Orientation to Pharmacy 2014-Part 2

Al-Ain University of Science and Technology

College of PharmacyPart 2-

Orientation to Pharmacy

Dr. Khairi M. Salem 2014-2

11/24/2013 1Orientation Pharmacy part-2 Dr. Khairi M. Salem

Chapter 5,Chapter 5,Ethics in PharmacyEthics in Pharmacy

A group of behavior or characterbehavior or character supposed to ensure the compliance with society principles, which cover

Decision making , Competence and caring, Heath professional relationship, Moral rights, Legal rights and Patient rights

Code of Ethics: Code of Ethics: a set of standards , rules , guidelines and values that govern the profession of pharmacy..

• A pharmacist respect the covenantal relationship A pharmacist respect the covenantal relationship between the patient and pharmacist.between the patient and pharmacist.

• A pharmacist promotes the good of every patient A pharmacist promotes the good of every patient in caring and confidential.in caring and confidential.

• A pharmacist respects the autonomy and dignity A pharmacist respects the autonomy and dignity of each patient.of each patient.

• A pharmacist acts with honesty and integrity in A pharmacist acts with honesty and integrity in professional relationships.professional relationships.

• A pharmacist maintains professional competence.A pharmacist maintains professional competence.• A pharmacist serves individual community and A pharmacist serves individual community and

social needssocial needs• A pharmacist seeks justice in distribution of A pharmacist seeks justice in distribution of

health recourses. health recourses. 11/24/2013 2Orientation Pharmacy part-2 Dr. Khairi M.

Salem

Pharmaceutical Dosage Forms :Def.: These are product contain one or more active

ingredient (drug). And also called Drug delivery system.

These dosage forms contains one drug (s) formulated with certain inactive additives (excipients) .

Types of Dosage Forms:Types of Dosage Forms:1. According to physical state: A.A. Solid Solid asas Granules , Capsules and TabletsGranules , Capsules and TabletsB.B. LiquidsLiquids as as Solutions, Syrup, lotions, drops Solutions, Syrup, lotions, dropsC.C. Gas: Gas: AerosolsAerosols2. According to the route of administration: A.A. OralOral: oral powder, tablet, capsules, Syrups and oral : oral powder, tablet, capsules, Syrups and oral

dropsdropsB.B. Topical: Topical: Ointment, creams, lotionsOintment, creams, lotionsC.C. RectalRectal : Enemas, Suppositories : Enemas, SuppositoriesD.D. Parenteral: Parenteral: Intravenous (I.V), Intramuscular (I.M), Intravenous (I.V), Intramuscular (I.M), E.E. Interaperitoneal (IP) and Subcutaneous (S.C)Interaperitoneal (IP) and Subcutaneous (S.C)F.F. Ophthalmic preparationsOphthalmic preparations: Drops, Ointments and : Drops, Ointments and

Creams, Creams, G.G. NasalNasal : drops : drops


Why drug delivery System :1.1. To control the DosingTo control the DosingA.A. Unit Dose Product : Tablet, Capsule, Unit Dose Product : Tablet, Capsule,

Suppositories and ampoulesSuppositories and ampoulesB.B. Multiple dose product: syrup Multiple dose product: syrup C.C. Unit dose product control dosing much butterUnit dose product control dosing much butter2. To modify the dissolution in GIT2. To modify the dissolution in GIT3. To modify taste and order of drugs3. To modify taste and order of drugs4. To improve stability of unstable drugs4. To improve stability of unstable drugs

The requirements drug delivery System:The Why drug delivery System must be:The Why drug delivery System must be:1.1. Convenient for patient: easily swallowed, no Convenient for patient: easily swallowed, no

bitter taste, good odor, not irritant to bitter taste, good odor, not irritant to stomach stomach

2.2. It must be stable: light, humidity and It must be stable: light, humidity and temperaturetemperature

3.3. It must be therapeutically effectiveIt must be therapeutically effective4.4. It could be identifiedIt could be identified5.5. It must afford several doses, economic and It must afford several doses, economic and

elegant package elegant package 11/24/2013 4Orientation Pharmacy part-2 Dr. Khairi M. Salem


Assessment of the quality of the product

1.1. Stability of the product: SolidStability of the product: Solid< < semisolid semisolid <<liquidsliquids

2.2. Dissolution and Absorption: I.V. Solutions Dissolution and Absorption: I.V. Solutions <<oral oral liquids liquids <<suspension suspension <<capsules capsules << tablets tablets..

