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DOSAGE FORMS:AN OVERALL
INTRODUTION
B y
Adinath Babasaheb Sangale
Master Of Pharmacy
MES College Of Pharmacy Sonai , Ahmednagar , 414105
DOSAGE FORM
 Dosage forms are the mechanism by which drug
molecules / APIs are administered to areas of
action inside the body to generate maximum
intended benefits and the lowest unwanted effects.
 OR The Dosage form is the combination of Active
Pharmaceutical Ingredients (API) and Excipients in
the formulation.
THE NEED OF DOSAGE FORMS
 1. Deliver precise dosages in a safe and easy manner.
Example – Tablets, capsules, syrups
 2. Cover bitter taste or odor of drug substances. Example –
Capsules, coated tablets, flavored syrups
 3. Insoluble or unstable in the selected vehicle, provide a
liquid formulation of the insoluble or unstable medication.
Example – Suspension
 4. Controlled-release methods prolong the duration of
medication effect. Example – Controlled release tablets,
capsules, suspensions
 5. After oral delivery, a drug substance is protected from
stomach acid. Example – Enteric-coated tablets
 6. Provide optional drug action from topical administration
sites. Example – Ointment, cream, ear and nasal preparations
THE NEED OF DOSAGE FORMS
 7. Drugs can be injected into the body's tissues. Example –
Implants
 8. Inhalation treatment is the most effective way to get
optimum medication activity. Example – Inhalants
 9. Liquid dosage forms of chemicals soluble in the vehicle of
your choice. Example – Solution
 10. Provide for the introduction of medication into the body’s
orifice. Example – Rectal and vaginal suppositories
 11. Protection of a drug substance from atmospheric oxygen
or moisture. Example – Coated capsules, sealed ampules
GENERAL CONSIDERATIONS IN
DOSAGE FROM DESIGN
 Before formulating a drug substance into a dosage from, the
desired product type must be determined as far as possible to
establish the framework for product development. The
formulation that best meets the goals for the product is
selected to be its master formula. Each batch of product
subsequently prepared must meet the specifications
established in the master formula.
 These liquids, which are flavored aqueous solutions, syrups or
suspensions are usually administered directly into the infant’s
or child’s mouth by drop, spoon or oral dispenser or
incorporated into the child’s food. A single liquid pediatric
preparation may be used for infants and children of all ages,
with the dose of the drug varied by the volume administered.
Infant-size rectal suppositories may also be employed,
although drug absorption from the rectum is often erratic
GENERAL CONSIDERATIONS IN
DOSAGE FROM DESIGN
 Some medications are formulated as chewable tablets. Newly
available tablets dissolve in the mouth in about 10 to 15
seconds. This allows the patient to take a tablet but actually
swallow a liquid.
 Medications intended for the elderly are commonly formulated
into oral liquid or may be extemporaneously prepared into an
oral liquid by the pharmacist
TYPES OF DOSAGE FORMS
 There are different forms into which a drug may be placed
(regulated/given or taken) for convenient and effective
treatment of disease. Drugs can be prepared for
administration by very conceivable route and the suitable
preparation is formulated to insure maximum therapeutic
response.
 These may be tablets, capsules, solutions, syrups, elixirs,
suspensions, gels, powders, troches or lozenge , ointments,
creams, pastes, aerosol, lotions, sprays, inhalants, emulsions
and suppositories .The preferred dosage forms in different
routes of administration is listed
TYPES OF DOSAGE FORMS
CAPSULES
 Capsule are the solid unit dosage form of
medicament in which the drug or drugs are
enclosed in a practically tasteless, hard or soft
soluble container of shell made up of gelatin.
 Hard gelatin capsules -
Hard gelatin capsules are made up of two
cylindrical halves, one slightly larger in diameter but
shorter in length known as cap and the other
slightly shorter in diameter but longer in length
known as base. Soft gelatin capsules are flexible in
nature. They may be spherical, ovoid cylindrical or
tubes. The small spherical capsules are also known
as ‘pearls’.
CAPSULES
 Soft gelatin capsules
Soft gelatin capsules are flexible in nature. They
may be spherical, ovoid cylindrical or tubes. The
small spherical capsules are also known as ‘pearls’.
Soft gelatin capsules are used to enclose solids,
semisolids or liquids for oral administration the
capsule is placed on the tongue and swallowed with
a drink of water. Examples of hard gelatin capsules:
Ampicillin capsules, multivitamin capsules.
