Capsules and Tablets Flashcards
___ together with ___ are the most
preferable dosage form when taken orally, as it is conveniently carried, readily identified and easily taken.
Capsules; tablets
Capsules are solid pharmaceutical dosage forms in
which the drug or a mixture of drugs is enclosed in a ___ or any other suitable material.
Gelatin Shell
Advantages of Capsules
- Attractive in appearance
- Tasteless, odorless, and easily administered
- Mask the taste and odor of unpleasant drugs
- Easy to handle and carry
- The shells are physiologically inert and easily and quickly digested in the gastrointestinal tract.
- Slippery when moist and, hence, easy to swallow with a draught of water.
Disadvantages of Capsules
- Not suitable for liquids that dissolve gelatin
- Not useful for efflorescent or deliquescent materials.
- Concentrated solutions which require previous dilution are unsuitable for capsules because if
administered as such lead to irritation of the stomach.
Main Types of Capsules
- Hard Gelatin
- Soft Gelatin
The shells of the capsules may be composed of two pieces:
a body and a cap
Two-piece capsules are commonly referred to as ___
hard-shell capsules
One-piece capsules are often referred to as ___
soft-shell capsules
Are used in most commercial medicated capsules.
Hard Gelatin
The empty capsule shells
are made of ___ , ___ , and ___ . 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 ___ moisture than hard capsules.
more
Soft Gelatin capsules used to encapsulate and hermetically seal
___ , ___ , ___ , ___ , and even ___ .
liquids;
suspension;
pasty materials;
dry powders;
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.
000
00
0
1
2
3
4
5
Steps in Hard Gelatin capsule manufacturing process (5)
Step 1: Raw Material Melting & Coloration
Step 2: Blending
Step 3: Molding and Trimming
Step 4: Printing and Packaging
Step 5: Testing, Packaging, and Shipping
First step in the process involves an acceptability test for raw materials. The materials that pass this test are then melted and colored for easy identification.
Step 1: Raw Material Melting and Coloration
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 colored
gelatin in the capsule processing chamber. The caps and bodies of the capsules are made.
Step 3: Molding and Trimming
The printing 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 and Shipping
Steps in Hard Gelatin capsule manufacturing process (6)
Step 1: Gelatin Preparation
Step 2: Fill Material Preparation
Step 3: Encapsulation
Step 4: Drying
Step 5: Inspection and Sorting
Step 6: Cleaning and Polishing
A soft-gel shell is formed to contain and protect the fill material.
Step 1: Gelatin Preparation
Fill materials for soft-gels come in a variety of forms, such as liquids, oils, suspensions, or semi-solids
Step 2: Fill Material Preparation
Most soft gelatin capsules are produced by a method called the rotary die encapsulation process.
Step 3: Encapsulation
Following encapsulation, the formed soft-gel capsules fall onto a conveyor. The conveyor transfers them to the next step – soft-gel drying.
Step 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.
Step 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.
Step 6: Cleaning and Polishing
Methods for Filling the Capsules (3)
- Automatic Filling of Powder Capsule
- Semi-Automatic Capsule Fillers
- Manual Filling of Powder Formula
Is manufactured and designed to directly fill up capsules with pharmaceutical powders without any operator
dependability.
Automatic Filling of Powder Capsule
Is a hybrid machine that is a mixture of both the automatic and manual capsule filler machines.
Semi-Automatic Capsule Fillers
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
Are often referred to as “inactive ingredients” because, in drugs, they comprise of everything except the active pharmaceutical ingredients (APIs).
Excipients
Excipient Added in Capsules (5)
- Wetting agents
- Disintegrants
- Diluents
- Glidants
- Lubricants
Improve water penetration for poorly soluble drugs
Wetting agents
Example of wetting agent (1)
Sodium lauryl sulfate
Produce disruption of the powder mass crospovidone, sodium starch glycolate.
Disintegrants
Act as fillers in pharmaceutical tablets to increase weight and improve content uniformity
Diluents
Examples of Diluents (5)
- Mannitol
- Microcrystalline cellulose
- Lactose
- Pregelatinized starch 1500
- Corn starch
Is used to improve the fluidity of the contents.
Glidants
Commonly used glidants: (2)
- Micro-silica gel
- Talcum
Use to prevent the adhesion of powder to metal materials.