3.3. Manufacturing: Tablet Manufacturing: Tablet << Parenteral Parenteral4.4. Ease of use: Tablet Ease of use: Tablet << Parenteral Parenteral5.5. Proper dosing : Tablet Proper dosing : Tablet << syrup syrup6.6. Homogeneity: Liquid Dosage Forms Homogeneity: Liquid Dosage Forms << Tablet. Tablet.

Liquid Dosage Forms:Liquid Dosage Forms:Formulation:Formulation: important role of industrial pharmacist, important role of industrial pharmacist,

which carried out in R&D , it means the selection which carried out in R&D , it means the selection of the additives used to change the active of the additives used to change the active ingredient to the required dosage form.ingredient to the required dosage form.

1.1. For liquid dosage form there is a need for a For liquid dosage form there is a need for a solvent to dissolve or suspend the active solvent to dissolve or suspend the active ingredient.ingredient.

2.2. A flavoring agent is used to A flavoring agent is used to cover unpleasant cover unpleasant odorodor

3.3. A sweating agent is used to A sweating agent is used to cover unpleasant cover unpleasant tastetaste

4.4. A coloring agent is used to give attractive colorA coloring agent is used to give attractive color5.5. A preservative to avoid microbial growth,A preservative to avoid microbial growth,6.6. A stabilizer to ensure and enhance stabilityA stabilizer to ensure and enhance stability


Advantages:Advantages:1.1. Homogenous in content i.e.Homogenous in content i.e. no different in dosing.no different in dosing.2.2. Easy for administration i.e. for children and in sore Easy for administration i.e. for children and in sore

throat throat 3.3. No need for disintegration as tablet or dissolution as No need for disintegration as tablet or dissolution as

tablet and capsuletablet and capsule4.4. Less irritant for stomach.Less irritant for stomach.

Disadvantages:Disadvantages:1.1. Taste and odor problem.Taste and odor problem.2.2. Less stable. Needs preservative to avoid microbial Less stable. Needs preservative to avoid microbial

growth.growth.3.3. Less stable due to the water presence, needs Less stable due to the water presence, needs

antioxidant and colored container to avoid direct antioxidant and colored container to avoid direct effect of sunlight.effect of sunlight.

4.4. Heavy bottles difficult to carry and storage.Heavy bottles difficult to carry and storage.5.5. Parenteral or eye drops require sterility Parenteral or eye drops require sterility 6.6. Improper dosing , since they are multi dose formImproper dosing , since they are multi dose form11/24/2013 7Orientation Pharmacy part-2 Dr. Khairi M.

Salem

Solvents:Solvents:WaterWaterAdvantages:Advantages:1.1. Cheep. Cheep. 2.2. Wide rang of solubilityWide rang of solubility3.3. Inert: no chemical or Inert: no chemical or

pharmacological actionpharmacological action4.4. Colorless, odorless, tasteless and Colorless, odorless, tasteless and

neutralneutralDisadvantages:Disadvantages:1.1. A medium for degradation process. A medium for degradation process. 2.2. Dissolve sugars and proteins ( cause Dissolve sugars and proteins ( cause

bacterial growth & fermentation)bacterial growth & fermentation)3.3. May contain minerals or bacteriaMay contain minerals or bacteriaTypes of water: Types of water: 1. Tap water:1. Tap water:A.A. It contain minerals and microbesIt contain minerals and microbesB.B. Boiled then cold water may show Boiled then cold water may show

microbial growthmicrobial growthC.C. Not permitted to use in Liquid Not permitted to use in Liquid

dosage formsdosage forms


Purified Water:Purified Water:

A.A. Water free from total solids Water free from total solids >>10 10 ppmppm

B.B. Prepared by distillation or ion Prepared by distillation or ion exchange resinsexchange resins

C.C. Ion Exchange Resins are used to remove Ion Exchange Resins are used to remove minerals dissolved in water.minerals dissolved in water.