Examples of soft gelatin capsules: chloramphenicol
soft gelatin capsules.
TABLETS
 Tablets are unit solid dosage form of medicament or
medicament with or without suitable diluents. They
are prepared usually by compression. Tablets are
generally meant for oral administration but may be
used by other routes of administration. E.g.-
paracetamol tablets.
CACHETS
 Cachets consists of a dry powder enclosed in a
shell. The shell is prepared from a mixture of rice
flour and water by moulding into suitable shape and
then dried.
 Two types of cachets are there:
 (i) Wet seal cachets: Lower half of the cachet is
filled with powdered drug. Then the flange of the
empty upper half of the cachet is moistened with
water, and pressed over the lower half. The cachet
is dried for 15 minutes.
 (ii)Dry seal cachets: Drug powder is filled in the
lower half and the upper half is pressed over it just
like a capsule
CACHETS
 . Use: They are used for administering the drug with
unpleasant taste and a large dose. Before
administration, a cachet should be immersed in
water for few seconds and then placed on the
tongue and swallowed with water. e.g. - Sodium
aminosalicylate cachets, Sodium aminosalicylate
and isoniazid cachets.
DUSTING POWDER
o These are meant for external application on to the
skin and are generally applied in a very fine state of
subdivision to avoid local irritation.
o Dusting powders are of two types:
o (i) Medical (ii) Surgical Medical dusting powders are
mainly used for superficial skin conditions and for
antiseptics, anti- pruritic, astringent, anti-perspirant,
absorbent, protective and lubricant purposes.
o E.g. dicophane dusting powder, zinc and salicylic
acid dusting powder
LOZENGES
 Lozenges are solid dosage form of medicaments
which are meant for slow dissolution in the mouth.
 Along with medicament they contain a sweetening
agent, flavoring agent and a strong binding agent.
 They may be prepared either by moulding or by
compression. Examples are compound bismuth
lozenges, liquor ice lozenges
PESSARIES
 Pessaries are solid unit dosage form of
medicament meant for introduction into vagina.
 The bases used for the manufacture of pessaries
are such that at room temperature they retain the
original shape but when inserted into the body
cavity either it melts or dissolve in the cavity fluids
to release the medicament.
SUPPOSITORIES
 Suppositories are special shaped solid dosage form
of medicament for insertion into body cavities other
than mouth.
 These products are so formulated that after
insertion, they will either melt of dissolve in the
cavity fluids to release the medicament.
 Suppositories vary in shapes, sizes and weights.
General suppositories from 1 to 2 gm are prepared
with either cocoa-butter or glycerol- gelatin base.
E.g. aminophylline.
SEMISOLID DOSAGE FORMS: CREAMS
 Creams are viscous liquid or semisolid emulsions
intended for application to the skin i.e. for external use.
 Creams are of two types, aqueous creams and oily
creams. In case of aqueous creams the emulsions are
oil-in-water type and in case of oily creams emulsions
are of water-in-oil type. e.g. cetomacrogol cream,
cetrimide cream.
 Advantages of creams:
 1. Creams are more acceptable to the patients because
they are less greasy and are easier to apply.
 2. They interfere less with skin functions.
 3. O/w type of creams can be rub onto the skin more
readily and are easily removed by washing. W/o can be
spread more evenly. 4
CREAMS
 4. O/w type of cream are less likely to soil clothes.
5. Evaporation of water from o/w type of cream
causes cooling sensation.
 6. O/w creams absorbs the discharges from the
wound very quickly
CREAMS
 Disadvantages:
1. Since it is a semisolid preparation and containing
oil in large amount, some of which are inedible,
hence creams are not used for internal use.
Basically creams are meant for application onto the
skin.
 2. The aqueous phase is prone to the growth of
molds and bacteria hence preservatives should be
used.
 3. Sometimes acidification of oils take place
OINTMENTS
 Ointments are the soft semisolid, greasy
preparations meant for external application onto the
skin or mucous membrane (rectum and nasal
mucosa).
 They usually contain a medicament dissolved,
suspended or emulsified in the base.
 Ointments are used for their emollient and
protective action to the skin. E.g.-compound
benzoic acid ointment, certified emulsifying
ointment
PASTES
 Pastes are semisolid preparations meant for
external application to the skin.