Lubricants
Common lubricants: (4)
- Magnesium stearate
- Glyceryl monostearate
- Stearic acid
- Talc
Hard Gelatin Equipment (8)
- Gelatin Melting Tanks
- Feed Tanks
- Pin Bars
- Stripper
- Joiner Block
- Manual Filler
- Semi-Automatic Filler
- Automatic Filler
Soft Gelatin Equipment (1)
Rotary Die Machine
According to the US Pharmacopoeia, it is a compressed solid dosage form containing medicaments with or without Excipients.
Tablet
Tablet is the most popular dosage form, ___ total medicines are dispensed in the form of it.
70%
Are solid, flat or biconvex dishes, unit dosage form, prepared by compressing a drug or a mixture of drugs, with or without diluents.
Tablets
Advantages of Tablets
From patients standpoint: (3)
- Easy to administer
- Unpleasant taste can be masked
- Accuracy in dose
Advantages of Tablets
From manufacturer standpoint: (3)
- Stable
- Economical
- Easiest and Cheapest to package and ship
Disadvantages of Tablets: (5)
- Challenging for children and unconscious patients.
- Compression problems with crystalline drugs.
- Unsuitable for hygroscopic drugs.
- Difficulties with slow-dissolving drugs.
- Added costs for taste masking through coating/encapsulation.
General Properties of Tablet Dosage Form: (4)
- Defect-free and elegant.
- Withstand shocks.
- Maintain physical and chemical integrity.
- Consistent medicinal agent release.
Types of Tablets: (4)
- Tablets ingested orally
- Tablets used in the oral cavities
- Tablets administered by other routes
- Tablets used to prepare solutions
TYPES OF TABLETS
Tablets ingested orally: (7)
- Compressed tablets
- Multiple compressed tablets
- Enteric coated tablets
- Sugar coated tablets
- Film coated tablets
- Chewable tablets
- Sustained action tablets
TYPES OF TABLETS
Tablets used in the oral cavities: (4)
- Buccal tablets
- Sublingual tablets
- Lozenges
- Dental Cones
TYPES OF TABLETS
Tablets administered by other routes: (2)
- Implantation tablets
- Vaginal tablets
TYPES OF TABLETS
Tablets used to prepare solutions: (4)
- Effervescent tablets
- Dispensing tablets
- Hypodermic tablets
- Tablet triturates
TABLETS INGESTED ORALY
Formed by compression and
contain no special coating. It provides rapid disintegration in gastric fluid after ingestion, allowing for quick absorption of the dosage form.
Compressed Tablets
TABLETS INGESTED ORALY
Example of Compressed Tablets:
- Paracetamol
- Aspirin
TABLETS INGESTED ORALY
Tablets made by more than one compression cycle.
Multiple Compressed Tablets
TABLETS INGESTED ORALY
Meant for administration by swallowing and are designed to by-pass the stomach and get disintegrated in the intestine only.
Enteric Coated Tablets
TABLETS INGESTED ORALY
Example of Enteric Coated Tablets:
- Bisacodyl tablet
TABLETS INGESTED ORALY
Containing a sugar coating. These are done to mask the bitter and unpleasant odor and the taste of the medicament.
Sugar Coated Tablets
TABLETS INGESTED ORALY
Example of Sugar Coated Tablet
Ascorbic Acid (Poten-Cee)
TABLETS INGESTED ORALY
Tablet that has a film coating of
some polymer substance, such as hydroxy propyl cellulose. This protects the medicament from
atmospheric effects.
Film Coated Tablets
TABLETS INGESTED ORALY
Example of Film Coated Tablets:
- Sildenafil (Viagra)
TABLETS INGESTED ORALY
Tablets which are required to be broken and chewed in between the teeth before ingestion. These tablets should have very acceptable taste and flavor.
Chewable Tablets
TABLETS INGESTED ORALY
Example of Chewable Tablet:
Simeticone (Restime)
TABLETS INGESTED ORALY
Release the drug at a desired time and prolong the effect of the medicament. This release the medicament in a sufficient quantity and as when required to maintain the maximum effective
concentration of the drug in the blood throughout the period of treatment.