Water for injection:Water for injection:A.A. Free from Bacteria.Free from Bacteria.B.B. Free from PyrogenFree from PyrogenC.C. Free from minerals, total solids Free from minerals, total solids >>10 10

ppmppm..D.D. Used for sterile productsUsed for sterile productsE.E. Sterile water may be found up into 1 liter Sterile water may be found up into 1 liter

container.container.4. Bacteriostatic Water for injection:4. Bacteriostatic Water for injection:A.A. All the property listed under water for All the property listed under water for

injection.injection.B.B. Contains a bacteriostatic agent at Contains a bacteriostatic agent at

specific concentration. specific concentration. C.C. Used for vials or multiple dose productsUsed for vials or multiple dose products ..D.D. Volumes must not exceed 30 ml.Volumes must not exceed 30 ml.Ethyl Alcohol:Ethyl Alcohol:A.A. Free from Bacteria.Free from Bacteria.B.B. Free from PyrogenFree from PyrogenC.C. Free from minerals, total solids Free from minerals, total solids >>10 10

ppmppm..D.D. Used for sterile productsUsed for sterile productsEthyl Alcohol; Advantages :Ethyl Alcohol; Advantages :1.1. More specific for dissolving certain materials More specific for dissolving certain materials

( not dissolve sugars, gums and proteins.( not dissolve sugars, gums and proteins.2.2. Kills MicrobesKills Microbes3.3. Used to extract Alkaloids and glycosidesUsed to extract Alkaloids and glycosidesDisadvantages: Disadvantages: Volatile, Affects CNS, Liver, Volatile, Affects CNS, Liver,

GIT etc ( the solvent not accepted by GIT etc ( the solvent not accepted by Islam efforts should be carried out to Islam efforts should be carried out to replaced )replaced )11/24/2013 10Orientation Pharmacy part-2 Dr. Khairi M. Salem

Glycerol; Advantages :Glycerol; Advantages :1.1. Not volatile.Not volatile.2.2. Not toxic1Not toxic1Disadvantages: Disadvantages: 1.1. HygroscopicHygroscopic2.2. Dissolve gums, albumins and tanninsDissolve gums, albumins and tanninsCo-Solvency:Co-Solvency:1.1. Means the use of 2 solvents to enhance the solubility of certain Means the use of 2 solvents to enhance the solubility of certain

reagent.reagent.2.2. Examples as : Water/ Glycerol and Ethanol / WaterExamples as : Water/ Glycerol and Ethanol / WaterHydrotrophy: Hydrotrophy: The use of certain solutes ( sodium benzoate or The use of certain solutes ( sodium benzoate or

sodium salicylate to dissolve other material as cholesterol.sodium salicylate to dissolve other material as cholesterol.Soulbilization:Soulbilization:1.1. Vitamin D is insoluble in water, used as aqueous drops for Vitamin D is insoluble in water, used as aqueous drops for

children.children.2.2. It is required in the form of aqueous drops of childrenIt is required in the form of aqueous drops of children3.3. To enhance its solubility Soulbilization is required.To enhance its solubility Soulbilization is required.4.4. This involve the using of surfactant SLS, polysorbate 80 to This involve the using of surfactant SLS, polysorbate 80 to

solubilize the solubilize the 5.5. A specific concentration is used.A specific concentration is used.6.6. Improve both stability and stability and bioavailability of Improve both stability and stability and bioavailability of

drugs.drugs.


Flavoring Agents:Flavoring Agents:1.1. Overcome the problems of the drug taste..Overcome the problems of the drug taste..2.2. Bitter taste as drotaverine HCl (antitussive) is Bitter taste as drotaverine HCl (antitussive) is

covered by Cocoacovered by Cocoa3.3. Acid taste is covered by citrus, cinnamonAcid taste is covered by citrus, cinnamon4.4. Flavors are either soluble or insoluble in waterFlavors are either soluble or insoluble in water5.5. Some flavors are used to Some flavors are used to expel gasesexpel gases in flatulence or in flatulence or

improve digestionsimprove digestions Avoid the Avoid the crystals building in kidney crystals building in kidney and asand as mild mild

antibacterial agents antibacterial agents Sweeting Agents:Sweeting Agents:1.1. Sucrose:Sucrose:a.a. Favor the growth of microbes at low concentration.Favor the growth of microbes at low concentration.b.b. Sucrose is soluble in water 2:1Sucrose is soluble in water 2:1c.c. The concentration of its solution in water is 66%The concentration of its solution in water is 66%d.d. At 66% it prevent s the growth of micro-organismsAt 66% it prevent s the growth of micro-organismse.e. Contraindicated in diabetes and obesityContraindicated in diabetes and obesity2.2. Saccharin:Saccharin:a.a. It is synthetic , 500 sweeter than sucrose, used for It is synthetic , 500 sweeter than sucrose, used for

diabetes, not carcinogenic in proper dosediabetes, not carcinogenic in proper dose3. 3. AspartameAspartame a.a. It is 120-280 sweeter than sucrose.It is 120-280 sweeter than sucrose.b.b. Consists of two amino acid molecules.Consists of two amino acid molecules.c.c. It decomposes in presence of water ( provided in It decomposes in presence of water ( provided in

tablet ( solid formtablet ( solid form


Coloring Agents: Coloring Agents: To select a coloring To select a coloring agentagent::

