Soft Gelatin Capsules
Soft gelatin capsules are also known as softgels or soft elastic capsules. They differ from hard gelatin capsules in many ways;
The capsule shell is mainly made and filled at the same time.
Read more - Hard Gelatin Capsules | Manufacturing Methods
The commercially filled soft gelatin capsules are available in a vast variety of shapes round, oblong and tubular in shapes.
Softgels are the type of capsules in which through the addition of plasticizers, the mechanical properties of the gelatin have been exploited or manipulated.
By the addition of glycerin, sorbitol, or other material that is suitable, the gelatin is plasticized which provides the shell better flexibility.
Preservatives are frequently added into the formulations of capsule shells to prevent fungal as well as microbial growth.
Generally, softgels are filled with liquids, then the drug is dispersed or dissolved into a solvent.
The oral bioavailability of poorly water-soluble drugs can be increased when the drug is dissolved into the fill liquid or solvent.
The selection of solvents is depending upon the physicochemical properties of the drug, the presence of other additives, and also the volume as well as the weight of the drug content.
The stability of the product is depending upon the properties of the capsule shell, and the condition in which it stores and fills content.
In recent years the popularity of soft gelatin capsules has increased because of the ability to formulate liquid-based formulations.
The commercially filled soft gelatin capsules are available in a vast variety of shapes round, oblong and tubular in shapes.
Softgels are the type of capsules in which through the addition of plasticizers, the mechanical properties of the gelatin have been exploited or manipulated.
By the addition of glycerin, sorbitol, or other material that is suitable, the gelatin is plasticized which provides the shell better flexibility.
Preservatives are frequently added into the formulations of capsule shells to prevent fungal as well as microbial growth.
Generally, softgels are filled with liquids, then the drug is dispersed or dissolved into a solvent.
The oral bioavailability of poorly water-soluble drugs can be increased when the drug is dissolved into the fill liquid or solvent.
The selection of solvents is depending upon the physicochemical properties of the drug, the presence of other additives, and also the volume as well as the weight of the drug content.
The stability of the product is depending upon the properties of the capsule shell, and the condition in which it stores and fills content.
In recent years the popularity of soft gelatin capsules has increased because of the ability to formulate liquid-based formulations.
Various Components of Soft Gelatin Capsule Shell
The various components of a softgels shell are gelatin, plasticizing agents, water, colorants or opacifier, preservatives, and miscellaneous excipients.
Gelatin
In soft elastic capsules manufacturing, generally, type B which is alkali-processed gelatin is used. Although, type A which is acid-processed gelatin may also be used.Plasticizing Agents
The mechanical properties of the soft elastic capsules are regulated by the concentration of plasticizers.Polyhydric alcohols such as sorbitol or glycerol or a mixture of glycerol and sorbitol are used for this purpose.
The concentration of plasticizers that should be generally used is 20% w/w of the wet mass.
This concentration range is a very important consideration of the mechanical properties of soft elastic capsules.
If the concentration used in excess is 30% w/w, then it will result in the capsule becoming too flexible.
If the concentration of plasticizers is below 20% w/w then it will result in the capsule becoming too brittle or hard.
So, in both cases, the splitting of the capsule can occur either during use or in storage.
The ratio of the plasticizer to gelatin is 0.4:1.0 and 0.8:1.0 (hard and soft) defines the hardness of the finished soft gelatin capsules that proposed the mechanical properties.
Water
During the manufacturing process to enhance the manufacture and also in the finished product to ensure that the capsule is flexible, water is required in both cases and plays a vital role.In the initial stage of the manufacturing of soft elastic capsules, the water concentration should be between 30% to 40% w/w of the wet mass.
Although, following the formation of capsules, it is exposed to controlled drying that results in the final capsule water content of 5% to 8% w/w. If the capsule gets overdried then that will result in a brittle or hard capsule.
Preservatives
During the storage, to prevent bacterial growth as well as moulds in the solution of gelatin, preservatives are added like methyl, ethyl, and propyl hydroxybenzoate, potassium sorbate.Miscellaneous Excipients or Types of Vehicles Used in Soft Gelatin Capsules
Soft elastic capsules can be colored or opaque.During the manufacturing process, the colors or opacifiers may be added that are to be chosen.
These colors enhance the visual appearance of soft gelatin capsules.
Titanium dioxide is mainly used as an opacifier for soft gelatin capsules.
Additionally, if required, flavoring agents may be added to the capsule shell so that palatability can be enhanced.
It is to be noted that the excipients selection and their concentration depend upon the active ingredients as well as the formulation of the soft gelatin capsule.
Advantages of Soft Gelatin Capsules
There are many advantages of soft gelatin capsules used as a solid oral dosage form as well as supplements. A few important advantages are as follows;
Easy to Swallow
The soft gelatin capsules are small in shape, and easy to swallow so they can be taken either with or without water.Improved Stability
For certain sensitive ingredients, the soft gelatin capsules provide improved stability because they are resistant to light and moisture.Increased Bioavailability
As soft gelatin capsules are absorbed more quickly and efficiently by the body so, they may improve the bioavailability of some drugs.Customizable
As per the requirement of the manufacturer as well as the customers the soft gelatin capsules can be customized in terms of shape, size, color, and printing.Flexibility in Formulation
The formulations of soft gelatin capsules can be done with a large range of active ingredients also soft gelatin capsules can be filled with liquids, semisolids, and suspensions.Cost-Effective
Soft gelatin capsules are relatively less expensive to formulate and also available vary widely.Aesthetically Pleasing
The soft gelatin capsules can be made in a variety of colors which may add a visual appeal and these are translucent or transparent, which makes them aesthetically pleasing.Masking Unpleasant Taste
The soft gelatin capsules formulate to mask the unpleasant taste of active ingredients and also make them more palatable for patients who are not able to take the other dosage forms like a tablet.Read more - Capsules - What kind of pill is a capsule
Targeted Release
Soft gelatin capsules are formulated to release the active drug ingredients in a particular area of the body at a specific time, which increases the efficacy and also minimizes the side effects.Convenience
Soft gelatin capsules can be stored easily, transported, and can be taken either with or without water. Refrigeration is not required for soft gelatin capsules.Enhanced Patient Compliance
Soft gelatin capsules can enhance patient compliance as they are easy to swallow and can be taken at any time, which can help patients to stick to their medication schedule.Disadvantages of Soft Gelatin Capsules
Soft gelatin capsules are not more stable as compared to other types of capsules like hard gelatin capsules which makes them more sensitive to degradation such as in high temperatures and high humidity.Soft gelatin capsules are not suitable for some types of active ingredients like those that are highly alkaline or highly acidic.
Some people may also have an allergic reaction to the gelatin that is used in their manufacturing process.
Soft gelatin capsules are more difficult to formulate and filled as compared to the other types of capsules. Due to this, the production cost gets increased and a higher risk of defects or errors may occur.
Read more - What are 4 types of capsules
Soft gelatin capsules are not suitable for all types of drugs mainly those that are sensitive to light and moisture.
Some soft gelatin capsules are known to have an unpleasant taste as well as odor that can affect patient compliance.
Soft gelatin capsules are not recommended for use in animals.
There is a special type of manufacturing equipment is required for the production of soft gelatin capsules.
Read more - What is the tablet dosage form?
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