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DIFFERENT DOSAGE FORMS
AND THEIR EVALUATION TECHNIQUES
Ashit Kumar Dutta
171142
Pharmacy Discipline,
Khulna University
Introduction to Dosage Forms
■ What is a dosage form?
– Dosage forms are pharmaceutical drug products in the form in which they are
marketed for use , with a specific mixture of active ingredients and inactive
components, in a particular configuration, and apportioned into a particular
dose.
– Examples: Tablets, capsules , syrups etc.
■ Why is a dosage form necessary?
– Accurate dose
– Protection of ingredients form external and internal damages (ex- gastric
acids)
– Controlling the release of medicaments
– Optimizing drug activity by letting drug reach the appropriate site of action
easily
– Patient compliance
Different Types of
Dosage Forms
■ Depending on the physical form
– Solid Dosage Forms
– Liquid Dosage Forms
– Gaseous Dosage Forms
■ Depending on route of administration
– Oral
– Topical
– Rectal
– Vaginal
– Parenteral (IV, IM, IC)
– Inhaled
– Ophthalmic
– Optic
Oral Dosage Forms
1. Tablets
■ Definition:
– A tablet is a hard, compressed medication
in round, oval or square shape .
– It mainly includes excipients such as
binders, disintegrates, coating materials,
sweeteners, disintegrates, glidants.
■ Subtypes of tablets:
– Compressed tablets (ex: paracetamol)
– Coated tablet (ex: riboflavin)
– Buccal or sublingual tablet (ex: nitroglycerin)
– Effervescent tablet (ex: disprin)
– Chewable tablet (ex: gestid – chewable antacid)
– Pastilles
– Dental cones (ex: dental mirror)
Coated tablets
■ Definition:
– A tablet coating is a covering over a tablet, used to mask the taste, make it easier to
swallow, or protect the active medication inside.
 Types of coating tablets:
o Enteric coated tablets: An enteric coating is a polymer barrier applied on oral medication that
prevents its dissolution or disintegration in the gastric environment.
Example: Erythromycin, Omeprazole
o Sugar coated tablets: In this type of tablets a layer of sugar is applied on top of the tablet. This is
done in order to mask the tablet from the bitter taste of the active ingredients. The sugar layer also
acts as a preservative to protect the tablet from microbial attacks.
Example: Advil – Ibuprofen
o Film coated tablets: A film coating is a thin polymer-based coat applied to a solid dosage form such
as a tablet
Example: Diclofenac Potassium USP
DIFFFERENT TYPES OF COATED TABLETS
SUGAR COATED TABLETS ENTERIC COATED TABLETS FILM COATED TABLETS
Compressed tablets:
■ A tablet prepared usually as a large-scale
production, by means of great pressure; most
compressed tablets consist of the active ingredient
and a diluent, binder, disintegrator and lubricant.
Example: Paracetamol tablet
Effervescent tablets:
■ Effervescent or carbon tablets are tablets
which are designed to dissolve in water,
and release carbon dioxide
Example: Disprin tablet (Asprin)
Buccal or sublingual
tablets:
Definition. Sublingual and buccal medications are administered
by placing them in the mouth, either under the tongue
(sublingual) or between the gum and the cheek (buccal). The
medications dissolve rapidly and are absorbed through the
mucous membranes of the mouth, where they enter into the
bloodstream.
Example: Nitroglycerin
Chewable tablets: Chewable tablets are big sized tablets which are difficult to
swallow and thus, are chewed within the buccal cavity prior to
swallowing.
Example: Magnesium trisilicate tablets
Dental cones:
A solid bounded by a circular base converging upon a
single vertex and intended for administration to the teeth
and gingiva in the oral cavity. This is cone with the
intention preventing microbial contamination and at the
same time keeping the teeth cavity in appropriate size.
Example: Dental Mirror
2. Capsule
■ What are capsules?
– Capsule is a medicine contained in a water-soluble gelatin shell.. The shell is
used to protect the API from degradation due to any gastric materials. There are
generally two types of capsules.