1.1. Only use colors approved by FDAOnly use colors approved by FDA2.2. Colors are used for psychological Colors are used for psychological

factors as antidepressants, confidence factors as antidepressants, confidence as syrup or for identification as tablets as syrup or for identification as tablets and capsule and capsule

3.3. Natural colors (caramel) are better than Natural colors (caramel) are better than synthetic ones (tartrazines). Tartrazines synthetic ones (tartrazines). Tartrazines is not used due to allergyis not used due to allergy

4.4. Insure stability of the colorInsure stability of the color Preservative:Preservative:Agents used to prevent the growth of Agents used to prevent the growth of

microbes found in or added to the microbes found in or added to the container during the use of medicine.container during the use of medicine.

The preservative should have the following The preservative should have the following requirements:requirements:

• Safe, Soluble and StableSafe, Soluble and Stable• Compatible with all ingredients.Compatible with all ingredients.• Don’t interact with container or coverDon’t interact with container or coverExamples of PreservativesExamples of Preservatives::• Benzoic Acid 0.1-0.2% , Benzoic Acid 0.1-0.2% , • Sodium benzoate 0.1-0.2% ,Sodium benzoate 0.1-0.2% ,• Methyl Paraben & Propyl Paraben 0.1-Methyl Paraben & Propyl Paraben 0.1-

0.2% 0.2% • Phenyl mercuric nitrate 0.002-0.01%Phenyl mercuric nitrate 0.002-0.01%11/24/2013 13Orientation Pharmacy part-2 Dr. Khairi M. Salem

Stabilizers: Stabilizers: Agents used to enhance stabilityAgents used to enhance stability::1.1. Degradation occurs due to:Degradation occurs due to:a.a. Oxidation( in presence of water, O2 or Air)Oxidation( in presence of water, O2 or Air)b.b. Hydrolysis ( in presence of water at Hydrolysis ( in presence of water at

specific pH)specific pH)2. Factors favoring degradation (light (sun), 2. Factors favoring degradation (light (sun),

Heat (hot weather) catalyst) Heat (hot weather) catalyst) 3. Factors used to control Hydrolysis:3. Factors used to control Hydrolysis:a.a. Use of dry powder followed by Use of dry powder followed by

reconstitution just before use.reconstitution just before use.b.b. Use solvents such as glycerin and Use solvents such as glycerin and

propylene glycol.propylene glycol.c.c. Formulate at pH at which least Formulate at pH at which least

degradation takes place.degradation takes place.d.d. Store at low temp. not more than 25 Store at low temp. not more than 25 ooC .C .

4. Factors used to control Oxidation:4. Factors used to control Oxidation:a.a. Use dry powderUse dry powderb.b. Avoid direct exposure to Air.Avoid direct exposure to Air.c.c. Use antioxidant and chelating agentUse antioxidant and chelating agentd.d. Adjust pH.Adjust pH.e.e. Protect from light (amber glass)Protect from light (amber glass)Aromatic Water:Aromatic Water:1.1. A saturated aqueous solution of volatile oil A saturated aqueous solution of volatile oil

as peppermint or volatile substance as as peppermint or volatile substance as menthol.menthol.

2.2. Preparation:Preparation:11/24/2013 14Orientation Pharmacy part-2 Dr. Khairi M. Salem

. . PreparationPreparation::a.a. Distillation: Plant source (flowers) is mixed with Distillation: Plant source (flowers) is mixed with

water followed by steam distillation.water followed by steam distillation.b.b. Solution: agitation of volatile substance with water Solution: agitation of volatile substance with water

for ½ Hr. followed by filtration.for ½ Hr. followed by filtration.c.c. Dispersing agent: As solution, but in presence for a Dispersing agent: As solution, but in presence for a

dispersing agent (talc) to decrease mixing time.dispersing agent (talc) to decrease mixing time.d.d. Solublization: To use solubilizing agent for quick and Solublization: To use solubilizing agent for quick and

complete dissolution.complete dissolution.e.e. Dilution: to mix concentrated water or spirit with Dilution: to mix concentrated water or spirit with

water.water.3. Examples are : rose water, caraway water and cinnamon 3. Examples are : rose water, caraway water and cinnamon

waterwater4. Used as flavoring agent, addition of a salt as NaCl or 4. Used as flavoring agent, addition of a salt as NaCl or

KCl may lead to salting out, i.e. separation of volatile KCl may lead to salting out, i.e. separation of volatile oil.oil.