Sustained Action Tablets
TABLETS INGESTED ORALY
Example of Sustained Action Tablets:
Diclofenac SR
TABLETS USED IN THE ORAL CAVITIES
Placed between the gum & lip or cheek. This dissolves slowly & absorb directly.
Buccal Tablets
TABLETS USED IN THE ORAL CAVITIES
Example of Buccal Tablets:
- Progesterone
TABLETS USED IN THE ORAL CAVITIES
Placed under the tongue. This dissolves quickly and absorbed directly without passing into GIT
Sublingual Tablets
TABLETS USED IN THE ORAL CAVITIES
Example of Sublingual Tablets:
- Nitroglycerin
TABLETS USED IN THE ORAL CAVITIES
This designed to exert a local mouth or throat.
Lozenges
TABLETS USED IN THE ORAL CAVITIES
Example of Lozenges:
Strepsils
TABLETS USED IN THE ORAL CAVITIES
These are minor compressed tablet meant for placing them in the empty socket after tooth extraction. These cones generally get dissolved in 20-40 minutes time
Dental Cones
TABLETS USED IN THE ORAL CAVITIES
Example of Dental Cones:
Advil
TABLET ADMINISTERED BY OTHER ROUTES
This tablet placed below the skin
or subcutaneously by means of a minor surgical operation and are slowly absorbed.
Implantation tablets
TABLET ADMINISTERED BY OTHER ROUTES
Example of Implantation tablets:
- Prodetoxon
TABLET ADMINISTERED BY OTHER ROUTES
This tablet are meant to dissolve slowly in vaginal cavity.
Vaginal Tablets
TABLET ADMINISTERED BY OTHER ROUTES
Example of Vaginal Tablets:
Clotrimaxole
TABLET USED TO PREPARE SOLUTIONS
This is meant to add in water. They dissolved rapidly in water due to the chemical reaction which takes place between alkali bicarbonate and citric acid.
Effervescent Tablets
TABLET USED TO PREPARE SOLUTIONS
Example of Effervescent Tablets:
- Ranitidine (Histac)
TABLET USED TO PREPARE SOLUTIONS
This is intended to a given volume of water to produce a solution of a given concentration.
Dispensing Tablet
TABLET USED TO PREPARE SOLUTIONS
Example of Dispensing Tablet:
- Enzyme Tablet (DigiPlex)
TABLET USED TO PREPARE SOLUTIONS
This is a compressed tablet that
contains one or more dugs. It is dissolved in sterile water and administered parenterally.
Hypodermic Tablets
TABLET USED TO PREPARE SOLUTIONS
These are small cylindrical, moulded or compressed tablet which contains a potent medication with a diluent.
Tablet Triturates
TABLET USED TO PREPARE SOLUTIONS
Example of Tablet Triturates:
- Enzyme tablet (DigiPlex)
EXCIPIENTS IN TABLETS FORMULATION
Fillers used to make the required bulk of the tablet. Provide better tablet properties such as
improved cohesion
Diluent
EXCIPIENTS IN TABLETS FORMULATION
Characteristics of an ideal diluent: (6)
- Non-toxic and low cost
- Commercially available in an acceptable grade
- Cheap compared to the active ingredients and physiologically inert
- Chemically stable alone and in combination with the drug(s)
- Color-compatible
- No negative effects on the bioavailability of the drug(s)
EXCIPIENTS IN TABLETS FORMULATION
The most widely used diluent for tablet formulation. It is obtained in hydrous and anhydrous form.
Lactose
EXCIPIENTS IN TABLETS FORMULATION
Two grades of lactoses are commercially available
- 60 to 80 mesh – coarse
- 80 to 100 mesh – regular grade
EXCIPIENTS IN TABLETS FORMULATION
Advantages of Lactose: (3)
- No reaction to most of the drugs
- Good release rates
- Low cost
EXCIPIENTS IN TABLETS FORMULATION
Disadvantages of Lactose: (1)
- Reacts with amine drug bases in presence of alkaline lubricants
EXCIPIENTS IN TABLETS FORMULATION
It has excellent compressibility
properties
Spray Dried Lactose
EXCIPIENTS IN TABLETS FORMULATION
Advantages of Spray Dried Lactose: (2)
- Used for direct compression
- Good flow characteristics
EXCIPIENTS IN TABLETS FORMULATION
Disadvantages of Spray Dried Lactose: (2)
- The material loses some of its direct compressional characteristics.
