TABLETS
INTRODUCTION
Definition:
• Tablet is defined as a compressed unit solid doasge form containing
medicament with or without diluents.
• According to Idian Pharmacopoeia
Pharmaceutical tablets are solid, flat or biconvex discuss, unit dosage form,
prepared by compressing a drugs or a mixture of drugs, with or without
diluents.
• It is the most popular doasge form and 70% of the medicines are dispensed
in the form of tablets.
• They vary in shape and differ greatly in size and weight, depending on
amount of medicinal substances and the intended mode of administration.
Ideal characteristics of tablets
• A tablet must be strong and hard to withstand mechanical shock during
manufacturing, packing, shipping, dispensing and use.
• The drug content of the tablet must be bioavailable that is, the tablet must
be able to release its content in a predictable and reproducible manner.
• The tablet must be chemically and physically stable to maintain its
chemical and physical attributes during manufacture, storage, and use.
• The tablet should have elegant product identity which is free from any
tablet defects like Cracks, discolouration and contamination.
• Tablets must be uniform in weight and in drug content.
ADVANTAGES
From patients stand point:
1. They are easy to carry, easy to swallow
2. They are attractive and pleasing in appearance.
3. Unpleasant taste can be masked by sugar coating.
4. They do not require any measurement of dose.
5. Some of the tablets are divided into halves and quarters by drawing lines
during manufacturing to facilitate breakage whenever a fractional dose is
required.
From the standpoint of manufacturer:
1. An accurate amount of medicament, even if very small, can be incorporated.
2. Tablets provide best combined properties of chemical, mechanical and
microbiological stability of all the oral dosage forms.
3. Since they are generally produced on a large scale, therefore, their cost of
production is relatively low, hence economical.
4. They are in general the easiest and cheapest to package and ship among all oral
dosage forms.
5. Some specialized tablets may be prepared for modified release profile of the
drug.
6. Product identification is potentially the simplest and cheapest requiring no
additional processing steps when employing an embossed or monogrammed
punch face.
DISADVANTAGES
1. The amorphous drugs or those having low density are difficult to compress into a
tablet.
2. Hygroscopic drugs are not suitable candidates for compressed tablets.
3. Drugs having poor wetting properties, slow dissolution profile, and high optimal
gastrointestinal absorption are difficult to formulate as a tablet.
4. Drugs having a bitter taste and objectionable odour require special treatment like
coating or encapsulation which may increase their production cost.
5. Drugs sensitive to oxygen may require certain treatment like special coating as
well as packaging which may increase the overall manufacturing cost.
6. High dose drugs are difficult to formulate as tablets.
7. Some drugs which get absorbed from the upper part of GIT may cause
bioavailability problem in tablet dosage form.
8. Liquid drugs are difficult to formulate as a tablet.
9. Swallowing of tablets, especially by children and critically ill patients is very
difficult.
TYPES OF TABLETS
(a) Tablets ingested orally
(b) Tablets used in the oral cavities
(c) Tablets administered by other routes
(d) Tablets used to prepare solutions
(a) Tablets ingested orally
• Compressed tablets
• Multiple compressed tablets
Layered tablet
Compression coated tablets
Inlay tablets
• Modified release tablets
Controlled release tablets
Sustained release tablets
• Delayed / Enteric coated tablets
• Sugar coated tablets
• Film coated tablets
• Gelatin coated tablets
• Chewable tablets
(b) Tablets used in the oral cavities
• Buccal Tablets
• Sublingual tablets
• Troches and Lozenges
• Dental cones
(c) Tablets administered by other routes
• Implantation tablets
• Vaginal tablets
(d) Tablets used to prepare solutions
• Effervescent tablets
• Dispensing tablets
• Hypodermic tablets
• Tablet triturates
Compressed tablets
• It represent a significant proportion of tablets that are clinically used to provide
systemic administration of therapeutic agents either in an uncoated state (i.e., in
their simplest form).
• These tablets are designed to provide rapid disintegration in the gastric fluid
following ingestion hence, allowing rapid release of the drug and, ultimately,
systemic absorption of the dosage form.
• Compressed tablets are formed by compression of powdered, crystalline, or
granular materials into the required geometry by the application of high
pressures, utilizing steel punches and die.
• In addition to the Active Pharmaceutical Ingredient(s) (APIs), compressed
tablets usually contain a number of pharmaceutical excipients e.g., bulking
agents, disintegrants, binders, lubricants, controlled-release polymers and other
miscellaneous adjuncts such as colourants and flavourants which serve different
and specialized purpose during tablet manufacture, storage, and use.
• Examples of compressed tablets include tablets for oral, buccal, sublingual, or
vaginal administration.
Multiple compressed tablets / Layered tablets
• These tablets are composed of two or more layers.
• These are compressed tablets made by more than one compression cycle.
• Such tablets are prepared by compressing additional tablet granulation on a
previously compressed granulation.
• The operation may be repeated to produce multilayered tablets of two or three
layers.
• The result may be multiple layer tablet or a tablet within a tablet, the inner tablet
being the core and the outer portion being the shell.
• This process is best used when separation of active ingredients is needed for
stability purpose.
• These tablets also used when there is need to mask the bitter taste of a drug.
Layered tablet
• They are tablets composed of two or more layers of ingredients.
• Layered tablets are prepared by compressing additional tablet granulation on a
previously compressed granulation to form two-layered or three-layered tablets,
depending on the number of separate fills.
• Each layer may contain a different medicinal agent, separated for reasons of
physical or chemical incompatibility, staged drug release, or simply the unique
appearance of the layered tablet.
• Unlike conventional tablets where we have a single piece of substance moulded
to shape, layered tablets have the appearance of a sandwich because the edges of
each layer are exposed.
Compression coated tablets
• It also referred to as dry-coated tablets or press-coated tablets, are tablets with
two parts; internal core and surrounding coat.
• Hence tablets are prepared by feeding previously compressed tablets into a
special tablet press (e.g., Manesty Drycota) and compressing another
granulation layer around a preformed tablet core.
• Compression coated tablets have all the advantages of compressed tablets (i.e.,
slotting, monogramming, speed of disintegration) while retaining the attributes
of sugarcoated tablets in masking the taste of the drug substance in the core
tablets.
• These tablets can also be used to separate incompatible drug substances (one in
the core and the other in the coat); in addition, they can provide a means of
giving an enteric coating to the core tablets.
Inlay tablets
• It also popularly known as dot, or bull’s-eye tablets are variation of compressed
tablets with a partially surrounded core. Instead of the tablet core being
completely surrounded by the coating, its top surface is completely exposed.
• Inlay tablets are prepared by feeding previously compressed tablets into a
prefilled die cavity of Stokes, Colton, or Kilian machines.
• When compressed, some of the coating material is displaced to form the sides.
• With a yellow core and a white coating, Inlay tablets resemble a fried egg.