Solution: Solution: May be internal as syrups , drops and May be internal as syrups , drops and

suspensions or external as lotionssuspensions or external as lotions Spirits: Spirits: Alcoholic or hydro-alcoholic solutions of Alcoholic or hydro-alcoholic solutions of

volatile substances that contain 50-90 % alcohol. volatile substances that contain 50-90 % alcohol. By using high % of alcohol-insoluble material in By using high % of alcohol-insoluble material in solution. solution.

Tincture: Tincture: Alcoholic or hydro-alcoholic solution of Alcoholic or hydro-alcoholic solution of vegetable substances that contain around 20% vegetable substances that contain around 20% alcohol.alcohol.

Syrups: Syrups: oral liquid dosage form contain sugar as Sweeting agents.


Formulation:Formulation:a.a. Drug or drugs.Drug or drugs.b.b. Solvent (water).Solvent (water).c.c. Preservative: To prevent growth of microbes and as Preservative: To prevent growth of microbes and as

antioxidantantioxidantd.d. Flavoring agent ; to cover unsuitable taste as: Flavoring agent ; to cover unsuitable taste as:

peppermint, banana, lemon …etcpeppermint, banana, lemon …etce.e. Sweeting agent to improve the taste of solution as Sweeting agent to improve the taste of solution as

sugar, saccharin.sugar, saccharin.f. Coloring agent: of volatile substance with water for ½ f. Coloring agent: of volatile substance with water for ½

Hr. followed by filtration.Hr. followed by filtration.g. Sesiqutering agent: as ethylene diamine tetra a acetic g. Sesiqutering agent: as ethylene diamine tetra a acetic

acid (EDTA)acid (EDTA)h. Solubilizing agent: as surfactants used to solubilize h. Solubilizing agent: as surfactants used to solubilize

drugs. .drugs. .Suspension: Suspension: LDF consist of finely divided drug (s), LDF consist of finely divided drug (s),

which are insoluble in solvent (water)which are insoluble in solvent (water)Advantages:Advantages: To cover the bitter taste and avoid degradationTo cover the bitter taste and avoid degradation Sustaining the release of active ingredientsSustaining the release of active ingredients Improving the stability of the formulationImproving the stability of the formulationPrecautions: Precautions: Patient must shake the bottle before usePatient must shake the bottle before use Parenteral suspension are not allowed to be injected Parenteral suspension are not allowed to be injected

I.V I.V (avoiding Thrombophlebitis = (avoiding Thrombophlebitis = inflammation of a vein)Topical suspension are called Lotions e.g. Calamine lotions11/24/2013 16Orientation Pharmacy part-2 Dr. Khairi M. Salem

Formulation: The suspension should contain a suspending agent (hydrocolloids) which has the following properties :

Help the suspension of the particles, to avoid quick precipitation

Increase water viscosity Support growth of microorganism

Suspending agent (hydrocolloids) properties : Mostly anionic except methyl cellulose which

is neutral The anionic suspending agent are

incompatible with cationic drugs and agent. Support growth of microorganism Examples as: Acacia 35% dispersed in water,

Tragacanth 6%, methyl cellulose and sodium carboxymethyl cellulose (CMC).

Clays : other example of suspending agent which,

• Form gel like structureForm gel like structure• Anionic in natureAnionic in nature• Examples as: bentonite and veegum which Examples as: bentonite and veegum which

are silicates that are anionic in aqueous are silicates that are anionic in aqueous dispersion. dispersion.

Improve appearances for topical Improve appearances for topical preparations.preparations.11/24/2013 17Orientation Pharmacy part-2 Dr. Khairi M.