- Prone to darkening in the presence of excess moisture, amines, and other compounds.
EXCIPIENTS IN TABLETS FORMULATION
Obtained from corn, wheat or potatoes and rice. It is occasionally used as a tablet diluent.
Starch
EXCIPIENTS IN TABLETS FORMULATION
Directly Compressible Starches: (2)
- Sta-Rx 1500
- Emdex and Celutab
EXCIPIENTS IN TABLETS FORMULATION
Free-flowing, directly compressible starch. It
is used as diluent, binder, and disintegrant.
Sta-Rx 1500
EXCIPIENTS IN TABLETS FORMULATION
Are two hydrolyzed starches - contains dextrose and maltose.
Emdex and Celutab
EXCIPIENTS IN TABLETS FORMULATION
Dextrose (D-Glucose)
Available in two forms:
- Hydrates
- Anhydrous
EXCIPIENTS IN TABLETS FORMULATION
Advantages of Mannitol: (3)
- Its slow solubility, and its pleasant feeling in the mouth
- Non-hygroscopic
- Low calorie and non-carcinogenic.
EXCIPIENTS IN TABLETS FORMULATION
Disadvantage of Mannitol:
Costly and has poor flow characteristic
EXCIPIENTS IN TABLETS FORMULATION
Is an optical isomer of mannitol
Disadvantages: It is hygroscopic at humidity above 65%.
Sorbitol
EXCIPIENTS IN TABLETS FORMULATION
Advantage of Sucrose:
They are all used for direct compression.
EXCIPIENTS IN TABLETS FORMULATION
Disadvantage of Sucrose:
Hygroscopic when exposed to
elevated humidity.
EXCIPIENTS IN TABLETS FORMULATION
Trade Name: Avicel – a direct compression material
Microcrystalline cellulose (MCC)
EXCIPIENTS IN TABLETS FORMULATION
Two Grades available of MCC
- PH 101 powder
- PH 102 granules
EXCIPIENTS IN TABLETS FORMULATION
Advantage of Microcrystalline cellulose (MCC):
Acts as a diluent and disintegrating agents.
EXCIPIENTS IN TABLETS FORMULATION
Used to impart cohesive qualities
to the powdered material
Binders and Adhesive
EXCIPIENTS IN TABLETS FORMULATION
Characteristics of Binders:
Used in dry form in the powder and then moistened with a solvent
Method I
EXCIPIENTS IN TABLETS FORMULATION
Characteristics of Binders:
Often added in solution form
Method II
EXCIPIENTS IN TABLETS FORMULATION
Characteristics of Binders:
MCC, microcrystalline dextrose,
amylose, and PVP are utilized in the direct compression technique.
Method III
EXCIPIENTS IN TABLETS FORMULATION
Corn starch is often used in the concentration of 10–20%
Starch paste
EXCIPIENTS IN TABLETS FORMULATION
Concentration 10–20% aqueous solution. Prepared freshly and added in warm condition
Gelatin Solution
EXCIPIENTS IN TABLETS FORMULATION
Cellulosic Solutions: (3)
- HPMC (Hydroxy propyl methyl cellulose)
- HEC (Hydroxy ethyl cellulose), HPC (Hydroxy propyl cellulose)
- PVP (Polyvinylpyrrolidone)
EXCIPIENTS IN TABLETS FORMULATION
A substance to a mixture of substances, added to tablet to facilitate its breakup or disintegration after administration in the GIT.
Disintegrants
EXCIPIENTS IN TABLETS FORMULATION
Disintegrants can be classified chemically: (6)
Starches, clays, celluloses, alginates, gums and cross-linked polymers.
EXCIPIENTS IN TABLETS FORMULATION
Superdisintegrants: (3)
- Croscarmellose
- Crospovidone
- Sodium starch glycolate
EXCIPIENTS IN TABLETS FORMULATION
Cross linked cellulose
Croscarmellose
EXCIPIENTS IN TABLETS FORMULATION
Cross linked polyvinyl pyrrolidone
Crospovidone
EXCIPIENTS IN TABLETS FORMULATION
Cross linked starch
Sodium Starch Glycolate
EXCIPIENTS IN TABLETS FORMULATION
Used for reducing the sticking or adhesion of any of the tablet.
