Pharmaceutical companies use capsules to store and deliver medications. There are two types generally: the soft type and the hard type. They differ in terms of their composition and the purpose they serve.
What Are Soft Gelatin Capsules?
The soft gelatin capsules are made up of a strong and thick gelatin shell. You can find them transparent or partly transparent, which makes the substance in them very visible. Furthermore, these capsules are very useful in the storage of oils, suspensions, as well as other liquids.
An example of softgel capsule is cod liver oil. These single-piece capsules are ideal for medications that are very sensitive to moisture. Some medications need to remain in liquid form to improve their absorption rate. It is therefore important you encapsulate such drugs in soft gelatin capsules to maintain their function.
What Are Hard Gelatin Capsules?
This hard type is divided into two, which is the body and the cap. It is for this reason that they are at times called two piece capsules. The body serves as a storage space for the medication while the cap provides it with a covering.
These hard capsules play an important role when storing your powdery medications. It also helps for granular drugs. They are usually made up of water, gelatin, as well as plasticizers. With water, the gelatin can stay flexible and make sure that the content of the moisture stays within a specific range (not higher than 16%).
The addition of plasticizers ensures that the gelatin capsule is less brittle. Hard Gelatin capsules break down easily once you consume them, ensuring proper absorption.
Hard vs Soft Gelatin Capsules: Explaining the Differences
Manufacturing Process
Hard Gelatin Capsule
Hard Gelatin capsules have two main parts which include the body and cap. The manufacturing process requires you to immerse stainless steel mold pins in a pure gelatin solution. After which, you rotate these pins and strip them off to produce hollow capsule shells. This process also requires you to trim the body and cap of the capsule to the required length, after which you join them.
You need specialized filling machines to fill the capsules with medications in form of powder, granules, or pellets. Hard Gelatin capsules help you to maintain perfect dosage combinations for medications.
Soft Gelatin Capsule
Soft gelatin capsules are just a single piece capsule. Therefore, it requires just one single step to fill these capsules. In the softgel manufacturing process, you need to heat a gelatin sheet to form a tube and fill the substances in the capsule.
These capsules can only store medications in liquid or semi-liquid form. After filling the capsule with the substance, seal the capsule and leave it to cool. Soft gelatin capsules usually have a thicker and more flexible shell compared to hard capsules. The sealing process helps to keep your product tamper-proof and safe.
Each step involved in the manufacturing process plays a role in maintaining good structure and proper function of these capsules.
Capsule Structure
Hard Gelatin Capsule
Hard gelatin capsules have a two-piece structure; a body and a cap. The body stores the medication which could be powder, granules, or pellets, while the cap covers the body. Gelatin is the primary ingredient used in producing these two parts.
Also, you need to manufacture these two parts separately before you fill with substance and cover. Hard capsules aren’t ideal for liquid substances unless you will be applying a special sealing. Due to their two-piece structure, you can store dual-drug in a single unit.
Soft gelatin Capsules
These are one-piece capsules that require simultaneous filling and sealing during their production. The main ingredients used in making the shell is gelatin and water. This shell is thicker and more flexible than that of hard capsules.
Also, the manufacturing process ensures proper sealing to prevent leakage or active ingredients from oxidizing.
Shell Composition
Hard Gelatin capsules comprise gelatin, water and some colorants. These capsules are usually very dry and rigid because they don’t contain plasticizers. Their dry shell makes them perfect for storing and delivering medications in powder or granule form.
On the other hand, soft gelatin capsules comprise water, gelatin, and plasticizers. You will notice that soft gelatin capsules are always flexible and elastic. The plasticizer in these capsules is responsible for this flexibility. This texture makes these capsules ideal for encapsulating liquid or semi-liquid substances.
Some soft gelatin capsules contain flavoring agents and preservatives to help them last longer. The ingredients used in producing the shell play a significant role in how you easily digest the capsule. Generally, soft capsules digest faster once you consume them. This makes them perfect for certain medications.
Capsule Bioavailability
Due to the shell composition of soft capsules, they have exceptional bioavailability. This means they can easily absorb in your bloodstream when consumed.
The presence of pre-dissolved ingredients or emulsifiers aids quick absorption. Due to this feature, pharmaceutical companies use soft gel to deliver vitamin supplements and fat-soluble medications that require fast absorption.
The shell formulation of hard capsules is responsible for their low bioavailability. Pharm companies use these capsules to store and deliver drugs in powder, pellets or granules form. These capsules don’t easily absorb in your bloodstream. However, some companies integrate Modified-released fills to help you quickly absorb these medicines.
