capsules Flashcards
These are the most preferable dosage form when taken orally, as it is conveniently carried, readily identified and easily taken.
Capsules and Tablets
Are solid pharmaceutical dosage forms in which the drug or a mixture of drugs is enclosed in a Gelatin Shell or any other suitable material.
Capsules
Main types of capsules
Soft Gelatin Shell
Hard Gelatin Shell
The shells of a capsule may be composed of two pieces:
a body
a cap
Two-piece capsules are commonly referred to as:
hard-shell capsules
One-piece capsules are often referred to as:
soft-shell capsules
These are used in most commercial medicated capsules.
Hard Gelatin
The empty capsule shells are made of
___________. As such, they can be clear, colorless, and essentially tasteless
gelatin, sugar, and water
Hard gelatin capsule shells are manufactured in two sections:
body and a shorter cap
Made of gelatin to which glycerin or
a polyhydric alcohol such as sorbitol has
been added.
Soft Gelatin Capsule
Soft gelatin contain more moisture than hard capsules.
Are used to encapsulate and hermetically seal liquids, suspensions, pasty materials, dry powders, and even preformed tablets.
They are pharmaceutically elegant and are easily swallowed.
Soft Gelatin Capsules
Capsules are available in many different sizes and shapes and can be used for the administration of powders, semisolids and liquids.
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- First step in the process involves an acceptability test for raw materials.
The materials that pass this test are then melted and coloured for easy identification.
Step 1: Raw Material Melting and Coloration
In this step, gelatin solution is blended and dissolved in de-mineralised water heated to seventy degrees Celsius.
The solution at this stage is very Viscous and contains 30 to 40% gelatin.
Step 2: Blending
The capsule manufacturing machines receive coloured gelatin in the capsule processing chamber.
The caps and bodies of the capsules are made.
Step 3: Molding and Trimming
This stage includes all vital information, such as prescription recommendations, advertisements, and capsule branding.
Step 4: Printing and Packaging
After the printing phase is completed, the quality testing phase begins.
The end products must undergo stringent quality inspections to ensure that the capsules are of the best quality and possess a long shelf life.
Step 5: Testing, Packaging & Shipping
Hard Gelatin Capsule Manufacturing Process
1: Raw Material Testing and Coloration
2: Blending
3: Molding and Trimming
4: Printing and Packaging
5: Testing, Packaging, and Shipping
A soft-gel shell is formed to contain and protect the fill material.
1: Gelatin Preparation
Fill materials for soft-gels come in a variety of forms, such as liquids, oils, suspensions, or semi-solids
2: Fill Material Preparation
Most soft gelatin capsules are produced by a method called the rotary die encapsulation process.
3: Encapsulation
Following encapsulation, the formed soft-gel capsules fall onto a conveyor.
The conveyor transfers them to the next step – soft-gel drying.
4: Drying
Following complete drying, the soft gel capsules should be transferred to the inspection station for quality control. This is an important step In the soft gel manufacturing process.
5: Inspection and Sorting
After sorting out qualified soft-gels, you can use a soft- gel polishing machine to remove any oil residue or debris from the soft-gel surface.
6: Cleaning and Polishing
Soft Gel Manufacturing Process
1: Gelatin Preparation
2: Fill Material Preparation
3: Encapsulation
4: Drying
5: Inspection and Sorting
6: Cleaning and Polishing
An automatic capsule filling machine is manufactured and designed to directly fill up capsules with pharmaceutical powders without any operator dependability.
Automatic Filling of Powder Formula
This machine is a hybrid machine that is a mixture of both the automatic and manual capsule filler machines.
Semi-Automatic Capsule Fillers
Manual capsule filler is used mostly at an individual level and can be used in industries where the amount that needs to be filled with the exact amount of ingredients.
Manual Filling of Powder Formula
Methods for Filling the Capsules
Automatic Filling of Powder Formula
Semi-Automatic Capsule Fillers
Manual Filling of Powder Formula
These are often referred to as “inactive ingredients” because, in drugs, they comprise of everything except the active pharmaceutical ingredients (APIs).
Excipients
It improves water penetration for poorly soluble drugs e.g. Sodium lauryl sulfate.
Wetting Agent
It produces disruption of the powder mass crospovidone, sodium starch glycolate.
Disintegrants
They act as fillers in pharmaceutical tablets to increase weight and improve content uniformity.
Examples: mannitol, microcrystalline cellulose, lactose, pregelatinized starch 1500, corn starch, etc.
Diluentw
It is used to improve the fluidity of the contents. Commonly used glidants are micro-silica gel and talcum powder.
Glidants
These are used to prevent the adhesion of powder to metal materials. Common materials include magnesium stearate, glyceryl monostearate, stearic acid, talc, etc.
Lubricants
Hard Gelatin Equipment
Gelatin Melting Tanks
Feed Tanks
Pin Bars
Stripper
Joiner Block
Manual Filler
Semi-Automatic Filler
Automatic Filler
Soft Gelatin Equipment
Rotary Die Machine
Soft Gelatin Equipment
Rotary Die Machine