• Inlay tablets can be useful in sustained-release preparations to reduce the size
and weight of the tablet.
• A typical example is a European preparation containing 25 mg of
hydrochlorothiazide in the bull’s-eye and 600 mg of potassium chloride in the
outside portion.
Modified release tablets
• These are the tablets which after oral administration release the drug at a desired
time and prolong the effect of the medicament.
• These tablets when taken orally release the medicament in a sufficient quantity
as and when required to maintain the maximum effective concentration of the
drug in the blood throughout the period of treatment.
• E.g. Diclofenac SR tablets.
Controlled release tablets
• Controlled release tablet is one which delivers the drug at a predetermined rate,
for locally or systemically, for a specified period of time.
• Continuous oral delivery of drugs at predictable and reproducible kinetic for
predetermined period throughout the course of GIT.
Sustained release tablets
• These tablets may provide an immediate dose required for the normal
therapeutic response, followed by the gradual release of drug in amounts
sufficient to maintain the therapeutic response for extended period of time
usually 8-12 hoirs.
Delayed / Enteric coated tablets
• Enteric-coated tablets are compressed tablets that have delayed-release
properties.
• They are coated with polymeric substances (such as cellulose acetate
phthalate/cellulose acetate butyrate; hydroxypropylmethylcellulose succinate;
and methacrylic acid copolymers) that resist solution in gastric fluid but
disintegrate and allow drug dissolution and absorption in the intestine.
• Enteric coatings are primarily employed when the drug substance is inactivated
or destroyed by gastric acid (e.g., erythromycin) or is particularly irritating to the
gastric mucosa (e.g., non-steroidal anti-inflammatory drugs) or when bypass of
the stomach substantially enhances drug absorption.
• Example: Lofnac 100 – Diclofenac sodium
delayed-release tablet USP 100mg
Sugar coated tablets
• These are compressed tablets that have been coated with concentrated sugar
solution to improve patient’s compliance, increase aesthetic appeal, mask
objectionable tastes or odours, increase stability and/or modify the release of
therapeutic agent(s).
• Sugarcoating was once quite common but lost commercial appeal due to the
time and expertise required in the coating process, the increase in size and
weight of coated tablets, high cost of process validation and shipping.
• Also, they permit separation of incompatible ingredients between coating and
core and this fact has been widely utilised in preparing many Multivitamin and
Multivitamin mineral combinations.
• Examples: Advil – Ibuprofen tablet BP 200mg.
Film-coated tablets
• These are conventional tablets coated with a thin layer of polymer (e.g.,
hydroxypropyl methylcellulose, hydroxypropyl cellulose) or a mixture of
polymers (e.g., Eudragit E100) capable of forming a skin-like film.
• The film is usually coloured and also impacts the same general characteristics as
sugar coating with the added advantage of being more durable, less bulky, and
less time-consuming to apply.
• By its composition, the coating is designed to break and expose the core tablet at
the desired location in the gastrointestinal tract.
• Coating compositions one or more polymers, which usually imcludes a plasticine
for the polymer and possibly a surfactant to facilitate spreading, in solution from
in a organic Solvent.
• After coating there is little increase in weight of tablet compared to compressed
tablets.
• They have less aesthetic appeal as compared to sugar coated tablets.
• Example: Curefenac 100 – Diclofenac potassium USP 100mg.
Gelatin-coated tablets
• These are compressed tablets coated with either one or two-toned colour gelatin.
• The gelatin coating impacts the same general characteristics as sugar coating and
film coating with the added advantage of improving the stability of
photosensitive APIs.
• The gelatin coating also facilitates swallowing, enables custom branding, and
prevents counterfeit since they are more tamper-evident than unsealed capsules.
• Gelatin-coated tablets are also ideal for double-blind clinical studies, or for drug
substances that can irritate the oesophagal mucosa when they are incorporated in
an immediate-release tablet such as bisphosphonates.
• Exampl: hydrochlorothiazide tablet.
Rapid-release tablets
• It is also called rapidly dissolving tablets, rapidly disintegrating tablets, orally-
dispersible tablets, quick disintegrating tablets, mouth dissolving tablets, fast
disintegrating tablets, fast-dissolving tablets, rapid-dissolving tablets, or porous
tablets are characterized by disintegrating or dissolving in the mouth within 1
minute, some within 10 seconds, leaving an easy-to-swallow residue.
• Tablets of this type are prepared using very water-soluble excipients designed to
wick water into the tablet for rapid disintegration or dissolution without
chewing.
• Rapid-release tablets offer increased convenience and ease of administration
with the potential to improve compliance, especially when swallowing
conventional solid oral-dosage forms presents difficulties for the patient.
• Disadvantages are difficulties associated with formulating rapid-release tablets,
including drug loading, taste masking, friability, manufacturing costs, and
stability of the product.
• Examples of rapid-release tablets include Clarinex Reditabs [desloratadine],
Schering.
Immediate-release tablets
• These tablets are designed to disintegrate and release their medication with no
special rate-controlling features, such as special coatings and other techniques.
• This is the most common type of tablet and examples include, chewable,
effervescent, sublingual and buccal tablets.
Chewable tablets
• These are big sized tablets which are difficult to swallow and thus, are chewed
within the buccal cavity prior to swallowing.
• They are especially useful for administration of large tablets to children and
adults who have difficulty swallowing conventional tablets or antacid
formulations in which the size of the tablet is normally large
• The neutralisation efficacy of the tablet is related to particle size within the
stomach.
• Chewable tablets are not conventionally used if the drug has issues regarding
taste acceptability.
• Example: Danacid – compound magnesium trisilicate tablet B.P.
Buccal and sublingual tablets
• These are small, flat, oval tablets that are intended to be dissolved in the buccal
pouch (buccal tablets) or beneath the tongue (sublingual tablets) for absorption
through the oral mucosa to produce a systemic effect.
• These tablets are employed to achieve either rapid absorption into the systemic
circulation e.g. glyceryl trinitrate sublingual tablets
• Alternatively, to enable oral absorption of drugs that are destroyed by the gastric
juice and/or are poorly absorbed from the gastrointestinal tract.
Lozenges
• Lozenges are solid preparations that contain one or more medicaments, usually
in a flavored, sweetened base, that are intended to dissolve or disintegrate slowly
in the mouth.
• They can be prepared by molding (gelatin and/or fused sucrose and sorbitol
base) or by compression of sugar-based tablets.
• Molded lozenges are sometimes referred to as pastilles, whereas compressed
lozenges may be referred to as troches.
• They are used for patients who cannot swallow solid oral dosage forms well as
for medications designed to be released slowly to yield a constant level of drug
in the oral cavity.
• Lozenges historically have been used for the relief of minor sore throat pain and
irritation and have been used extensively to deliver topical anesthetics and
antibacterial.
• Example: Vicks lozenges, Strepsils.
Dental cones
• These are compressed tablets meant for placement in the empty sockets after
tooth extraction.
