If you want to form capsules in bulk, it is crucial to understand the basic words used for the capsule manufacturing process.
Read this guide to get information about all the definitions of capsule manufacturing. This could help you produce effective drugs by solving any problem associated with manufacturing.
Let’s move into it:
Active Pharmaceutical Ingredient (API)
API is an active ingredient used to make the final drug. This term is also referred to as an active substance in medicinal capsules. These capsules include vitamins, minerals, natural extracts, supplements, pharmaceutical drugs, etc.
Altered Release
The content a capsule releases as the final product is controlled by controlling the material used and drug formulation. The hydrophobicity of drug formulation and the capsule’s ingredients play a role in the quick-release of drugs.
The capsule shells are altered by making its coating semi-permeable. This relates to the enteric coating technique that protects the capsule’s ingredients until it reaches the digestive system.
Auger Filling Machine
When capsules are made in a capsule-making machine, there is a rotating screw known as an auger. It moves the powder from the hopper to each capsule. The auger rotates to help in the smooth flow of powder.
The amount of product which should go into each capsule, its retention time in hopper and speed of auger is decided by the size of the capsule. The lower the speed of auger rotation, the more powder is filled in the capsule.
Body
The part of the capsule that carries powder before cap fitting is known as the body of the capsule.
Caps
The upper part of the capsule that covers the body is known as caps. The empty capsule is called hard caps or simple caps.
Capsule
A capsule is a stable container which carries active ingredients. It also ensures that the active substance is suitable for intake and suppositories.
Hard Capsules
The capsules, which we made with gelatin or HPMC are called hard capsules. It also contains two parts, one is the body and the other is the cap.
Soft Capsules
The capsules which are used to carry oils or oil type ingredients are called soft capsules. These capsules are produced with a continuous process These are also designed to hold the liquid substance inside the body.
Capsule Filler
Hard capsules are filled with the help of filling machines, which come in three forms:
- Manual Capsule Filler: When capsules are filled by humans are called manual capsule fillers.
- Semi-Automatic Capsule Filling Machine: When the filling is done by a person but little automatic process could be done, then it’s called a semi automatic capsule filling machine.
- Fully Automatic Capsule Filling Machine: The machines in which the complete filling is done through machines is known as fully automatic capsule filling machine.
Colourant
When the capsules are produced, some coloring agent are added in the gelatin solution of capsules. There are two main types of colorants, including:
- Water-soluble dyes: Common colorants which are added includes indigo, carmine, erythrosine, and quinoline yellow.
- Insoluble pigments. Common pigments are iron oxide and titanium dioxide. Iron oxide comes in black, red and yellow color. Titanium dioxide is white and makes your capsules opaque.
Dependent Filler
It’s a capsule dosing machine. This is used to measure the exact amount of powder product, which is added in the body. The capsules should be completely filled for accurate measuring. This is possible through an auger filling machine.
Diluent
A substance added in large amounts in the formulation is known as a diluent. It is added when there is not enough active ingredient. Some examples include maize starch, calcium sulfate and lactose.
Dosator
A hard capsule filling machine’s part is known as dosator. This measures the powder of the body separately and accurately with a measuring device. The weight consistency of the powder is not dependent on the filling process of capsules.
Disintegrant
These are substances added to the capsules or tablets to help them break in water. This helps in increasing the surface area of the drug. It also enables that drug to be released quickly. Cornstarch and microcrystalline cellulose are common examples of disintegrants.
Dry Granulation
A method used to create granules from powder without using liquid is known as dry granulation. This method is applicable for sensitive substances or those that are heat and moisture-sensitive.
Without adding liquid, powder is compressed and densified under high pressure. For this process, a high-shear mixer granulator is used.
Drying Oven
To remove moisture from various substances, a drying oven device is used. It is commonly used to prepare powder and form gelatin capsules. Beside this the drying ovens could be replaced with kilns, because it could not bear high temperature.
In the hard capsules, the gel is created at room temperature, dried at various temperatures. But in soft gel the water content comes with 30 to 40%. This water content reach 10% when capsule crossed different dried oven
Enteric Coating
Some capsules come with an enteric coating. Therefore the capsules remain in interaction in the acidic environment of the stomach. And the same capsules dissolve in the basisity of the intestine. This coating is usually done with cellulose acetate phthalate and other waxes.
Gelatin
A mixture formed from protein and peptides is known as gelatin. Gelatin is made when collagen is partially breaking down from an animal source. It also comes from cattle bones, pig skin and fish bones.
Gelcap: A name used for gelatin capsules.
Granulation
The process to make granules from bonding the powder substance is known as granulation. Bonding of powdered substance could occur by adding a binding agent or by compressing the substances. This process is necessary to get desired quality capsules or tablets, like for consistent content and hardness.
Granules
A small cluster of particles that make up medicinal powder is known as granules. This term is specially used in the pharmaceutical industry. These granules usually come with a bitter taste. When these are compressed to form capsules, people can engulf it without tasting it.
Process Aids
Some preservatives and surfactants are added to the gelatin solution. These help in spreading the liquid and improve the manufacturing process. Thus, these are called process aids.
Plasticizer
A substance used in the gelatin to make softgel capsules is known as plasticizer. Common plasticizers are glycerol, propylene glycol and sorbitol. Usually these make the 20 to 30% weight of gelatin which we use in softgel capsule formation.
Soft Gel
A softgel is a medicine which patients intake through the mouth. Its shell is made up with gelatin and contains liquid inside. A mixture of water, gelatin, glycerin, and opacifier ingredients forms soft gel.
Rotary Capsule Machine
A machine whose two sides are cylindrical and each comes with a mold cut. Then the cylinders rotate in different directions. There are two ribbens of gelatin inserted in these rollers. A jet spray is filled in each half mold before rollers motion.
After this a pressure is applied between two halves to keep them close. Ultimately a capsule is formed. This machine can form 25 thousands to thirty thousands capsules in one time.
Globex Method
With the help of a drop formulation technique, seamless capsules are created with two concentric tubes. An active ingredient is fed in the inner tube while the gelatin is in the outer tube.
The mixture then falls on an inert liquid where gelatin does not dissolve. Through this process spherical drops are formed. The size of these drops is controlled with the machine’s regular pulsed flow. To solidify gelatin the bath is kept at 4 degrees celsius, and ultimately capsules are dried.
Wet Granulation
When granules are formed by mixing powder ingredients with liquid solution, then it’s called wet granulation. The mixing causes the particles together, which ultimately form wet granules.
Excipients
The inactive substances used in pharmaceutical products are known as excipients. These are used to enhance the flavor of the substance. It also controls how an active ingredient of the capsule releases. An excipient also ensures the stability of products.
Bioavailability
The measure of how much and quickly the drug’s active ingredients could be absorbed in the blood is known as its bioavailability. This is important for the effectiveness of drugs.
Stability
This term is related to how much a drug can maintain its chemical composition and physical characteristics with time. To ensure a drug’s effectiveness and safety, understanding its stability is crucial.
Dosage Form
This is a term used in medicinal physics, like for tablets or capsules. The dosage form that is taken directly affects the administration route and drug release rate. It also relates to the extent a patient accepts it.
Good Manufacturing Practices
The principles that ensure that products are made up consistently and fall on quality standards are commonly called GMP. To maintain quality, a good GMP is necessary.
Conclusion
After getting complete knowledge about the terms that are used in capsule production, now you can better understand the capsule manufacturing process. Additionally, you can address any uncertain issue during production.