Salem

Emulsion: Emulsion: LDF consist of two phase LDF consist of two phase system in which one phase is oil system in which one phase is oil (internal) is dispersed in a second (internal) is dispersed in a second phase (external phase) as water phase (external phase) as water using emulsifying agent as gum or using emulsifying agent as gum or acacia called acacia called W/O or O/W W/O or O/W emulsionsemulsions

Purpose of emulsion:Purpose of emulsion: Increase drug solubilityIncrease drug solubility Increase drug stabilityIncrease drug stability Prolonged drug action ; increase Prolonged drug action ; increase

bioavailability as with I.M injectionbioavailability as with I.M injection Improve the taste.Improve the taste.Emulsifying agent : Emulsifying agent : are used to

lower the surface tension between oil and water, examples as;water, examples as;

Natural : acacia, gelatin and methyl Natural : acacia, gelatin and methyl cellulose .cellulose .

Synthetic agents : anionic as soaps Synthetic agents : anionic as soaps and cationic as benzalkonium and cationic as benzalkonium chloride or nonionic as polysorbate chloride or nonionic as polysorbate 80.80.


Oral Drops : These include: vitamin C,

Vitamin D, Multivitamin, cardiovascular and antihistaminic drops

They must supply with droppers to calculate the dose. Support growth of microorganism

Similar to syrups in formulation and production.

Accurate dose should be carefully measured. And the container should be closed after measuring the dose.

Oral Mixture: Oral Mixture: LDF consist of LDF consist of combination of more than combination of more than one drug, dissolved in water one drug, dissolved in water or aromatic.or aromatic.

These oral solutions used for These oral solutions used for many medical purposes as: many medical purposes as: hypnotichypnotic

( phenobarbitone sodium), ( phenobarbitone sodium), Decongestant (phenylephrine) Decongestant (phenylephrine) and antihistaminic as and antihistaminic as (chorpheiramine (chorpheiramine maleate)maleate)11/24/2013 19Orientation Pharmacy part-2 Dr. Khairi M.

Salem

External Solution:External Solution:Mouth washesMouth washes;; These are solutions used for cleaning and These are solutions used for cleaning and

disinfecting of the mouth and oral cavity.disinfecting of the mouth and oral cavity. Contain solvent as glycerin to dissolve active Contain solvent as glycerin to dissolve active

ingredients and prolog its action in mouthingredients and prolog its action in mouth Examples of disinfectant – detergent agents are Examples of disinfectant – detergent agents are

hexitidine , cetyl pyridium chloride etchexitidine , cetyl pyridium chloride etc Flavor is a must for mal-odor of mouth or Flavor is a must for mal-odor of mouth or

halitosis. Examples of flavor are clove, menthol, halitosis. Examples of flavor are clove, menthol, thyme oil.thyme oil.

Douches : Aqueous solutions directed into cavity or part of

the body for cleanings and antiseptic effects on eye, nose, pharynx, urethra or vagina .

Powder or tablet douches are mixed with warm water before use.

Gargles : Aqueous solution intended to come in contact

with throat for the longest time for antiseptic and cleaning actions.

Povidine-iodine, potassium chlorate, and potassium permanganate are used for treatment of bacterial phyaygities or tonalities

Must mixed with warm water before use. Must not swallowed. Frequent use 4-6 times

dailyNasal Drops: external aqueous solution applied

inn the nasal cavity as decongestant (phenylephrine) in common cold cases, stop hemorrhage ( Adrenaline)

Dropper is required for dosing11/24/2013 20Orientation Pharmacy part-2 Dr. Khairi M. Salem

Solid Dosage Forms:Powders:Powders: Limited number of pharmaceutical

powders e.g. talc or other cosmetic powders, the particle size of the powder should be suitable for the intended use.

GranulesGranules : Effervescent granules contain drug (s)

with sodium bicarbonate, citric acid, tartaric acid and sugar. When granules are mixed with water CO2 is evolved and covers the bitter taste.

Capsules:Capsules: A solid dosage form which can be classified

into: 1. Hard gelatin Capsule: in which a solid

powder or granules of drug are enclosed in a gelatin shell.

Preparation of Hard gelatin Capsule:Preparation of Hard gelatin Capsule: Include Preparing the formulation , Include Preparing the formulation ,

selecting the appropriate capsule, filling selecting the appropriate capsule, filling the capsule shells, and cleaning and the capsule shells, and cleaning and polishing of the filled capsule.polishing of the filled capsule.

Empty hard capsule shells are Empty hard capsule shells are made made fromfrom a mixture of gelatin, colorants and a mixture of gelatin, colorants and opacifying agent opacifying agent

as titanium dioxide.as titanium dioxide. Sizes of capsules are available in verity Sizes of capsules are available in verity

of sizes ranged from 000 to 5 (600 to 30 of sizes ranged from 000 to 5 (600 to 30 mg.).mg.).11/24/2013 21Orientation Pharmacy part-2 Dr. Khairi M.