• They prevent the multiplication of bacteria in the socket following such
extraction by using slow-releasing antibacterial compounds or to reduce bleeding
by containing the astringent.
• These tablets contain an excipient like lactose, sodium bicarbonate and sodium
chloride.
• These cones generally get dissolved in 20 to 40 minutes time.
Implantation Tablets/ Implants
• These are long-acting sterile tablets designed to provide continuous release of
drugs, often over a period of months or a year. They are placed subcutaneously
for systemic or local delivery.
• These may be made by heavy compression but are normally made by fusion.
The implants must be sterile and should be packed individually in sterile
condition.
• Implants are mainly used for the administration of hormones such as
testosterone steroids for contraception. They usually contain rate-controlling
excipients in addition to the active ingredient(s).
• Several types of implants are available including pellets, resorbable
microparticles, polymer implants, in situ–forming gel/solid implants,
metal/plastic implants, and drug-eluting stents.
• The disadvantages of implant tablets are their administration, changing rate of
release with change of surface area and possibility of tissue reactions.
• Example: Implanon – etonogestrel (Organon).
Vaginal Tablets/ Vaginal Inserts
• Vaginal tablets are uncoated, bullet-shaped, or ovoid tablets designed for vaginal
administration.
• They are prepared by compression and are shaped to fit tightly on plastic inserter
devices that accompany the product.
• Following insertion, retention and slow dissolution of the tablet occur, releasing
the medicaments to provide the local pharmacological effect (e.g. for the
treatment of bacterial or fungal infection).
• Vaginal tablets may also be used to provide systemic absorption of therapeutic
agents.
• Example: Gyno-Tiocosid (Neimeth), Gynesatum- Clotrimazole vaginal Tablet
Effervescent tablets
• These tablets are uncoated tablets that generally contain organic acids (such as
tartaric or citric acid) and sodium bicarbonate in addition to the medicinal
substance or API.
• They react rapidly in the presence of water by releasing carbon dioxide which
acts as a disintegrator to produce either a drug suspension or an aqueous
solution.
• These tablets are prepared by compressing granular effervescent salts (organic
acid and bicarbonate) with the medicinal substances.
• They have capability of producing clear solution, such tablets also produce
pealesently flavoured carbonated drink, which assist in masking the taste of
certain drugs.
• A typical example of this tablet type is Ca C1000 Sandoz effervescent tablet
(Novartis).
• The disadvantages of the effervescent tablet, is related to the difficulty of
producing a chemically stable product. Even the moisture in the air during
product preparation may be adequate to initiate effervescent reactivity.
• These tablets are specially packed in hemetic type foil pouches or are stack
packed in cylindrical tubes with minimal air space.
Dispensing tablets
• These tablets also referred to as compounding tablets are tablets supplied
primarily as a convenience for extemporaneous compounding.
• These tablets contain large amounts of highly potent APIs, and thus are used by a
pharmacist to compound prescriptions that can be incorporated readily into
powders and liquids, thus, circumventing the necessity to weigh small quantities
of these potent drug substances.
• Dispensing tablets are no longer in use and had the dangerous potential of being
inadvertently dispensed as such to patients.
• Examples include silver potentiate, bichloride of mercury merbromin and
quaternary ammonium compounds.
Hypodermic tablets
• Hypodermic tablets are soft, readily soluble tablets that were originally used by
physicians in extemporaneous preparation of parenteral solutions.
• These tablets are dissolved in a suitable vehicle (water for injections) and
administered by parenteral route.
• Hypodermic tablets are no longer used in most countries due to the difficulty in
achieving sterility.
• Also, the availability of stable parenteral solutions and prefabricated injectable
products, some in disposable syringes have also discouraged their use in recent
times.
• e.g., Dilaudid – Dihydromorphinone HCl (Bilhuber Knoll Corp.).
TABLET TRITURATES
• Tablet triturates are small, usually cylindrical, moulded, or compressed tablets
containing small amounts of usually potent drugs mixed with a combination of
sucrose and lactose or any suitable diluent.
• They are prepared from moist material, using a triturate mould that gives them
the shape of cut sections of a cylinder.
• Since tablet triturates must completely and rapidly dissolve in water, only a
minimal amount of pressure is applied during their manufacture.
• One of the problems encountered during the manufacture of this tablet type is
the failure to find a lubricant that is completely water-soluble.
• Example: Nitroglycerine tablets.
Ideal properties of excipients
1. They should be non-toxic and acceptable by regulatory agencies in all the
countries where the product is to be marketed.
2. They must be commercially available in an acceptable grade in all the countries
where the product is to be manufactured.
3. Their cost should be acceptably low.
4. They should be physiologically inert.
5. They should be physically and chemically stable by themselves and in
combination with the drugs and other tablet components.
6. They should be free of any unacceptable microbiologic load.
7. They should be compatible to colour (not producing any off-colour appearance).
8. If the drug product is also classified as food (e.g., certain vitamins products), the
diluents and other excipients used should be approved as food additives.
9. They should not affect the bioavailability of the added drugs.
Function of excipients
• Impart weight, accuracy, & volume.
• Improve solubility, Increase stability
• Enhance bioavailability
• Modifying drug release
• Assist product identification
• Increase patient acceptability
• Facilitate dosage form design
Different excipients are:
1. Diluent / Filler
2. Binder and adhesive
3. Disintegrants
4. Lubricants and glidants
5. Colouring agents
6. Flavoring agents
7. Sweetening agents
Formulation of a tablet
It requires the following considerations:
1. Size of dose or quantity of active ingredients
2. Stability of active ingredient(s)
3. Solubility of active ingredient(s)
4. Density of active ingredient(s)
5. Compressibility of active ingredient(s)
6. Selection of excipients
7. Method of granulation (preparation for compression)
8. Character of granulation
9. Tablet press, type, size, capacity
10. Environmental conditions (ambient or humidity control)
11. Stability of the final product
12. Bioavailability of the active drug content of the tablet
Spray Drying Granulation:
• Products like microcapsules, food ingredients, flavours, and various
biotechnological preparations can be produced by this process.
• In this process is a continuous process requiring solution or suspension (rather
than the initially dried primar y powder particles) to produce a dry granular
product.
• The solution or suspension may be a complete formulation, a drug alone, or a
mixture of different excipients. The dry powder continues to be produced
simultaneously along with the feeding of suspension to the drying system.
• The three fundamental steps involved in spray drying process are:
i) Fine droplets are produced by atomising the liquid feed.
ii) These spray droplets are mixed with a heated gas stream, resulting in the
evaporation of liquid leaving behind the dried solid particles.
iii) The dried powder is separated from the gas stream.
Advantages
i) Rapid and continuous process.
ii) Avoids labour intensive drying and granulation steps, thus, making it
more economical.
iii) OTC products are usually produced.
iv) Suitable for thermolabile substances.