 They generally contain large amount of finely
powdered solids such as starch, zinc oxide, calcium
carbonate etc.
 They provide a protective coating over the areas to
which they are applied.
 The base may be anhydrous (liquid or soft paraffin)
or water-soluble (glycerol or a mucilage).
 Their stiffness make them useful as protective
coatings. E.g.- magnesium sulfate paste
LIQUIDS DOSAGE FORMS- AROMATIC
WATERS
 Aromatic waters are also known as medicated
waters.
 They are dilute, usually saturated, aqueous
solutions of volatile oils (e.g. peppermint oil,
cinnamon oil) or volatile substances (e.g. camphor).
 Uses: (i) Some of them have a mild therapeutic
action
 (ii) Mainly they are used as flavoring agents in
preparations meant for internal use.
SYRUPS
 :Syrups are liquid oral preparations in which the
vehicle is a concentrated aqueous solution of
sucrose or other sugar.
 Advantages of syrups
 1. Syrups retards oxidation because it is partly
hydrolyzed into reducing sugar such as dextrose
and laevulose.
 2. It prevents decomposition of many vegetable
substances. Syrups have high osmotic pressure
which prevents the growth of bacteria, fungi and
molds which are the chief causes of decomposition
in solutions of vegetable matter.
SYRUPS
 3. They are palatable. Due to the sweetness of
sugar it is a valuable vehicle for the administration
of unpalatable substances.
ELIXIRS:
 Elixirs are clear, liquid, oral preparations of potent
or nauseous drugs.
 They are pleasantly flavored and usually attractively
colored and are very stable.
 They are used for the production of clear solution.
Essential oils from flavoring agents may produce
faint opalescence, hence alcohol 10 20% is useful
for keeping oils in solution.
LINCTUSES:
 Linctus’s are viscous, liquid, oral preparations that are
usually prescribed for the relief of cough.
 They contain medicaments which have demulcent
(which soothes the inflamed mucous membrane
preventing contact with air in the surroundings), sedative
or expectorant action. The viscous vehicle soothes the
sore membrane of the throat.
 The usual dose is 5 ml. Linctus’s should be taken in
small doses, sipped and swallowed slowly without
diluting it with water in order to have the maximum and
prolonged effect of medicaments.
 Simple Syrup is generally used as a vehicle. For
diabetic patients Sorbitol solution is used instead of
Simple Syrup

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PHARMACEUTICAL DOSAGE FORMS : an overall introduction .pptx

  • 1. DOSAGE FORMS:AN OVERALL INTRODUTION B y Adinath Babasaheb Sangale Master Of Pharmacy MES College Of Pharmacy Sonai , Ahmednagar , 414105
  • 2. DOSAGE FORM  Dosage forms are the mechanism by which drug molecules / APIs are administered to areas of action inside the body to generate maximum intended benefits and the lowest unwanted effects.  OR The Dosage form is the combination of Active Pharmaceutical Ingredients (API) and Excipients in the formulation.
  • 3. THE NEED OF DOSAGE FORMS  1. Deliver precise dosages in a safe and easy manner. Example – Tablets, capsules, syrups  2. Cover bitter taste or odor of drug substances. Example – Capsules, coated tablets, flavored syrups  3. Insoluble or unstable in the selected vehicle, provide a liquid formulation of the insoluble or unstable medication. Example – Suspension  4. Controlled-release methods prolong the duration of medication effect. Example – Controlled release tablets, capsules, suspensions  5. After oral delivery, a drug substance is protected from stomach acid. Example – Enteric-coated tablets  6. Provide optional drug action from topical administration sites. Example – Ointment, cream, ear and nasal preparations
  • 4. THE NEED OF DOSAGE FORMS  7. Drugs can be injected into the body's tissues. Example – Implants  8. Inhalation treatment is the most effective way to get optimum medication activity. Example – Inhalants  9. Liquid dosage forms of chemicals soluble in the vehicle of your choice. Example – Solution  10. Provide for the introduction of medication into the body’s orifice. Example – Rectal and vaginal suppositories  11. Protection of a drug substance from atmospheric oxygen or moisture. Example – Coated capsules, sealed ampules
  • 5. GENERAL CONSIDERATIONS IN DOSAGE FROM DESIGN  Before formulating a drug substance into a dosage from, the desired product type must be determined as far as possible to establish the framework for product development. The formulation that best meets the goals for the product is selected to be its master formula. Each batch of product subsequently prepared must meet the specifications established in the master formula.  These liquids, which are flavored aqueous solutions, syrups or suspensions are usually administered directly into the infant’s or child’s mouth by drop, spoon or oral dispenser or incorporated into the child’s food. A single liquid pediatric preparation may be used for infants and children of all ages, with the dose of the drug varied by the volume administered. Infant-size rectal suppositories may also be employed, although drug absorption from the rectum is often erratic