 Hard gelatin capsule
 Soft gelatin capsule
Ex: Doxicap (Doxicycline capsules)
3. Liquid Preparations
This medications are taken orally but they are physically
liquid.
■ Oral Syrups
– These are liquid preparations which are
concentrated solutions of sugar; mainly
sucrose.
 Example: Napa syrup (Paracetamol)
■ Oral Emulsions
– This is a suspension of droplets of two phases mixed
homogenously. In case of medical emulsions it is mainly
oil in water solution.
 Example: Liquid Paraffin
3. Liquid Preparations
(cont.)
■ Oral Suspension
– Oral suspensions are liquid solution where solid active
ingredients remain suspended inside the vehicle of the
container. This medication are needed to be shaken before
use other wise the medications will settle down and the
mixture will not be homogenous.
 Example: Phenytoin suspensions.
■ Gargles and mouth washes
– These are liquid preparations, mainly used to prevent oral
or throat infections.
 Example: Listerine mouth wash.
Topical Preparations
■ Ointments
– These are semi solid greasy preparations for application in skin , rectum, vagina or in
nasal mucosa.
 Example: Clobetasol Propionate ointment.
■ Creams
– These are semi solid emulsions which means a biphasic preparation. Oil in water or
water in oil
 Example: Clotrimazole cream.
■ Powders
– These are preparations of fine particles intended mainly for application on skin. They are
mainly used to prevent contamination or keep the wounded place dry to prevent microbial
growth
 Example: Nebanol powder (mixture of Neomycin sulphate and Bacitracin Zinc)
■ Pastes
– These are mainly ointments with a high concentration of fine solid particles.
 Example: 30% salicylic acid
Parenteral Preparations
Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for
injection or infusion, gels for injection and implants. They are sterile preparations intended to be administrated
directly into the systemic circulation in humans or animals.
■ Intra venous (IV)
– It is a liquid administered directly into the bloodstream via a vain. The solution
must be sterile. The biggest advantage of IV preparations is that as there are
no absorption phases, the drug is rapidly distributed to give quick action inside
the body.
 Example: Glucose preparations
■ Intramuscular (IM)
– It is the injection of a liquid directly into the muscle.
 Example: Different vaccines are made as IM preparations, Like BCG vaccine,
■ Subcutaneous injection
– In this injection, the liquid is directly pushed into the cutis, the layer below
dermis and epidermis of skin.
 Example: Insulins
Ophthalmic preparations
These medications are
generally liquid or semi
solid cream in nature and
are intended for
application to the
conjunctiva or the eyelids.
They are used to prevent
eye infections and so must
be sterile.
Example: Vaseline (Soft
paraffin)
Otic Preparations
Otic preparations are products
applied to or in the ear to treat
conditions of the external and
middle ear. These products are used
to treat dermatitis of the ear,
cerumen build up and ear infection.
Example: Borofair (acetic acid/
aluminium acetate)
Rectal and Vaginal Preparations
■ Rectal Preparations
– Rectal medicines are medications prepared specifically for insertion into
the rectum. They are compounded in many forms. Among them the most
popular and widely used are suppositories.
Suppositories are prepared by mixing medicine with a wax-like
substance to form a semi-solid, bullet-shaped form that will
melt after insertion into the rectum.
 Ex: Paracetamol suppositories
■ Vaginal Preparations
– Vaginal preparations are products, which are applied or inserted in
the vagina to treat vaginal conditions. They may contain antibacterial or
antifungal agents to treat infection, or they have agents such as
hormones that relieve menopausal symptoms. Most common ones are
1) Pessary
2) Vaginal Ring
3) Douche
 Ex: Vagifem (Estradiol).
Inhalers and Nose
drops
■ Inhalers:
– a portable device for administering a drug which is to
be breathed in, used for relieving asthma and other
bronchial or nasal congestion
 Example: Insulin Inhalers
■ Nasal drops:
– Nasal drops are liquid preparations that are designed
to be administered by the nose cavity in order to treat
nasal infections.