Equipments used for wet granulation method
Littleford Lodige Mixer/Granulator
• high shear powder blening and nd wet massing within the same equipment.
• The unit is provided with a horizontal cylindrical shell fitted with plow-shaped
mixing tools arranged sequentially.
• One or more high-speed blending chopper assemblies are fixedbehind the
mixer.
• Sieving is no longer an essential requirement in powder blending because the
chopper blades result in uniform dispersion of powder lumps during dry
mixing.
• Injection tubes ending in one or more spray nozzles are required for adding
liquids.
• The chopper assembly is located immediately below the spray nozzles.
• 30 -60 seconds need to complete the mixing process.
• Continuation of dry blending process for 5 -10 minutes increases the
temperature up to 10 -15°C.
• The use of high -speed, high-shear mixer (Littleford Lodige type) for wet
granulation increases the wettability of powder mass which in turn increases the
power consumption by the mixer.
• The end point for wet granulation can be assessed from the readings appearing on
the ammeter or wattmeter mounted on the equipment.
Littleford MGT Mixer/Granulator
• During a production operation, the high shear solids mixer should be
mounted in a position that the bowl from a fluid bed dryer is placed under the mixer.
• This facilitates material transfer. Many fluid bed dryers ar e provided with wheel
assemblies to facilitate transfer of materials to and from the fluid bed unit.
• The advantage of raising the equipment to an appropriate working height is that
powder can be conveniently charged into the unit.
Diosna Mixer/Granulator
1) A bowl is mounted vertically with a high speed mixer blade . The blade revolves
around the bottom of the bowl. The blade fitted over a pin bar is powered by the
bottom of mixing bowl. The blade is constructed so as to prevent the material from
getting under it.
2) A high-speed chopper blade is also equipped within the mixer which breaks the
lumps and agglomerates.
3) A pneumatic discharge port provides the unit with an automatic discharge.
4) A lid is also present and a counterweight is employed to raise or lower the lid of a
larger mixer.
• The lid is provided with three openings:
i) First to accommodate a spray nozzle,
ii) A second larger opening for an air exhaust sleeve, and
iii) The third opening for a viewing port.
5) The end point of gran ulation operations can be determined by using ammeter
equipped on control panel of all the units.
The time sequences for operating Diosna mixer are:
1) Mixing for 2 minutes or less,
2) Granulating for 8 minutes or less, and
3) Discharge in 1 minute (when the pneumatic discharge system is in place and
capable of being predetermined).
Gral Mixer/Granulator
• A large mixing arm is configured in a round shape to accommodate the bowl and
provide large -scale mixing motion to the powder.
• A small chopper blade is located above the mixing arm and it enters off -centre from the
mixing arm.
• The mixing bowl is initially present at the floor level, however while being operated a
hydraulic bowl elevator cradle raises it to the mixing position.
Fluid Bed Spray Granulator
• The suction fan driven by an electric motor is moun ted at the top portion of the
unit providing necessary airflow for the fluidisation of powder.
• First the air is drawn through pre-filters to remove any impurity and then it is
heated to the desired temperature by the air heater .
• The material to be processed is placed in the material container present just
below the spray inlet.
• The liquid granulating agent is pumped from its container and then sprayed as a
fine mist onto the fluidised powder through a spray head .
• The particle -particle contact agglomerates the wetted par ticles.
• Dust and fine particles are retained by the exhaust filters present above the
product retainer.
• The spray operation is discontinued after appropriate agglomeration is achieved,
and the material is dried and discharged from the unit.
Advantages:
1. rapid wet massing, agglomeration, and drying within one unit. Generally, the
process gets completed within 60 -90 minutes or less, excluding the cleaning of
equipment.
Disadvantages
1) Powder components cannot be mixed properly through this system.
2) The processing of particles having uneven particle size or density may lead to
de-mixing.
3) The granulating agent present on the particle surface may stick to the equipment
filters, thus, reducing the effective surface area resulting in product loss and
increasing clean-up difficulties.
4) The flammable solvents or dry materials that may develop static charges may
cause dust explosion in a fluid bed dryer.
Double-Cone Mixer-Dryer
• Twin-shell blenders are modified to provide potential for proper orderly
arrangement of processes like powde mixing, wet massing, agglomeration, and
drying.
• Liquid feed leading to spray dispenser present just above the axis of rotation of
the unit.
• The same or the opposing trunnion provides a way for a vacuum inlet to a
vacuum intake port covered by nylon or other appropriate fine -filter sleeve.
• This is also located above the axis of rotation and out of the direct path of
powder motion.
• The blender utilises agitating elements capable of rotation within the powder
mass contained in the blender.
• A double wall constructionis provided within the blender to provide circulation
of a heating medium; while in other cases the systems are operated at room
temperature and vacuum pressure is the only source for liquid removal.
• The equipment and drying costs are very high in vacuum -drying operation.
• Drying time is also much longer than that of the fluid bed granulator processor.
However, the double -cone or twin-shell processors can be cleaned easily.
Day Nauta Mixer Processor
• which contains a screw assembly mounted in a conical chamber.
• The screw is utilised to lift the powder to be blended from the bottom to the top.
• For mixing the powder uniformly, th e screw assembly circles around the
conical chamber.
• The basic operations like incorporation of liquid -granulating agent, wet
massing, and drying (passing hot dry air through the wet ma terial) are involved
in powder mixing.
• The hot air is passed through the material (kept in a state of motion by the
orbiting screw material), dries the granules, and exits at the top of the processor.
Additional equipment like lump breaker (attached at the conical chamber
bottom), temperature monitor , nuclear, non-contact density gauge, ammeter or
wattmeter, infrared moisture analyser, and a sampling system are designed to
monitor and control process operation.
Topo Granulator
• Preparation of granules and coated particles under high vacuum.
• Dust-free suction process can be utilised to load materials to be granulated or
coated inside the chamber.
• Vacuum process is used to load the material in granulating compartment, while
the granulating fluid and other products (liquid or solid) are added by crushing
the added ingredients against the components already in the chamber.
• The granulating agents are added to the chamber under vacuum.
• This increases the granulation forces enough to create the necessary compaction.
• The agglomerated particles thus produced are dried within the chamber under
vacuum.
Slugging Process:
• Granulation by slugging is the process of compressing dry powder of
tablet formulation with tablet press having die cavity (large en ough in
diameter to fill quickly).
• The accuracy or condition of slug is not too important. Only sufficient
pressure to compact the powder into uniform slugs should be used.
• Once slugs are produced they are reduced to appropriate granule size
for final compression by screening and milling.
Factors which determine how well a material may slug are:
i) Compressibility or cohesiveness of the matter,
ii) Compression ratio of powder,
iii) Density of the powder,
iv) Machine type,
v) Punch and die size,
vi) Slug thickness,
vii) Speed of compression, and
viii) Pressure used to produce slug.