Antiadherents
EXCIPIENTS IN TABLETS FORMULATION
Colorants are obtained in two forms dyes and lakes.
Coloring Agents
EXCIPIENTS IN TABLETS FORMULATION
Types of Coloring Agents: (2)
- Dyes
- Color lakes
EXCIPIENTS IN TABLETS FORMULATION
Are dissolved in the binding solution prior to the granulating process.
Dyes
EXCIPIENTS IN TABLETS FORMULATION
Are dyes which are adsorbed onto a hydrous oxide of a heavy metal.
Color Lakes
EXCIPIENTS IN TABLETS FORMULATION
Flavors are usually limited to chewable tablets or other tablets intended to dissolve in the mouth. The use of sweeteners is primarily limited to chewable tablets. E.g. Sugar
Flavors and Sweeteners
EXCIPIENTS IN TABLETS FORMULATION
Artificial sweetener, 500 times sweeter than sucrose
Disadvantages
(i) It has a bitter after taste and
(ii) carcinogenic
Saccharin
EXCIPIENTS IN TABLETS FORMULATION
72% as sweet as sugar, cooling & mouth filling effect
Mannitol
EXCIPIENTS IN TABLETS FORMULATION
Either alone or with saccharin – it is banned
Cyclamate
EXCIPIENTS IN TABLETS FORMULATION
Widely replacing saccharin
Disadvantage – lack of stability in presence of moisture
Aspartame (Searle)
Different solid or powder ingredients are reduced to the same particle size since
particles of different sizes will segregate while mixing
Tablet Manufacturing Process
TABLET MANUFACTURING PROCESS
The different solid or powder ingredients are reduced to the same particle size since particles of different sizes will segregate while mixing
Pulverization and Mixing
Types of Tablet Manufacturing Process: (4)
- Pulverization and Mixing
- Granulation
- Wet Granulation
- Dry Granulation
TABLET MANUFACTURING PROCESS
The process in which primary powder particles are made to adhere to form large multi-particle entities.
Granulation
TABLET MANUFACTURING PROCESS
The process in which formation of granules is done by adding a granulating liquid.
Wet Granulation
TABLET MANUFACTURING PROCESS
Manufacturing process directly
compresses powdered materials into tablets without modifying physical properties
Direct Compression
TABLET MANUFACTURING PROCESS
A process where no liquid component is used in the granule formation
Dry Granulation
TABLET MANUFACTURING PROCESS
The process where coating material is applied to the surface of the tablet to achieve the desired properties of dosage form over the uncoated variety.
Tablet Coating
TABLET MANUFACTURING PROCESS
Types of Tablet Coating: (7)
- Sugar Coating
- Film Coating
- Microencapsulation
- Press/Compression Coating
- Electrostatic Coating
- Laminated Coating
- Enteric Coating
Types of Packaging of Tablet
- Blister Package
- Strip Package
- Alu-Alu Package
- Bottle Packaging
MACHINES/EQUIPMENT USED IN TABLET PRODUCTION
Weighing Balance: (2)
- Bulk Weighing Balance (kg)
- Electronic Weighing Balance (g/mg)
MACHINES/EQUIPMENT USED IN TABLET PRODUCTION
Refers to the process of reducing the size of drugs into smaller particles or fine powder. It involves cutting or breaking particles of solids into smaller pieces.
Size reduction
MACHINES/EQUIPMENT USED IN TABLET PRODUCTION
Size Reduction Equipment: (4)
- Edge-Runner Mill
- End-Runner Mill
- Pin Mill
- Hammer Mill
MACHINES/EQUIPMENT USED IN TABLET PRODUCTION
Other Name: Chilean mill or Roller Stone mill
Consist of one or two heavy steel or granite
Produces fine particles
Edge-Runner Mill
MACHINES/EQUIPMENT USED IN TABLET PRODUCTION
Consist of a weighted pestle mounted eccentrically in a ceramic, granite or metal mortar
Produces moderately fine particles
End-Runner Mill
MACHINES/EQUIPMENT USED IN TABLET PRODUCTION
Fines: 40-100 mesh
Ideally for pulverizing materials
Has a wide production adaptability ranging from granular material to super fine particles
Pin Mill
MACHINES/EQUIPMENT USED IN TABLET PRODUCTION
Fines: 5mm-20 mesh
Uses a cutting knife and liner
Material are crushed by the impact and cut force
Hammer Mill
A wide range of mixing equipment is used in tablet manufacturing to mix powders and ingredients accurately.