 Example: Oxymetazoline hydrochloride (Afrin)
Qualitative evaluation
■ Diazoxide
– Dosage form: Injection, Tablet
– Source: British Pharmacopoeia, Page 1970, Volume 1 and 2
– Activity: Vasodilator (used for hypertension)
– Process: First, we dissolve 50.0 mg in 5 ml of 1 M sodium
hydroxide and dilute to 50.0 ml with water R. Dilute 1.0 ml
of this solution to 100.0 ml with 0.1 M sodium hydroxide.
Then we examine it between 230 nm and 350 nm
(2.2.25), the solution shows an absorption maximum at
280 nm and a shoulder at 304 nm. The specific absorbance
is present at the maximum is 570 to 610.
1. By using Spectrophotometry
1. By using Spectrophotometry (cont.)
■ Dicloverine Hydrochloride
– Dosage form: Tablet, Oral Solution.
– Source: British Pharmacopoeia, Page 1902, Volume 1 and 2
– Activity: Vasodilator (used for hypertension)
– Process: We examine by infrared absorption spectrophotometry
comparing with the spectrum obtained with dicycloverine
hydrochloride CRS. Then we need to examine the substances
prepared as discs using potassium chloride R. If the spectra
obtained show differences, dissolve the substance to be examined
and he reference substance separately in acetone R,
evaporate to dryness and record new spectra using the residues.
Other Drugs that are also identified vis Spectroscopy
 Cyclizine Hydrochloride
 Dosage form: Injection, Tablet
 Source: British Pharmacopoeia, Page 1623, Volume 1 and 2
 Diazepam
 Dosage form: Oral solution, rectal solution, tablet
 Source: British Pharmacopoeia, Page 1836, Volume 1 and 2
2. By using potentiometry
■ Ebastine
– Dosage form: Coated tablet
– Source: British Pharmacopoeia, Page 2173, Volume 1 and 2
– Activity: H1 receptor blocker
– Process: Dissolve 0.350 g in 50 ml of anhydrous acetic acid
R. Titrate with 0.1 M perchloric acid, determining the end-
point potentiometrically. 1 ml of 0.1 M perchloric acid is
equivalent o 46.97 mg of C32H39NO2.
■ Econazole Nitrate
– Dosage form: Cream, Pessaries
– Source: British Pharmacopoeia, Page 2177, Volume 1 and 2
– Activity: Antifungal
– Process: Dissolve 0.400 g in 50 ml of anhydrous acetic acid R.
Titrate with 0.1 M perchloric acid, determining the end-point
potentiometrically (2.2.20). Carry out a blank titration. 1 ml
of 0.1 M perchloric acid is equivalent to 44.47 mg of
C18H16Cl3N3O4.
2. By using potentiometry (cont.)
■ Edrophonium chloride
– Dosage form: Injection
– Source: British Pharmacopoeia, Page 2189, Volume 1 and 2
– Activity: Cholinesterase inhibitor.
– Process: Dissolve 0.150 g in 60 ml of a mixture of equal volumes of
acetic anhydride R and anhydrous acetic acid R. Titrate with 0.1
M perchloric acid, determining the end-point potentiometrically.
1 ml of 0.1 M perchloric acid is equivalent to 20.17 mg of
C10H16ClNO.
■ Ethambutol Hydrochloride
– Dosage form: Tablets
– Source: British Pharmacopoeia, Page 2327, Volume 1 and 2
– Activity: Antituberculosis drug
– Process: Dissolve 0.200 g in 50 ml of water R and add 1.0 ml of 0.1 M
hydrochloric acid . Carry out a potentiometric titration (2.2.20),
using 0.1 M sodium hydroxide. Read the volume added
between the 2 points of inflexion. 1 ml of 0.1 M sodium hydroxide is
equivalent to 27.72 mg of C10H26Cl2N2O2..