THANK YOU

TABLETS.pptx

  • 1.
  • 2.
    INTRODUCTION Definition: • Tablet isdefined as a compressed unit solid doasge form containing medicament with or without diluents. • According to Idian Pharmacopoeia Pharmaceutical tablets are solid, flat or biconvex discuss, unit dosage form, prepared by compressing a drugs or a mixture of drugs, with or without diluents. • It is the most popular doasge form and 70% of the medicines are dispensed in the form of tablets. • They vary in shape and differ greatly in size and weight, depending on amount of medicinal substances and the intended mode of administration.
  • 3.
    Ideal characteristics oftablets • A tablet must be strong and hard to withstand mechanical shock during manufacturing, packing, shipping, dispensing and use. • The drug content of the tablet must be bioavailable that is, the tablet must be able to release its content in a predictable and reproducible manner. • The tablet must be chemically and physically stable to maintain its chemical and physical attributes during manufacture, storage, and use. • The tablet should have elegant product identity which is free from any tablet defects like Cracks, discolouration and contamination. • Tablets must be uniform in weight and in drug content.
  • 4.
    ADVANTAGES From patients standpoint: 1. They are easy to carry, easy to swallow 2. They are attractive and pleasing in appearance. 3. Unpleasant taste can be masked by sugar coating. 4. They do not require any measurement of dose. 5. Some of the tablets are divided into halves and quarters by drawing lines during manufacturing to facilitate breakage whenever a fractional dose is required.
  • 5.
    From the standpointof manufacturer: 1. An accurate amount of medicament, even if very small, can be incorporated. 2. Tablets provide best combined properties of chemical, mechanical and microbiological stability of all the oral dosage forms. 3. Since they are generally produced on a large scale, therefore, their cost of production is relatively low, hence economical. 4. They are in general the easiest and cheapest to package and ship among all oral dosage forms. 5. Some specialized tablets may be prepared for modified release profile of the drug. 6. Product identification is potentially the simplest and cheapest requiring no additional processing steps when employing an embossed or monogrammed punch face.
  • 6.
    DISADVANTAGES 1. The amorphousdrugs or those having low density are difficult to compress into a tablet. 2. Hygroscopic drugs are not suitable candidates for compressed tablets. 3. Drugs having poor wetting properties, slow dissolution profile, and high optimal gastrointestinal absorption are difficult to formulate as a tablet. 4. Drugs having a bitter taste and objectionable odour require special treatment like coating or encapsulation which may increase their production cost. 5. Drugs sensitive to oxygen may require certain treatment like special coating as well as packaging which may increase the overall manufacturing cost. 6. High dose drugs are difficult to formulate as tablets. 7. Some drugs which get absorbed from the upper part of GIT may cause bioavailability problem in tablet dosage form. 8. Liquid drugs are difficult to formulate as a tablet. 9. Swallowing of tablets, especially by children and critically ill patients is very difficult.
  • 7.
    TYPES OF TABLETS (a)Tablets ingested orally (b) Tablets used in the oral cavities (c) Tablets administered by other routes (d) Tablets used to prepare solutions
  • 8.
    (a) Tablets ingestedorally • Compressed tablets • Multiple compressed tablets Layered tablet Compression coated tablets Inlay tablets • Modified release tablets Controlled release tablets Sustained release tablets • Delayed / Enteric coated tablets • Sugar coated tablets • Film coated tablets • Gelatin coated tablets • Chewable tablets
  • 9.
    (b) Tablets usedin the oral cavities • Buccal Tablets • Sublingual tablets • Troches and Lozenges • Dental cones (c) Tablets administered by other routes • Implantation tablets • Vaginal tablets (d) Tablets used to prepare solutions • Effervescent tablets • Dispensing tablets • Hypodermic tablets • Tablet triturates
  • 10.
    Compressed tablets • Itrepresent a significant proportion of tablets that are clinically used to provide systemic administration of therapeutic agents either in an uncoated state (i.e., in their simplest form). • These tablets are designed to provide rapid disintegration in the gastric fluid following ingestion hence, allowing rapid release of the drug and, ultimately, systemic absorption of the dosage form. • Compressed tablets are formed by compression of powdered, crystalline, or granular materials into the required geometry by the application of high pressures, utilizing steel punches and die.
  • 11.
    • In additionto the Active Pharmaceutical Ingredient(s) (APIs), compressed tablets usually contain a number of pharmaceutical excipients e.g., bulking agents, disintegrants, binders, lubricants, controlled-release polymers and other miscellaneous adjuncts such as colourants and flavourants which serve different and specialized purpose during tablet manufacture, storage, and use. • Examples of compressed tablets include tablets for oral, buccal, sublingual, or vaginal administration.
  • 12.
    Multiple compressed tablets/ Layered tablets • These tablets are composed of two or more layers. • These are compressed tablets made by more than one compression cycle. • Such tablets are prepared by compressing additional tablet granulation on a previously compressed granulation. • The operation may be repeated to produce multilayered tablets of two or three layers. • The result may be multiple layer tablet or a tablet within a tablet, the inner tablet being the core and the outer portion being the shell. • This process is best used when separation of active ingredients is needed for stability purpose. • These tablets also used when there is need to mask the bitter taste of a drug.
  • 13.
    Layered tablet • Theyare tablets composed of two or more layers of ingredients. • Layered tablets are prepared by compressing additional tablet granulation on a previously compressed granulation to form two-layered or three-layered tablets, depending on the number of separate fills. • Each layer may contain a different medicinal agent, separated for reasons of physical or chemical incompatibility, staged drug release, or simply the unique appearance of the layered tablet. • Unlike conventional tablets where we have a single piece of substance moulded to shape, layered tablets have the appearance of a sandwich because the edges of each layer are exposed.
  • 14.
    Compression coated tablets •It also referred to as dry-coated tablets or press-coated tablets, are tablets with two parts; internal core and surrounding coat. • Hence tablets are prepared by feeding previously compressed tablets into a special tablet press (e.g., Manesty Drycota) and compressing another granulation layer around a preformed tablet core. • Compression coated tablets have all the advantages of compressed tablets (i.e., slotting, monogramming, speed of disintegration) while retaining the attributes of sugarcoated tablets in masking the taste of the drug substance in the core tablets. • These tablets can also be used to separate incompatible drug substances (one in the core and the other in the coat); in addition, they can provide a means of giving an enteric coating to the core tablets.
  • 15.
    Inlay tablets • Italso popularly known as dot, or bull’s-eye tablets are variation of compressed tablets with a partially surrounded core. Instead of the tablet core being completely surrounded by the coating, its top surface is completely exposed. • Inlay tablets are prepared by feeding previously compressed tablets into a prefilled die cavity of Stokes, Colton, or Kilian machines. • When compressed, some of the coating material is displaced to form the sides. • With a yellow core and a white coating, Inlay tablets resemble a fried egg. • Inlay tablets can be useful in sustained-release preparations to reduce the size and weight of the tablet. • A typical example is a European preparation containing 25 mg of hydrochlorothiazide in the bull’s-eye and 600 mg of potassium chloride in the outside portion.