Mixing Equipment
Examples of Mixing Equipment: (2)
- V-Blender
- Double-Cone Mixer
MIXING EQUIPMENT
Other name of V-Blender: (2)
Twin Shell blender, V cone blender
MIXING EQUIPMENT
V-Blender
Made up ___ that are welled together in a V- shape angle ranging ___ to ___
2 inclined cylinders;
75 degrees to 90 degrees
MIXING EQUIPMENT
V-Blender
Performs a ___ rotation.
360 degree
MIXING EQUIPMENT
V-Blender
Normal cycle duration range of ___ ; depending on the powder/granules being mixed.
15 minutes
MIXING EQUIPMENT
V-Blender
Most twin shell blenders come in a ___ construction
304 stainless steel
MIXING EQUIPMENT
V-Blender
Most Popular pieces of equipment used for ___ and best suit for ___ .
Tumble blending;
dry mixing
MIXING EQUIPMENT
Cause materials to cascade within a rotating vessel relying on the action of gravity. Work on a diffusion mechanism: solids are dispersed across the newly exposed surface as the vessel rotates about a horizontal axis.
V-Blender
MIXING EQUIPMENT
Consists of two cone-shaped sections welded at their bases to a central cylindrical section.
Double-Cone Mixer
MIXING EQUIPMENT
Useful for mixing dry powder and granules for tablets formulation. Performs mixing, uniform blending and deagglomeration functions.
Double-Cone Mixer
MIXING EQUIPMENT
Double-Cone Mixer
Normal cycle time is ___ and can be more or less depending upon the complexity of the material
being mixed.
10 minutes
MIXING EQUIPMENT
Produces a consistent mixture despite variations in the amount. Most often used for dry blending of free solids. The solids being blended in these blenders can vary in bulk density and percentage of the total mixture. The material being blended is constantly intermixed as the it rotates
Double Cone
MIXING EQUIPMENT
A process of producing granules generally. Granulation process implies the techniques that are used to combine powdered particles to form relatively bigger ones called granules. this process is used for production of tablets.
Granulation
MIXING EQUIPMENT
Used for wet and dry granulation. Reduction of material through shear with few attrition.
Oscillating Granulator
MIXING EQUIPMENT
Other name for Oscillating Granulator:
Rotary Granulator
MIXING EQUIPMENT
Is used for cutting and hammering of the substance. Easy to operate and can work on variable speed. Can be for wet and dry granulation
Multi Mill
Drying Equipment: (2)
- Tray Dryer Oven
- Fluidized Bed Dryer
DRYING EQUIPMENT
An enclosed insulated chamber in which trays are placed on top of each other. Heat transfer is done by circulation of hot air by electric heaters or any other heating media. Blower fans are
installed inside to ensure proper circulation and transfer of heat.
Tray Dryer Oven
DRYING EQUIPMENT
It is fast acting and rapidly removes moisture from powder
particles to a level that is acceptable for tablet formulation. Works on the fluidization principle. A high-pressure Hot air from the supply is passed through the perforated container containing wet granules. As the hot air passes through container granules start to suspend in the air to become dry (called a fluidized state), the
process is called fluidization.
Fluidized Bed Dryer
Tableting Compression Machines: (2)
- Single Punch / Single Station / Eccentric Presses
- Multi-Station / Rotary Presses
TABLETING COMPRESSION MACHINES
Used in small batch production and is the simplest machine for tablet manufacturing.
Single Punch or Eccentric Pressor Single Station Press
TABLETING COMPRESSION MACHINES
Single punch machine uses single set of station tooling ( ___ and ___ )
a die and a pair of upper and lower punches
TABLETING COMPRESSION MACHINES
The compaction force on the fill material is exerted by only the upper punch while the lower punch static such action equivalent to hammering motion and as a result, the single punch press is referred ___ .
stamping process
TABLETING COMPRESSION MACHINES
The single punch tablet press usually produces about ___ tablets/min.
60-85
TABLETING COMPRESSION MACHINES
It is used in large scale production unit.
