products.
Compiled from questions that our team has gotten over the years, this article addresses some of the most frequently asked questions about softgel capsules from a consumer perspective, providing insights into their composition, benefits, and usage. We hope this resource will enhance your understanding of softgel capsules, whether you're a pharmaceutical professional, a student, or simply curious about this popular dosage form.
1. What are softgels?
It may appear to be a simple question, but let's address it directly: what precisely are softgel capsules? Softgel capsules, also known as soft gelatin capsules, are a unique oral dosage form in the pharmaceutical and nutraceutical industries. Simply defined, softgel capsules are a solid oral dosage form containing a liquid or semi-solid capsule fill with the active ingredient. The fill is encapsulated in a hermetically sealed capsule shell.
They consist of a gelatin-based outer shell that encapsulates a liquid or semi-solid fill. This design allows for the delivery of a wide range of active ingredients, from medicines to vitamins and dietary supplements, in an easy-to-swallow format.
Unlike hard shell capsules (also called two-piece capsules), softgels cannot be simply opened without destroying them, which provides additional protection for the encapsulated material and can help prevent tampering. The versatility and unique properties of softgels make them a popular choice for both prescription drugs and over-the-counter products.
Interested to know more about what softgel capsules are and their history? Read our article on softgels:
2. Do softgel capsules act faster than other oral dosage forms?
Softgels can often provide a faster onset of action due to the rapid rupture of the gelatin shell and pre-solubilized active ingredients in the fill. This quick-acting property is evident in many over-the-counter analgesics, such as those containing ibuprofen or diclofenac. Some liquid formulations in softgel capsules may also enhance absorption or reduce first-pass metabolism in the liver, further enhancing the drug's effects.
However, softgel capsules aren't always designed for rapid release. Some formulations offer extended or delayed-release properties. This versatility is particularly beneficial for lipophilic drugs with poor water solubility, as softgels can improve their bioavailability regardless of the desired release profile.
3. Are softgels better than tablets or hard capsules?
The choice between softgels, tablets, and hard capsules is not a matter of one being universally "better" than the others. Rather, it's a decision based on a complex interplay of factors related to the drug, the intended use, and manufacturing processes. Let's explore these factors in more detail:
Nature of the active ingredient: Softgels shine when it comes to delivering poorly water-soluble drugs and liquid or lipid-based formulations. They're also an excellent choice for substances sensitive to oxidation.
Desired release profile: Different dosage forms can be designed for immediate, delayed, or extended-release, depending on the therapeutic goals.
Target patient population: Factors like age, swallowing ability, and medication adherence can influence the choice of dosage form.
Manufacturing considerations: For instance, highly potent drugs might require special handling during production, which could favor one form over another.
While softgels have clear advantages in certain scenarios, tablets or hard capsules might be the better option in others. These traditional solid oral dosage forms often benefit from more extensive development and manufacturing expertise in the industry. They can also be more cost-effective to produce, which can be a significant factor in drug development and commercialization decisions.
Ultimately, each dosage form has its place in pharmaceutical development. The key is to conduct a comprehensive assessment of all relevant factors to determine the best fit for each specific drug and its intended use. This holistic approach ensures that the chosen form optimally balances efficacy, safety, patient needs, and manufacturing feasibility.
Interested in knowing more about the difference between hard tablets and softgel capsules? Read our article about that topic here:
4. What are softgel capsules made of, and are they safe?
Softgel capsules shells are primarily composed of gelatin derived from animal collagen, typically from bovine or porcine sources. This gelatin forms the capsule's structure. Water is used during processing and remains a key component in the formulation. Plasticizers such as glycerin or sorbitol are added to improve flexibility and stability during storage. Some formulations may include optional additives like colorants and ink for product identification or coatings for modification of the release characteristics.
Generally, gelatin capsules are considered safe for consumption and have been widely used in the pharmaceutical and supplement industries for over a century. However, they may not be suitable for everyone. Individuals with specific dietary restrictions, such as vegetarians or vegans should seek alternative dosage forms or vegetarian capsule options.
Interested in knowing more about shell development? Read our e-book about that topic here:
5. How long do gelatin capsules take to dissolve?
The dissolution time of gelatin capsules is defined by design, depending on whether the capsule needs immediate-release or modified-release properties.
For immediate-release capsules, pharmacopeial requirements stipulate disintegration within 30 minutes in water. However, a fresh capsule typically disintegrates much faster, often within 10 minutes.
Gastro-resistant capsules should remain insoluble at low pH values (mimicking the stomach environment) for at least 1-2 hours, and then dissolve in water or intestinal fluid within 1 hour.
Note: While these are the pharmacopeial standards, the behavior in vivo (in the body) may not necessarily match exactly. Dissolution time can vary depending on factors such as:
Capsule formulation
Fill material
Physiological conditions (e.g., pH, temperature)
Interested in knowing more about quality control? Read our e-book about that topic here:
6. How are softgel capsules manufactured?
The softgel manufacturing process involves several key steps:
Preparation of the gelatin-based shell mass
Preparation of the fill material
Encapsulation
Drying
Inspection
Quality control and packaging
Specialized equipment, such as rotary die encapsulation machines, is used to produce softgel capsules at a commercial scale.
Interested in knowing more about the softgel capsule manufacturing process? Read our article about how they’re made:
7. Is it easier to swallow softgels or tablets?
Softgel capsules are generally considered easier to swallow than tablets. This is due to their smooth, elastic outer shell which allows them to slide down the throat more easily. The gelatin shell also becomes slippery when wet, further facilitating swallowing, and the smooth, oval shape of softgel capsules facilitates easier swallowing compared to tablets or hard capsules, which can improve patient compliance. However, it’s worth noting that individual experiences may vary, and some patients may find tablets or other dosage forms preferable.
Interested in knowing more about the difference between softgel capsules and tablets? Read our article about the differences
8. Are there alternatives to gelatin for softgel capsules?
Over the years, the pharmaceutical industry has developed several vegan alternatives to gelatin for softgel capsules, responding to growing consumer demand for plant-based options. However, gelatin's unique properties make it challenging to find a substance or mixture with a similar technological profile that can be processed on the same equipment.
These alternatives primarily include plant-based polymers such as modified starches and carrageenans, which can mimic gelatin's properties in forming flexible, dissolvable capsule shells.
These plant-based alternatives are gaining popularity, especially in the dietary supplement market and for products targeting specific consumer segments.
However, each alternative presents its own challenges in terms of manufacturing processes and stability. These issues continue to be areas of ongoing research and development as the industry strives to match gelatin's performance while meeting the demand for vegan options.
Interested in knowing more about shell development? Read our e-book about that topic here:
Want more advice about which delivery form is right for you?
Our team offers the following:
+ Decades of experience in solid dosage form development
+ Support in the concept phase to establish the right dosage form for your product
+ Preparation of formulation concepts and target product profiles