Generally, hard gelatin capsules enable customization in release profiles while soft gelatin capsules have improved immediate-release capability. When choosing between these two capsules, you need to consider the absorption requirements of the active ingredients of the medication.
Capsule Manufacturing Cost
The production of hard gelatin capsules requires less cost due to their two-piece structure. This is because you can perform the filling and sealing process separately since it stores dry substances only. Also, you don’t need specialized machinery to produce these capsules. This helps to reduce overhead cost and manufacturing complexity.
You need more advanced machinery to produce soft gelatin capsules. The production process requires you to fill and seal the shell simultaneously. During this process, you need to ensure a good balance between humidity and temperature for a successful production.
Softgels are costly to produce because it requires more effort and capital. The machineries used in their production are very expensive. Also, the inclusion of plasticizers in their production adds to the manufacturing cost. Although they have higher bioavailability, they are more costly to produce.
Fill Material in Capsules
Hard Gelatin capsules are ideal for encapsulating solid substances like mini-tablets, pellets, powder, and granules. Due to the texture of their fill material, you can combine two or more active ingredients in one capsule. With hard gelatin capsules, it is easier to achieve modified-release impacts. This benefit makes them suitable for medications that need slow release and precise dosing.
Soft gelatin capsules are suitable for storing liquid or semi-liquid substances like suspensions, oils, emulsions, and more. These capsules offer air-tight and tamper-proof seals, thereby protecting their fill material. Therefore, these capsules are ideal for vitamins and fat-soluble medications.
When choosing between hard gelatin capsules and softgels, the fill material is the major deciding factor. This factor determines the stability and release profiles of a medication.
Capsule Dissolution
The material used in the production of hard gelatin capsules determine their dissolution. Hard capsules take about 5-10 minutes to dissolve in your stomach after consuming. Sometimes, the time of dissolution varies based on the formulations in the capsule.
This is because some hard capsules contain excipients or other materials that make them slowly release medications in your bloodstream. Some capsules activate intestinal absorption immediately, bypassing stomach absorption.
Softgels are very quick to dissolve and absorb by your body. Their dissolution takes a few minutes, all thanks to their shell composition. Due to this, pharmaceutical companies use these capsules for storing lipophilic, vitamin supplements, and fat-soluble medications.
Also, softgels ensure active ingredients have even dispersion, which helps to ensure consistent results. Softgels start dissolving right after you consume them while hard capsules take time to release medications.
Applications
The shell formulation and fill material of hard gelatin capsules determine their applications. You can only use hard gelatin capsules for storing and delivering solid medications in the form of granules, powder, or pellet. Also, these capsules have a two-piece structure which makes it convenient to combine multiple ingredients in them.
You can use them for over-the-counter medications, modified-release drugs, herbal supplements, and prescription drugs that don’t need quick absorption.
It is appropriate to use soft gelatin capsules during storage purposes and when delivering partly or fully-liquid medications. Their flexible and thick shell makes them ideal for water-soluble formulations. These capsules are commonly used for nutrients like vitamins A, D, and E.
They are a common option for encapsulating medications in the cosmetics and nutraceutical industries. Their quick bioavailability makes them suitable for use in these industries.
Conclusion
Comparing soft and hard gelatin capsules deals with the manner at which you wish to deliver these capsules to consumers. If you plan to save costs, then you should work with hard gelatin capsules. However, if you prefer to deliver capsules that are easy to swallow, then you should choose the soft gelatin types. To manufacture the best hard gelatin capsules, you should choose the best capsule filling machines from Saintytec. Check their catalog today to learn about their amazing offers.
FAQ
What are the cons of hard gelatin capsules?
Hard gelatin capsules could break easily during humid conditions. They don’t retain liquids properly, and for several drugs, their release is slower. In addition, they may not be appropriate for ingredients that are sensitive to moisture.
What can you use softgel capsules for?
The common use of softgel capsules is to deliver vitamins (fat-soluble), oils, as well as other drugs (semi-liquid or liquid), which needs a more effective bioavailability and quick absorption.
What benefits does hard gelatin capsule offer?
Hard gelatin capsules are cost-effective. They deliver great stability and you can easily fill it using pellets or powders. Also, they permit flexible construction for your custom dosing.
What are the cons of softgel capsules?
Manufacturing softgel capsules are usually more expensive to manufacture. They are also sensitive to moisture and heat and aren’t suitable for formulations that are water-based.
What benefits does soft gelatin capsules offer?
You can easily swallow softgels and they allow you to absorb the drug faster. Also, they prevent liquid ingredients from leaking out and they provide better stability of compounds that are sensitive like oils.