  • 16.
    Modified release tablets •These are the tablets which after oral administration release the drug at a desired time and prolong the effect of the medicament. • These tablets when taken orally release the medicament in a sufficient quantity as and when required to maintain the maximum effective concentration of the drug in the blood throughout the period of treatment. • E.g. Diclofenac SR tablets.
  • 17.
    Controlled release tablets •Controlled release tablet is one which delivers the drug at a predetermined rate, for locally or systemically, for a specified period of time. • Continuous oral delivery of drugs at predictable and reproducible kinetic for predetermined period throughout the course of GIT. Sustained release tablets • These tablets may provide an immediate dose required for the normal therapeutic response, followed by the gradual release of drug in amounts sufficient to maintain the therapeutic response for extended period of time usually 8-12 hoirs.
  • 18.
    Delayed / Entericcoated tablets • Enteric-coated tablets are compressed tablets that have delayed-release properties. • They are coated with polymeric substances (such as cellulose acetate phthalate/cellulose acetate butyrate; hydroxypropylmethylcellulose succinate; and methacrylic acid copolymers) that resist solution in gastric fluid but disintegrate and allow drug dissolution and absorption in the intestine. • Enteric coatings are primarily employed when the drug substance is inactivated or destroyed by gastric acid (e.g., erythromycin) or is particularly irritating to the gastric mucosa (e.g., non-steroidal anti-inflammatory drugs) or when bypass of the stomach substantially enhances drug absorption. • Example: Lofnac 100 – Diclofenac sodium delayed-release tablet USP 100mg
  • 19.
    Sugar coated tablets •These are compressed tablets that have been coated with concentrated sugar solution to improve patient’s compliance, increase aesthetic appeal, mask objectionable tastes or odours, increase stability and/or modify the release of therapeutic agent(s). • Sugarcoating was once quite common but lost commercial appeal due to the time and expertise required in the coating process, the increase in size and weight of coated tablets, high cost of process validation and shipping. • Also, they permit separation of incompatible ingredients between coating and core and this fact has been widely utilised in preparing many Multivitamin and Multivitamin mineral combinations. • Examples: Advil – Ibuprofen tablet BP 200mg.
  • 20.
    Film-coated tablets • Theseare conventional tablets coated with a thin layer of polymer (e.g., hydroxypropyl methylcellulose, hydroxypropyl cellulose) or a mixture of polymers (e.g., Eudragit E100) capable of forming a skin-like film. • The film is usually coloured and also impacts the same general characteristics as sugar coating with the added advantage of being more durable, less bulky, and less time-consuming to apply. • By its composition, the coating is designed to break and expose the core tablet at the desired location in the gastrointestinal tract. • Coating compositions one or more polymers, which usually imcludes a plasticine for the polymer and possibly a surfactant to facilitate spreading, in solution from in a organic Solvent.
  • 21.
    • After coatingthere is little increase in weight of tablet compared to compressed tablets. • They have less aesthetic appeal as compared to sugar coated tablets. • Example: Curefenac 100 – Diclofenac potassium USP 100mg.
  • 22.
    Gelatin-coated tablets • Theseare compressed tablets coated with either one or two-toned colour gelatin. • The gelatin coating impacts the same general characteristics as sugar coating and film coating with the added advantage of improving the stability of photosensitive APIs. • The gelatin coating also facilitates swallowing, enables custom branding, and prevents counterfeit since they are more tamper-evident than unsealed capsules. • Gelatin-coated tablets are also ideal for double-blind clinical studies, or for drug substances that can irritate the oesophagal mucosa when they are incorporated in an immediate-release tablet such as bisphosphonates. • Exampl: hydrochlorothiazide tablet.
  • 23.
    Rapid-release tablets • Itis also called rapidly dissolving tablets, rapidly disintegrating tablets, orally- dispersible tablets, quick disintegrating tablets, mouth dissolving tablets, fast disintegrating tablets, fast-dissolving tablets, rapid-dissolving tablets, or porous tablets are characterized by disintegrating or dissolving in the mouth within 1 minute, some within 10 seconds, leaving an easy-to-swallow residue. • Tablets of this type are prepared using very water-soluble excipients designed to wick water into the tablet for rapid disintegration or dissolution without chewing. • Rapid-release tablets offer increased convenience and ease of administration with the potential to improve compliance, especially when swallowing conventional solid oral-dosage forms presents difficulties for the patient.
  • 24.
    • Disadvantages aredifficulties associated with formulating rapid-release tablets, including drug loading, taste masking, friability, manufacturing costs, and stability of the product. • Examples of rapid-release tablets include Clarinex Reditabs [desloratadine], Schering.
  • 25.
    Immediate-release tablets • Thesetablets are designed to disintegrate and release their medication with no special rate-controlling features, such as special coatings and other techniques. • This is the most common type of tablet and examples include, chewable, effervescent, sublingual and buccal tablets.
  • 26.
    Chewable tablets • Theseare big sized tablets which are difficult to swallow and thus, are chewed within the buccal cavity prior to swallowing. • They are especially useful for administration of large tablets to children and adults who have difficulty swallowing conventional tablets or antacid formulations in which the size of the tablet is normally large • The neutralisation efficacy of the tablet is related to particle size within the stomach. • Chewable tablets are not conventionally used if the drug has issues regarding taste acceptability. • Example: Danacid – compound magnesium trisilicate tablet B.P.
  • 27.
    Buccal and sublingualtablets • These are small, flat, oval tablets that are intended to be dissolved in the buccal pouch (buccal tablets) or beneath the tongue (sublingual tablets) for absorption through the oral mucosa to produce a systemic effect. • These tablets are employed to achieve either rapid absorption into the systemic circulation e.g. glyceryl trinitrate sublingual tablets • Alternatively, to enable oral absorption of drugs that are destroyed by the gastric juice and/or are poorly absorbed from the gastrointestinal tract.
  • 28.
    Lozenges • Lozenges aresolid preparations that contain one or more medicaments, usually in a flavored, sweetened base, that are intended to dissolve or disintegrate slowly in the mouth. • They can be prepared by molding (gelatin and/or fused sucrose and sorbitol base) or by compression of sugar-based tablets. • Molded lozenges are sometimes referred to as pastilles, whereas compressed lozenges may be referred to as troches. • They are used for patients who cannot swallow solid oral dosage forms well as for medications designed to be released slowly to yield a constant level of drug in the oral cavity. • Lozenges historically have been used for the relief of minor sore throat pain and irritation and have been used extensively to deliver topical anesthetics and antibacterial. • Example: Vicks lozenges, Strepsils.
  • 29.