  • 6. GENERAL CONSIDERATIONS IN DOSAGE FROM DESIGN  Some medications are formulated as chewable tablets. Newly available tablets dissolve in the mouth in about 10 to 15 seconds. This allows the patient to take a tablet but actually swallow a liquid.  Medications intended for the elderly are commonly formulated into oral liquid or may be extemporaneously prepared into an oral liquid by the pharmacist
  • 7. TYPES OF DOSAGE FORMS  There are different forms into which a drug may be placed (regulated/given or taken) for convenient and effective treatment of disease. Drugs can be prepared for administration by very conceivable route and the suitable preparation is formulated to insure maximum therapeutic response.  These may be tablets, capsules, solutions, syrups, elixirs, suspensions, gels, powders, troches or lozenge , ointments, creams, pastes, aerosol, lotions, sprays, inhalants, emulsions and suppositories .The preferred dosage forms in different routes of administration is listed
  • 9. CAPSULES  Capsule are the solid unit dosage form of medicament in which the drug or drugs are enclosed in a practically tasteless, hard or soft soluble container of shell made up of gelatin.  Hard gelatin capsules - Hard gelatin capsules are made up of two cylindrical halves, one slightly larger in diameter but shorter in length known as cap and the other slightly shorter in diameter but longer in length known as base. Soft gelatin capsules are flexible in nature. They may be spherical, ovoid cylindrical or tubes. The small spherical capsules are also known as ‘pearls’.
  • 10. CAPSULES  Soft gelatin capsules Soft gelatin capsules are flexible in nature. They may be spherical, ovoid cylindrical or tubes. The small spherical capsules are also known as ‘pearls’. Soft gelatin capsules are used to enclose solids, semisolids or liquids for oral administration the capsule is placed on the tongue and swallowed with a drink of water. Examples of hard gelatin capsules: Ampicillin capsules, multivitamin capsules. Examples of soft gelatin capsules: chloramphenicol soft gelatin capsules.
  • 11. TABLETS  Tablets are unit solid dosage form of medicament or medicament with or without suitable diluents. They are prepared usually by compression. Tablets are generally meant for oral administration but may be used by other routes of administration. E.g.- paracetamol tablets.
  • 12. CACHETS  Cachets consists of a dry powder enclosed in a shell. The shell is prepared from a mixture of rice flour and water by moulding into suitable shape and then dried.  Two types of cachets are there:  (i) Wet seal cachets: Lower half of the cachet is filled with powdered drug. Then the flange of the empty upper half of the cachet is moistened with water, and pressed over the lower half. The cachet is dried for 15 minutes.  (ii)Dry seal cachets: Drug powder is filled in the lower half and the upper half is pressed over it just like a capsule
  • 13. CACHETS  . Use: They are used for administering the drug with unpleasant taste and a large dose. Before administration, a cachet should be immersed in water for few seconds and then placed on the tongue and swallowed with water. e.g. - Sodium aminosalicylate cachets, Sodium aminosalicylate and isoniazid cachets.
  • 14. DUSTING POWDER o These are meant for external application on to the skin and are generally applied in a very fine state of subdivision to avoid local irritation. o Dusting powders are of two types: o (i) Medical (ii) Surgical Medical dusting powders are mainly used for superficial skin conditions and for antiseptics, anti- pruritic, astringent, anti-perspirant, absorbent, protective and lubricant purposes. o E.g. dicophane dusting powder, zinc and salicylic acid dusting powder
  • 15. LOZENGES  Lozenges are solid dosage form of medicaments which are meant for slow dissolution in the mouth.  Along with medicament they contain a sweetening agent, flavoring agent and a strong binding agent.  They may be prepared either by moulding or by compression. Examples are compound bismuth lozenges, liquor ice lozenges
  • 16. PESSARIES  Pessaries are solid unit dosage form of medicament meant for introduction into vagina.  The bases used for the manufacture of pessaries are such that at room temperature they retain the original shape but when inserted into the body cavity either it melts or dissolve in the cavity fluids to release the medicament.