3. By using Conductometry
■ Tiemonium Methyl sulfate
– Dosage form: tablet
– Activity: Anticholinergic (for peptic ulcer)
– Source: Page 149-159 Indian Journal of
Advances in Chemical Science 4(2) (2016)
■ Alizapide Hydrochloride
– Dosage form: tablet and ampoule
– Activity: Antiemetic drug
– Source: Page 149-159 Indian Journal of Advances in
Chemical Science 4(2) (2016)

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Different Dosage forms and their identification techniques

  • 1. DIFFERENT DOSAGE FORMS AND THEIR EVALUATION TECHNIQUES Ashit Kumar Dutta 171142 Pharmacy Discipline, Khulna University
  • 2. Introduction to Dosage Forms ■ What is a dosage form? – Dosage forms are pharmaceutical drug products in the form in which they are marketed for use , with a specific mixture of active ingredients and inactive components, in a particular configuration, and apportioned into a particular dose. – Examples: Tablets, capsules , syrups etc. ■ Why is a dosage form necessary? – Accurate dose – Protection of ingredients form external and internal damages (ex- gastric acids) – Controlling the release of medicaments – Optimizing drug activity by letting drug reach the appropriate site of action easily – Patient compliance
  • 3. Different Types of Dosage Forms ■ Depending on the physical form – Solid Dosage Forms – Liquid Dosage Forms – Gaseous Dosage Forms ■ Depending on route of administration – Oral – Topical – Rectal – Vaginal – Parenteral (IV, IM, IC) – Inhaled – Ophthalmic – Optic
  • 4. Oral Dosage Forms 1. Tablets ■ Definition: – A tablet is a hard, compressed medication in round, oval or square shape . – It mainly includes excipients such as binders, disintegrates, coating materials, sweeteners, disintegrates, glidants. ■ Subtypes of tablets: – Compressed tablets (ex: paracetamol) – Coated tablet (ex: riboflavin) – Buccal or sublingual tablet (ex: nitroglycerin) – Effervescent tablet (ex: disprin) – Chewable tablet (ex: gestid – chewable antacid) – Pastilles – Dental cones (ex: dental mirror)
  • 5. Coated tablets ■ Definition: – A tablet coating is a covering over a tablet, used to mask the taste, make it easier to swallow, or protect the active medication inside.  Types of coating tablets: o Enteric coated tablets: An enteric coating is a polymer barrier applied on oral medication that prevents its dissolution or disintegration in the gastric environment. Example: Erythromycin, Omeprazole o Sugar coated tablets: In this type of tablets a layer of sugar is applied on top of the tablet. This is done in order to mask the tablet from the bitter taste of the active ingredients. The sugar layer also acts as a preservative to protect the tablet from microbial attacks. Example: Advil – Ibuprofen o Film coated tablets: A film coating is a thin polymer-based coat applied to a solid dosage form such as a tablet Example: Diclofenac Potassium USP
  • 6. DIFFFERENT TYPES OF COATED TABLETS SUGAR COATED TABLETS ENTERIC COATED TABLETS FILM COATED TABLETS
  • 7. Compressed tablets: ■ A tablet prepared usually as a large-scale production, by means of great pressure; most compressed tablets consist of the active ingredient and a diluent, binder, disintegrator and lubricant. Example: Paracetamol tablet Effervescent tablets: ■ Effervescent or carbon tablets are tablets which are designed to dissolve in water, and release carbon dioxide Example: Disprin tablet (Asprin)
  • 8. Buccal or sublingual tablets: Definition. Sublingual and buccal medications are administered by placing them in the mouth, either under the tongue (sublingual) or between the gum and the cheek (buccal). The medications dissolve rapidly and are absorbed through the mucous membranes of the mouth, where they enter into the bloodstream. Example: Nitroglycerin Chewable tablets: Chewable tablets are big sized tablets which are difficult to swallow and thus, are chewed within the buccal cavity prior to swallowing. Example: Magnesium trisilicate tablets
  • 9. Dental cones: A solid bounded by a circular base converging upon a single vertex and intended for administration to the teeth and gingiva in the oral cavity. This is cone with the intention preventing microbial contamination and at the same time keeping the teeth cavity in appropriate size. Example: Dental Mirror
  • 10. 2. Capsule ■ What are capsules? – Capsule is a medicine contained in a water-soluble gelatin shell.. The shell is used to protect the API from degradation due to any gastric materials. There are generally two types of capsules.  Hard gelatin capsule  Soft gelatin capsule Ex: Doxicap (Doxicycline capsules)
  • 11. 3. Liquid Preparations This medications are taken orally but they are physically liquid. ■ Oral Syrups – These are liquid preparations which are concentrated solutions of sugar; mainly sucrose.  Example: Napa syrup (Paracetamol) ■ Oral Emulsions – This is a suspension of droplets of two phases mixed homogenously. In case of medical emulsions it is mainly oil in water solution.  Example: Liquid Paraffin
  • 12. 3. Liquid Preparations (cont.) ■ Oral Suspension – Oral suspensions are liquid solution where solid active ingredients remain suspended inside the vehicle of the container. This medication are needed to be shaken before use other wise the medications will settle down and the mixture will not be homogenous.  Example: Phenytoin suspensions. ■ Gargles and mouth washes – These are liquid preparations, mainly used to prevent oral or throat infections.  Example: Listerine mouth wash.