    Dental cones • Theseare compressed tablets meant for placement in the empty sockets after tooth extraction. • They prevent the multiplication of bacteria in the socket following such extraction by using slow-releasing antibacterial compounds or to reduce bleeding by containing the astringent. • These tablets contain an excipient like lactose, sodium bicarbonate and sodium chloride. • These cones generally get dissolved in 20 to 40 minutes time.
  • 30.
    Implantation Tablets/ Implants •These are long-acting sterile tablets designed to provide continuous release of drugs, often over a period of months or a year. They are placed subcutaneously for systemic or local delivery. • These may be made by heavy compression but are normally made by fusion. The implants must be sterile and should be packed individually in sterile condition. • Implants are mainly used for the administration of hormones such as testosterone steroids for contraception. They usually contain rate-controlling excipients in addition to the active ingredient(s). • Several types of implants are available including pellets, resorbable microparticles, polymer implants, in situ–forming gel/solid implants, metal/plastic implants, and drug-eluting stents.
  • 31.
    • The disadvantagesof implant tablets are their administration, changing rate of release with change of surface area and possibility of tissue reactions. • Example: Implanon – etonogestrel (Organon).
  • 32.
    Vaginal Tablets/ VaginalInserts • Vaginal tablets are uncoated, bullet-shaped, or ovoid tablets designed for vaginal administration. • They are prepared by compression and are shaped to fit tightly on plastic inserter devices that accompany the product. • Following insertion, retention and slow dissolution of the tablet occur, releasing the medicaments to provide the local pharmacological effect (e.g. for the treatment of bacterial or fungal infection). • Vaginal tablets may also be used to provide systemic absorption of therapeutic agents. • Example: Gyno-Tiocosid (Neimeth), Gynesatum- Clotrimazole vaginal Tablet
  • 33.
    Effervescent tablets • Thesetablets are uncoated tablets that generally contain organic acids (such as tartaric or citric acid) and sodium bicarbonate in addition to the medicinal substance or API. • They react rapidly in the presence of water by releasing carbon dioxide which acts as a disintegrator to produce either a drug suspension or an aqueous solution. • These tablets are prepared by compressing granular effervescent salts (organic acid and bicarbonate) with the medicinal substances. • They have capability of producing clear solution, such tablets also produce pealesently flavoured carbonated drink, which assist in masking the taste of certain drugs. • A typical example of this tablet type is Ca C1000 Sandoz effervescent tablet (Novartis).
  • 34.
    • The disadvantagesof the effervescent tablet, is related to the difficulty of producing a chemically stable product. Even the moisture in the air during product preparation may be adequate to initiate effervescent reactivity. • These tablets are specially packed in hemetic type foil pouches or are stack packed in cylindrical tubes with minimal air space.
  • 35.
    Dispensing tablets • Thesetablets also referred to as compounding tablets are tablets supplied primarily as a convenience for extemporaneous compounding. • These tablets contain large amounts of highly potent APIs, and thus are used by a pharmacist to compound prescriptions that can be incorporated readily into powders and liquids, thus, circumventing the necessity to weigh small quantities of these potent drug substances. • Dispensing tablets are no longer in use and had the dangerous potential of being inadvertently dispensed as such to patients. • Examples include silver potentiate, bichloride of mercury merbromin and quaternary ammonium compounds.
  • 36.
    Hypodermic tablets • Hypodermictablets are soft, readily soluble tablets that were originally used by physicians in extemporaneous preparation of parenteral solutions. • These tablets are dissolved in a suitable vehicle (water for injections) and administered by parenteral route. • Hypodermic tablets are no longer used in most countries due to the difficulty in achieving sterility. • Also, the availability of stable parenteral solutions and prefabricated injectable products, some in disposable syringes have also discouraged their use in recent times. • e.g., Dilaudid – Dihydromorphinone HCl (Bilhuber Knoll Corp.).
  • 37.
    TABLET TRITURATES • Tablettriturates are small, usually cylindrical, moulded, or compressed tablets containing small amounts of usually potent drugs mixed with a combination of sucrose and lactose or any suitable diluent. • They are prepared from moist material, using a triturate mould that gives them the shape of cut sections of a cylinder. • Since tablet triturates must completely and rapidly dissolve in water, only a minimal amount of pressure is applied during their manufacture. • One of the problems encountered during the manufacture of this tablet type is the failure to find a lubricant that is completely water-soluble. • Example: Nitroglycerine tablets.
  • 39.
    Ideal properties ofexcipients 1. They should be non-toxic and acceptable by regulatory agencies in all the countries where the product is to be marketed. 2. They must be commercially available in an acceptable grade in all the countries where the product is to be manufactured. 3. Their cost should be acceptably low. 4. They should be physiologically inert. 5. They should be physically and chemically stable by themselves and in combination with the drugs and other tablet components. 6. They should be free of any unacceptable microbiologic load. 7. They should be compatible to colour (not producing any off-colour appearance). 8. If the drug product is also classified as food (e.g., certain vitamins products), the diluents and other excipients used should be approved as food additives. 9. They should not affect the bioavailability of the added drugs.
  • 40.
    Function of excipients •Impart weight, accuracy, & volume. • Improve solubility, Increase stability • Enhance bioavailability • Modifying drug release • Assist product identification • Increase patient acceptability • Facilitate dosage form design
  • 41.
    Different excipients are: 1.Diluent / Filler 2. Binder and adhesive 3. Disintegrants 4. Lubricants and glidants 5. Colouring agents 6. Flavoring agents 7. Sweetening agents
  • 62.
    Formulation of atablet It requires the following considerations: 1. Size of dose or quantity of active ingredients 2. Stability of active ingredient(s) 3. Solubility of active ingredient(s) 4. Density of active ingredient(s) 5. Compressibility of active ingredient(s) 6. Selection of excipients 7. Method of granulation (preparation for compression) 8. Character of granulation 9. Tablet press, type, size, capacity 10. Environmental conditions (ambient or humidity control) 11. Stability of the final product 12. Bioavailability of the active drug content of the tablet
  • 82.
    Spray Drying Granulation: •Products like microcapsules, food ingredients, flavours, and various biotechnological preparations can be produced by this process. • In this process is a continuous process requiring solution or suspension (rather than the initially dried primar y powder particles) to produce a dry granular product. • The solution or suspension may be a complete formulation, a drug alone, or a mixture of different excipients. The dry powder continues to be produced simultaneously along with the feeding of suspension to the drying system. • The three fundamental steps involved in spray drying process are: i) Fine droplets are produced by atomising the liquid feed. ii) These spray droplets are mixed with a heated gas stream, resulting in the evaporation of liquid leaving behind the dried solid particles. iii) The dried powder is separated from the gas stream.
  • 83.
    Advantages i) Rapid andcontinuous process. ii) Avoids labour intensive drying and granulation steps, thus, making it more economical. iii) OTC products are usually produced. iv) Suitable for thermolabile substances.