Salem

2. Soft gelatin Capsule: (soft gels) in which semisolid or oily liquids are closed inside completely sealed gelatin shell.

Properties of CapsulesProperties of Capsules : elegant shape, easily : elegant shape, easily swallowed, mask the bad taste and odor swallowed, mask the bad taste and odor ensure stability and rapid absorption.ensure stability and rapid absorption.

Soft gels are more efficient in these characters.Soft gels are more efficient in these characters. Pastilles:Pastilles: These are not swallowed but kept in mouth These are not swallowed but kept in mouth

until dissolved slowly to produce their action in until dissolved slowly to produce their action in buccal cavity.buccal cavity.

Their taste and odour must be acceptable.Their taste and odour must be acceptable. They contain agents allowing for slow They contain agents allowing for slow

dissolution e.g. gelatin.dissolution e.g. gelatin. They are used for antiseptic, aesthetic or anti-They are used for antiseptic, aesthetic or anti-

inflammatory effects.inflammatory effects.

Tablet: Tablet: very common and most popular dosage form very common and most popular dosage form

examples are: examples are: compressed, Multiple compressed, Multiple compressed, Repeat –action, Delayed compressed, Repeat –action, Delayed action or Sustained release, Flash, Coated, action or Sustained release, Flash, Coated, sublingual, buccal and Effervescent sublingual, buccal and Effervescent


Advantages: Produced easily (Complete automation to

produce millions of tablets /day) Very stable( No water , coated) .Very stable( No water , coated) . Mask the unpleasant taste (film coated)Mask the unpleasant taste (film coated) Avoid irritant action in stomach (enteric Avoid irritant action in stomach (enteric

coated tablet) dissolve in duodenum not in coated tablet) dissolve in duodenum not in stomach.stomach.

Control release (sustained release tablet)Control release (sustained release tablet) Unit Dosing and convenient for storage and Unit Dosing and convenient for storage and

transport.transport. It has various shapes ( round, oval, caplet .. It has various shapes ( round, oval, caplet ..

etc.)etc.)

Disadvantages: Disadvantages: Possible variability in dissolution.Possible variability in dissolution. Possible degradationPossible degradation

Characteristic of an ideal Tablet:Characteristic of an ideal Tablet: Free from defects and contain the labelled Free from defects and contain the labelled

dose.dose. Stands mechanical stress during transport.Stands mechanical stress during transport. Stable and achieves the required absorptionStable and achieves the required absorption11/24/2013 23Orientation Pharmacy part-2 Dr. Khairi M.

Salem

Formulation: Active ingredient (s) Diluents:Diluents: filling agent used to make the required size as filling agent used to make the required size as

lactose. lactose. Binder:Binder: used to promote granulations and compact of used to promote granulations and compact of

granules as CMC.granules as CMC. Distentegrant:Distentegrant: agent used to facilitate disintegration as agent used to facilitate disintegration as

starch.starch. Lubricant: reduce the tablet and the die of tablet machine Lubricant: reduce the tablet and the die of tablet machine

as magnesium stearate. as magnesium stearate. Glidant: Promote the flow of the granules.Glidant: Promote the flow of the granules. Other agents as coloring, flavoring, dissolution control Other agents as coloring, flavoring, dissolution control

coating agents.coating agents.

Semi- Sold Dosage FormsSemi- Sold Dosage Forms: : 1. 1. Ointments:Ointments: Semisolid preparations intended for external Semisolid preparations intended for external

use, applied as: use, applied as: Emollient to render skin softEmollient to render skin soft Protection from sun, and chemicals.Protection from sun, and chemicals. Treatment of skin diseases.Treatment of skin diseases. Vehicle for medicationsVehicle for medications


Formulation: Active ingredient (s) Ointment base as: Ointment base as: 1. Oleaginous base (anhydrous (anhydrous

and insoluble in water base). and insoluble in water base). 2. Absorption base (can (can absorb water) . absorb water) . 3. Emulsion base as w/o or o/w as w/o or o/w emulsions and emulsions and 4. water soluble base are anhydrous are anhydrous and water soluble base. and water soluble base.