  • 13. Topical Preparations ■ Ointments – These are semi solid greasy preparations for application in skin , rectum, vagina or in nasal mucosa.  Example: Clobetasol Propionate ointment. ■ Creams – These are semi solid emulsions which means a biphasic preparation. Oil in water or water in oil  Example: Clotrimazole cream. ■ Powders – These are preparations of fine particles intended mainly for application on skin. They are mainly used to prevent contamination or keep the wounded place dry to prevent microbial growth  Example: Nebanol powder (mixture of Neomycin sulphate and Bacitracin Zinc) ■ Pastes – These are mainly ointments with a high concentration of fine solid particles.  Example: 30% salicylic acid
  • 14. Parenteral Preparations Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants. They are sterile preparations intended to be administrated directly into the systemic circulation in humans or animals. ■ Intra venous (IV) – It is a liquid administered directly into the bloodstream via a vain. The solution must be sterile. The biggest advantage of IV preparations is that as there are no absorption phases, the drug is rapidly distributed to give quick action inside the body.  Example: Glucose preparations ■ Intramuscular (IM) – It is the injection of a liquid directly into the muscle.  Example: Different vaccines are made as IM preparations, Like BCG vaccine, ■ Subcutaneous injection – In this injection, the liquid is directly pushed into the cutis, the layer below dermis and epidermis of skin.  Example: Insulins
  • 15. Ophthalmic preparations These medications are generally liquid or semi solid cream in nature and are intended for application to the conjunctiva or the eyelids. They are used to prevent eye infections and so must be sterile. Example: Vaseline (Soft paraffin) Otic Preparations Otic preparations are products applied to or in the ear to treat conditions of the external and middle ear. These products are used to treat dermatitis of the ear, cerumen build up and ear infection. Example: Borofair (acetic acid/ aluminium acetate)
  • 16. Rectal and Vaginal Preparations ■ Rectal Preparations – Rectal medicines are medications prepared specifically for insertion into the rectum. They are compounded in many forms. Among them the most popular and widely used are suppositories. Suppositories are prepared by mixing medicine with a wax-like substance to form a semi-solid, bullet-shaped form that will melt after insertion into the rectum.  Ex: Paracetamol suppositories ■ Vaginal Preparations – Vaginal preparations are products, which are applied or inserted in the vagina to treat vaginal conditions. They may contain antibacterial or antifungal agents to treat infection, or they have agents such as hormones that relieve menopausal symptoms. Most common ones are 1) Pessary 2) Vaginal Ring 3) Douche  Ex: Vagifem (Estradiol).