  • 85.
    Equipments used forwet granulation method
  • 86.
    Littleford Lodige Mixer/Granulator •high shear powder blening and nd wet massing within the same equipment. • The unit is provided with a horizontal cylindrical shell fitted with plow-shaped mixing tools arranged sequentially. • One or more high-speed blending chopper assemblies are fixedbehind the mixer. • Sieving is no longer an essential requirement in powder blending because the chopper blades result in uniform dispersion of powder lumps during dry mixing. • Injection tubes ending in one or more spray nozzles are required for adding liquids. • The chopper assembly is located immediately below the spray nozzles. • 30 -60 seconds need to complete the mixing process. • Continuation of dry blending process for 5 -10 minutes increases the temperature up to 10 -15°C.
  • 87.
    • The useof high -speed, high-shear mixer (Littleford Lodige type) for wet granulation increases the wettability of powder mass which in turn increases the power consumption by the mixer. • The end point for wet granulation can be assessed from the readings appearing on the ammeter or wattmeter mounted on the equipment.
  • 88.
    Littleford MGT Mixer/Granulator •During a production operation, the high shear solids mixer should be mounted in a position that the bowl from a fluid bed dryer is placed under the mixer. • This facilitates material transfer. Many fluid bed dryers ar e provided with wheel assemblies to facilitate transfer of materials to and from the fluid bed unit. • The advantage of raising the equipment to an appropriate working height is that powder can be conveniently charged into the unit.
  • 89.
    Diosna Mixer/Granulator 1) Abowl is mounted vertically with a high speed mixer blade . The blade revolves around the bottom of the bowl. The blade fitted over a pin bar is powered by the bottom of mixing bowl. The blade is constructed so as to prevent the material from getting under it. 2) A high-speed chopper blade is also equipped within the mixer which breaks the lumps and agglomerates. 3) A pneumatic discharge port provides the unit with an automatic discharge. 4) A lid is also present and a counterweight is employed to raise or lower the lid of a larger mixer. • The lid is provided with three openings: i) First to accommodate a spray nozzle, ii) A second larger opening for an air exhaust sleeve, and iii) The third opening for a viewing port. 5) The end point of gran ulation operations can be determined by using ammeter equipped on control panel of all the units.
  • 90.
    The time sequencesfor operating Diosna mixer are: 1) Mixing for 2 minutes or less, 2) Granulating for 8 minutes or less, and 3) Discharge in 1 minute (when the pneumatic discharge system is in place and capable of being predetermined).
  • 91.
    Gral Mixer/Granulator • Alarge mixing arm is configured in a round shape to accommodate the bowl and provide large -scale mixing motion to the powder. • A small chopper blade is located above the mixing arm and it enters off -centre from the mixing arm. • The mixing bowl is initially present at the floor level, however while being operated a hydraulic bowl elevator cradle raises it to the mixing position.
  • 92.
    Fluid Bed SprayGranulator • The suction fan driven by an electric motor is moun ted at the top portion of the unit providing necessary airflow for the fluidisation of powder. • First the air is drawn through pre-filters to remove any impurity and then it is heated to the desired temperature by the air heater . • The material to be processed is placed in the material container present just below the spray inlet. • The liquid granulating agent is pumped from its container and then sprayed as a fine mist onto the fluidised powder through a spray head . • The particle -particle contact agglomerates the wetted par ticles. • Dust and fine particles are retained by the exhaust filters present above the product retainer. • The spray operation is discontinued after appropriate agglomeration is achieved, and the material is dried and discharged from the unit.
  • 95.
    Advantages: 1. rapid wetmassing, agglomeration, and drying within one unit. Generally, the process gets completed within 60 -90 minutes or less, excluding the cleaning of equipment. Disadvantages 1) Powder components cannot be mixed properly through this system. 2) The processing of particles having uneven particle size or density may lead to de-mixing. 3) The granulating agent present on the particle surface may stick to the equipment filters, thus, reducing the effective surface area resulting in product loss and increasing clean-up difficulties. 4) The flammable solvents or dry materials that may develop static charges may cause dust explosion in a fluid bed dryer.
  • 96.
    Double-Cone Mixer-Dryer • Twin-shellblenders are modified to provide potential for proper orderly arrangement of processes like powde mixing, wet massing, agglomeration, and drying. • Liquid feed leading to spray dispenser present just above the axis of rotation of the unit. • The same or the opposing trunnion provides a way for a vacuum inlet to a vacuum intake port covered by nylon or other appropriate fine -filter sleeve. • This is also located above the axis of rotation and out of the direct path of powder motion. • The blender utilises agitating elements capable of rotation within the powder mass contained in the blender. • A double wall constructionis provided within the blender to provide circulation of a heating medium; while in other cases the systems are operated at room temperature and vacuum pressure is the only source for liquid removal. • The equipment and drying costs are very high in vacuum -drying operation.
  • 97.
    • Drying timeis also much longer than that of the fluid bed granulator processor. However, the double -cone or twin-shell processors can be cleaned easily.
  • 98.
    Day Nauta MixerProcessor • which contains a screw assembly mounted in a conical chamber. • The screw is utilised to lift the powder to be blended from the bottom to the top. • For mixing the powder uniformly, th e screw assembly circles around the conical chamber. • The basic operations like incorporation of liquid -granulating agent, wet massing, and drying (passing hot dry air through the wet ma terial) are involved in powder mixing. • The hot air is passed through the material (kept in a state of motion by the orbiting screw material), dries the granules, and exits at the top of the processor. Additional equipment like lump breaker (attached at the conical chamber bottom), temperature monitor , nuclear, non-contact density gauge, ammeter or wattmeter, infrared moisture analyser, and a sampling system are designed to monitor and control process operation.
  • 100.
    Topo Granulator • Preparationof granules and coated particles under high vacuum. • Dust-free suction process can be utilised to load materials to be granulated or coated inside the chamber. • Vacuum process is used to load the material in granulating compartment, while the granulating fluid and other products (liquid or solid) are added by crushing the added ingredients against the components already in the chamber. • The granulating agents are added to the chamber under vacuum. • This increases the granulation forces enough to create the necessary compaction. • The agglomerated particles thus produced are dried within the chamber under vacuum.
  • 107.
    Slugging Process: • Granulationby slugging is the process of compressing dry powder of tablet formulation with tablet press having die cavity (large en ough in diameter to fill quickly). • The accuracy or condition of slug is not too important. Only sufficient pressure to compact the powder into uniform slugs should be used. • Once slugs are produced they are reduced to appropriate granule size for final compression by screening and milling.
  • 108.
    Factors which determinehow well a material may slug are: i) Compressibility or cohesiveness of the matter, ii) Compression ratio of powder, iii) Density of the powder, iv) Machine type, v) Punch and die size, vi) Slug thickness, vii) Speed of compression, and viii) Pressure used to produce slug.
  • 283.