  • 17. SUPPOSITORIES  Suppositories are special shaped solid dosage form of medicament for insertion into body cavities other than mouth.  These products are so formulated that after insertion, they will either melt of dissolve in the cavity fluids to release the medicament.  Suppositories vary in shapes, sizes and weights. General suppositories from 1 to 2 gm are prepared with either cocoa-butter or glycerol- gelatin base. E.g. aminophylline.
  • 18. SEMISOLID DOSAGE FORMS: CREAMS  Creams are viscous liquid or semisolid emulsions intended for application to the skin i.e. for external use.  Creams are of two types, aqueous creams and oily creams. In case of aqueous creams the emulsions are oil-in-water type and in case of oily creams emulsions are of water-in-oil type. e.g. cetomacrogol cream, cetrimide cream.  Advantages of creams:  1. Creams are more acceptable to the patients because they are less greasy and are easier to apply.  2. They interfere less with skin functions.  3. O/w type of creams can be rub onto the skin more readily and are easily removed by washing. W/o can be spread more evenly. 4
  • 19. CREAMS  4. O/w type of cream are less likely to soil clothes. 5. Evaporation of water from o/w type of cream causes cooling sensation.  6. O/w creams absorbs the discharges from the wound very quickly
  • 20. CREAMS  Disadvantages: 1. Since it is a semisolid preparation and containing oil in large amount, some of which are inedible, hence creams are not used for internal use. Basically creams are meant for application onto the skin.  2. The aqueous phase is prone to the growth of molds and bacteria hence preservatives should be used.  3. Sometimes acidification of oils take place
  • 21. OINTMENTS  Ointments are the soft semisolid, greasy preparations meant for external application onto the skin or mucous membrane (rectum and nasal mucosa).  They usually contain a medicament dissolved, suspended or emulsified in the base.  Ointments are used for their emollient and protective action to the skin. E.g.-compound benzoic acid ointment, certified emulsifying ointment
  • 22. PASTES  Pastes are semisolid preparations meant for external application to the skin.  They generally contain large amount of finely powdered solids such as starch, zinc oxide, calcium carbonate etc.  They provide a protective coating over the areas to which they are applied.  The base may be anhydrous (liquid or soft paraffin) or water-soluble (glycerol or a mucilage).  Their stiffness make them useful as protective coatings. E.g.- magnesium sulfate paste
  • 23. LIQUIDS DOSAGE FORMS- AROMATIC WATERS  Aromatic waters are also known as medicated waters.  They are dilute, usually saturated, aqueous solutions of volatile oils (e.g. peppermint oil, cinnamon oil) or volatile substances (e.g. camphor).  Uses: (i) Some of them have a mild therapeutic action  (ii) Mainly they are used as flavoring agents in preparations meant for internal use.
  • 24. SYRUPS  :Syrups are liquid oral preparations in which the vehicle is a concentrated aqueous solution of sucrose or other sugar.  Advantages of syrups  1. Syrups retards oxidation because it is partly hydrolyzed into reducing sugar such as dextrose and laevulose.  2. It prevents decomposition of many vegetable substances. Syrups have high osmotic pressure which prevents the growth of bacteria, fungi and molds which are the chief causes of decomposition in solutions of vegetable matter.
  • 25. SYRUPS  3. They are palatable. Due to the sweetness of sugar it is a valuable vehicle for the administration of unpalatable substances.
  • 26. ELIXIRS:  Elixirs are clear, liquid, oral preparations of potent or nauseous drugs.  They are pleasantly flavored and usually attractively colored and are very stable.  They are used for the production of clear solution. Essential oils from flavoring agents may produce faint opalescence, hence alcohol 10 20% is useful for keeping oils in solution.
  • 27. LINCTUSES:  Linctus’s are viscous, liquid, oral preparations that are usually prescribed for the relief of cough.  They contain medicaments which have demulcent (which soothes the inflamed mucous membrane preventing contact with air in the surroundings), sedative or expectorant action. The viscous vehicle soothes the sore membrane of the throat.  The usual dose is 5 ml. Linctus’s should be taken in small doses, sipped and swallowed slowly without diluting it with water in order to have the maximum and prolonged effect of medicaments.  Simple Syrup is generally used as a vehicle. For diabetic patients Sorbitol solution is used instead of Simple Syrup