Capsules and Tablets Flashcards by ANGELO KEANE CABIGON

___ together with ___ are the most
preferable dosage form when taken orally, as it is conveniently carried, readily identified and easily taken.

Capsules; tablets

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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.

How well did you know this?

Not at all

Perfectly

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.

How well did you know this?

Not at all

Perfectly

Main Types of Capsules

Hard Gelatin
Soft Gelatin

How well did you know this?

Not at all

Perfectly

The shells of the capsules may be composed of two pieces:

a body and a cap

How well did you know this?

Not at all

Perfectly

Two-piece capsules are commonly referred to as ___

hard-shell capsules

How well did you know this?

Not at all

Perfectly

One-piece capsules are often referred to as ___

soft-shell capsules

How well did you know this?

Not at all

Perfectly

Are used in most commercial medicated capsules.

Hard Gelatin

How well did you know this?

Not at all

Perfectly

The empty capsule shells
are made of ___ , ___ , and ___ . As such, they can be clear, colorless, and essentially tasteless

gelatin, sugar, and water

How well did you know this?

Not at all

Perfectly

Hard gelatin capsule shells are manufactured in two sections:

body and a shorter cap

How well did you know this?

Not at all

Perfectly

Made of gelatin to which
glycerin or a polyhydric alcohol such as sorbitol has been added.

Soft Gelatin Capsule

How well did you know this?

Not at all

Perfectly

Soft gelatin contain ___ moisture than hard capsules.

How well did you know this?

Not at all

Perfectly

Soft Gelatin capsules used to encapsulate and hermetically seal
___ , ___ , ___ , ___ , and even ___ .

liquids;
suspension;
pasty materials;
dry powders;
preformed tablets

How well did you know this?

Not at all

Perfectly

They are pharmaceutically elegant and are easily swallowed.

Soft Gelatin capsules

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

The printing stage includes all vital information, such as prescription recommendations, advertisements, and capsule branding.

Step 4: Printing and Packaging

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

A soft-gel shell is formed to contain and protect the fill material.

Step 1: Gelatin Preparation

How well did you know this?

Not at all

Perfectly

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.

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