Advantages: Direct targeting of medicationsDirect targeting of medications.. Ease of administration. Ease of administration. Various functions.Various functions.2. Suppositories: Solid or Semi- Sold Dosage Form intended to be Solid or Semi- Sold Dosage Form intended to be

inserted ininserted in• Rectum, rectal Supp. A bullet like shape for adults Rectum, rectal Supp. A bullet like shape for adults

2g. For children smaller size.2g. For children smaller size.• Vagina are oval shape weigh around 5 gm. andVagina are oval shape weigh around 5 gm. and• Urethra : Typically long , around 60 mm. Long and 4-Urethra : Typically long , around 60 mm. Long and 4-

5 mm in diameter. 5 mm in diameter. Formulation: Active ingredient (s) + Suppository base Active ingredient (s) + Suppository base

as cocoa butter (theobroma oil, M. range 33-35as cocoa butter (theobroma oil, M. range 33-35oC) or C) or other combinations of fat and waxes bases. other combinations of fat and waxes bases.

Advantages: Needed for Quick evacuation of stool.Needed for Quick evacuation of stool. Direct targeting of drugs as in Haemorrhoids disease.Direct targeting of drugs as in Haemorrhoids disease. More suitable for children and used for patient More suitable for children and used for patient

cannot swallow.cannot swallow. Various functions and have different shapes and sizes.Various functions and have different shapes and sizes.11/24/2013 25Orientation Pharmacy part-2 Dr. Khairi M. Salem

Pharmacy Education

• Over the past four decades there has been a trend for pharmacy practice to move away from its original focus on medicine supply towards a more inclusive focus on patient care.

• The role of the pharmacist has evolved from that of a compounded and supplier of pharmaceutical products towards that of a provider of services and information and ultimately that of a provider of patient care. Increasingly, the pharmacist’s task is to ensure that a patient’s

• drug therapy is appropriately indicated, the most effective available, the safest possible, and convenient for the patient. By taking direct responsibility for individual patient’s medicine-related needs, pharmacists can make a unique contribution to the outcome of drug therapy and to their patients’ quality of life. The new approach has been given the name

• pharmaceutical care. The most generally accepted definition of this new approach is:" Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life”.

• A growing number of pharmacy education programs prepare students for nationally certified pharmacy certificates. These health care certificates authorize pharmacists to directly oversee patients' drug therapy in place of or in addition to a primary care physician.


A change in pharmacy education and a new learning approach

• Pharmacists stand at the interface between research and development, manufacturer, prescriber, patient and the medicine itself. WHO has called for greater involvement of pharmacists in the general health care system and wider use of their broad academic background.

• In its statement of policy, FIP says that the changes in the pharmacist’s role must be reflected in the basic and continuing education of pharmacists,40 with a greater focus on student learning. The new paradigm for pharmacy requires that pharmacists are far more than experts in pharmaceutical chemistry and pharmaceutics. They have to understand and apply the principles behind all the activities necessary to manage drug therapy. In 1999, the European Association of Faculties of Pharmacy (EAFP) proposed a shift during the pharmacy study program from laboratory-based sciences to practice and clinical sciences

• The movement towards the patient care approach has occurred to varying degrees in some countries such as the UK and the USA. It encompasses care in its widest application, i.e., the opportunity for pharmacists to change and improve patient outcomes as integral, active members of the patient care team


Pharmacy education : College of Pharmacy

Mission:• The College serves UAE and the region by preparing outstanding,

highly competent and motivated pharmacists to meet the health highly competent and motivated pharmacists to meet the health care needs of the society, improve delivery of essential pharmacy care needs of the society, improve delivery of essential pharmacy servicesservices, ensure human health through optimization of using effective, safe and economic drug therapy and enhance pharmaceutical industry, especially in areas of continued-education, services and researches. The college serves the students by offering an educational program based on best pharmacy practice, professional practice experience and educational environment aligned with Needs of the society.

College Goals:• 1. Provide students a highly advanced educational program which

offers knowledge in pharmacy practice and pharmaceutical industry.

• 2. Prepare pharmacists with pharmacy practice and pharmaceutical industry skills that ensure competency and superiority.

• 3. Prepare pharmacists with professional skills that optimize interaction with health care providers, patients and society.

• 4. Prepare pharmacists capable of understanding the most advanced technologies.

Graduation RequirementsGraduation Requirements• 20

• 33


Thank YouThank You

Khairi M. Salem. B.Pharm. PhDKhairi M. Salem. B.Pharm. PhD

Associate Prof. in pharmaceutical Associate Prof. in pharmaceutical analysisanalysis





Documents

Orientation to Pharmacy 2014-Part 2