Multi-Station / Rotary Presses
TABLETING COMPRESSION MACHINES
Multi-Station machine produces ___ tabs/min.
1,200
TABLETING COMPRESSION MACHINES
Multi-Station
There are ___ sets of dies & punches.
70
TABLETING COMPRESSION MACHINES
A ___ has a circular rotating head, carrying a number of punch & dies assembles. There is uniform filling of the die. In that compression of granules takes place as the upper & the lower punches pass between a pair of rollers
rotary tablet machine
Quality Control Equipment: (5)
- Disintegration Equipment (Tester)
- Tablet Hardiness Tester
- Tablet Friability Tester
- Dissolution Tester
- Tablet Thickness Tester
QUALITY CONTROL EQUIPMENT
A solid state instrument designed for the accurate estimation of disintegration time of tablets as per IP/USP standards. The instrument is designed to test two batches of six tablets, simultaneously. The unit is extremely useful for pharmaceutical industries.
Disintegration Tester
QUALITY CONTROL EQUIPMENT
More correctly known as diametral/diametrical crushing
strength. Designed to detect breaking strength of tablets. It tests hardness value of tablets with specific tablet diameter and specific hardness range.
Tablet Hardiness Tester
QUALITY CONTROL EQUIPMENT
Used to test the durability of tablets during packing processes and transit. This involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum with a baffle.
Tablet Friability Tester
QUALITY CONTROL EQUIPMENT
It measures the extent and rate of solution formation from a dosage
form, such as tablet. The ** of a drug is important for its bioavailability and therapeutic effectiveness. ** and drug release are terms used
interchangeably.
Dissolution Tester
QUALITY CONTROL EQUIPMENT
The test that is used to measure how thick the tablet is, known as the tablet thickness test. Ensure that tablet thickness is within a specified range
Tablet Thickness Tester
Coated and Polishing Machines for Coated Tablet: (2)
- Standard Coating Pan
- Perforated Coating Pan
COATING AND POLISHING MACHINES FOR COATED TABLET
Is a conventional type. Consisting of a circular metal pan tilted at an angle of 30-45 degrees on a stand.
Standard Coating Pan
Packaging Machines: (2)
- Blister Packaging Machine
- Strip Packing Machine
COATING AND POLISHING MACHINES FOR COATED TABLET
Equipment that has a fully or partially perforated drum. It rotates on the horizontal axis while the overall system remains enclosed. For the effective coating there is a spraying nozzle in the machine.
Perforated Coating Pan
PACKAGING MACHINES
Blister packaging is produced by a
thermoforming process. During the process, a plastic or aluminum foil sheet is heated and molded to form single or multiple bubbles or pockets known as blisters.
Blister Packaging Machine
PACKAGING MACHINES
Widely used equipment in pharmaceutical industries mostly to pack tablet capsules & pills in aluminum foil and make them safe & ready to distribute in the market.
Strip Packing Machine
Basic Problems: (4)
- Weight Variation
- Mechanical Strength Related
- Content Uniformity
- Visual Defects
VISUAL DEFFECTS
Tableting Process: (4)
- Capping
- Lamination
- Cracking
- Chipping
VISUAL DEFFECTS
Machine: (1)
Double Impression
Visual Defects: (3)
- Formulation Design
- Tableting Process
- Machine
VISUAL DEFFECTS
Formulation Design: (3)
- Sticking
- Picking
- Binding
Portion of the surface of the tablet is removed
CAUSE: Punch tips have engraving or embossing,
REMEDY: Lettering should be large as possible
Picking
Tablet materials adhering to the die wall
CAUSE: Excessive moisture
REMEDY: Further drying
Sticking
Partial or complete separation of the top or bottom of tablet
CAUSE: Air entrapment
REMEDY: Increasing the density of granules
Capping
Unequal distribution of color on a tablet,
CAUSE: improperly mixed dye
REMEDY: Proper mixing
Mottling
Separation of two or more distinct
layers
CAUSE: Air entrapment
REMEDY: Increasing the density of granules
Lamination
Quality Control Test for Tablets
- General Appearance
- Organoleptic Properties
- Weight Uniformity and Content Uniformity
- Dissolution Test
- Weight Variation, Thickness and Diameter
- Hardness and Friability