  • 17. Inhalers and Nose drops ■ Inhalers: – a portable device for administering a drug which is to be breathed in, used for relieving asthma and other bronchial or nasal congestion  Example: Insulin Inhalers ■ Nasal drops: – Nasal drops are liquid preparations that are designed to be administered by the nose cavity in order to treat nasal infections.  Example: Oxymetazoline hydrochloride (Afrin)
  • 18. Qualitative evaluation ■ Diazoxide – Dosage form: Injection, Tablet – Source: British Pharmacopoeia, Page 1970, Volume 1 and 2 – Activity: Vasodilator (used for hypertension) – Process: First, we dissolve 50.0 mg in 5 ml of 1 M sodium hydroxide and dilute to 50.0 ml with water R. Dilute 1.0 ml of this solution to 100.0 ml with 0.1 M sodium hydroxide. Then we examine it between 230 nm and 350 nm (2.2.25), the solution shows an absorption maximum at 280 nm and a shoulder at 304 nm. The specific absorbance is present at the maximum is 570 to 610. 1. By using Spectrophotometry
  • 19. 1. By using Spectrophotometry (cont.) ■ Dicloverine Hydrochloride – Dosage form: Tablet, Oral Solution. – Source: British Pharmacopoeia, Page 1902, Volume 1 and 2 – Activity: Vasodilator (used for hypertension) – Process: We examine by infrared absorption spectrophotometry comparing with the spectrum obtained with dicycloverine hydrochloride CRS. Then we need to examine the substances prepared as discs using potassium chloride R. If the spectra obtained show differences, dissolve the substance to be examined and he reference substance separately in acetone R, evaporate to dryness and record new spectra using the residues. Other Drugs that are also identified vis Spectroscopy  Cyclizine Hydrochloride  Dosage form: Injection, Tablet  Source: British Pharmacopoeia, Page 1623, Volume 1 and 2  Diazepam  Dosage form: Oral solution, rectal solution, tablet  Source: British Pharmacopoeia, Page 1836, Volume 1 and 2
  • 20. 2. By using potentiometry ■ Ebastine – Dosage form: Coated tablet – Source: British Pharmacopoeia, Page 2173, Volume 1 and 2 – Activity: H1 receptor blocker – Process: Dissolve 0.350 g in 50 ml of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end- point potentiometrically. 1 ml of 0.1 M perchloric acid is equivalent o 46.97 mg of C32H39NO2. ■ Econazole Nitrate – Dosage form: Cream, Pessaries – Source: British Pharmacopoeia, Page 2177, Volume 1 and 2 – Activity: Antifungal – Process: Dissolve 0.400 g in 50 ml of anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically (2.2.20). Carry out a blank titration. 1 ml of 0.1 M perchloric acid is equivalent to 44.47 mg of C18H16Cl3N3O4.
  • 21. 2. By using potentiometry (cont.) ■ Edrophonium chloride – Dosage form: Injection – Source: British Pharmacopoeia, Page 2189, Volume 1 and 2 – Activity: Cholinesterase inhibitor. – Process: Dissolve 0.150 g in 60 ml of a mixture of equal volumes of acetic anhydride R and anhydrous acetic acid R. Titrate with 0.1 M perchloric acid, determining the end-point potentiometrically. 1 ml of 0.1 M perchloric acid is equivalent to 20.17 mg of C10H16ClNO. ■ Ethambutol Hydrochloride – Dosage form: Tablets – Source: British Pharmacopoeia, Page 2327, Volume 1 and 2 – Activity: Antituberculosis drug – Process: Dissolve 0.200 g in 50 ml of water R and add 1.0 ml of 0.1 M hydrochloric acid . Carry out a potentiometric titration (2.2.20), using 0.1 M sodium hydroxide. Read the volume added between the 2 points of inflexion. 1 ml of 0.1 M sodium hydroxide is equivalent to 27.72 mg of C10H26Cl2N2O2..
  • 22. 3. By using Conductometry ■ Tiemonium Methyl sulfate – Dosage form: tablet – Activity: Anticholinergic (for peptic ulcer) – Source: Page 149-159 Indian Journal of Advances in Chemical Science 4(2) (2016) ■ Alizapide Hydrochloride – Dosage form: tablet and ampoule – Activity: Antiemetic drug – Source: Page 149-159 Indian Journal of Advances in Chemical Science 4(2) (2016)