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Al-Ain University of Science and

Technology
College of Pharmacy
Part 2-

Orientation to Pharmacy
Dr. Khairi M. Salem 2014-2

11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

Chapter 5,
Ethics in Pharmacy

A group of behavior 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: a set of standards , rules , guidelines and


values that govern the profession of pharmacy.

A pharmacist respect the covenantal relationship


between the patient and pharmacist.

A pharmacist promotes the good of every patient in


caring and confidential.

A pharmacist respects the autonomy and dignity of each


patient.

A pharmacist acts with honesty and integrity in


professional relationships.

A pharmacist maintains professional competence.

A pharmacist serves individual community and social


needs

A pharmacist seeks justice in distribution of health


recourses.
11/24/2013

Orientation 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:
1. According to physical state:
A.
Solid as Granules , Capsules and Tablets
B.
Liquids as Solutions, Syrup, lotions, drops
C.
Gas: Aerosols
2. According to the route of administration:
A.
Oral: oral powder, tablet, capsules, Syrups and oral
drops
B.
Topical: Ointment, creams, lotions
C.
Rectal : Enemas, Suppositories
D.
Parenteral: Intravenous (I.V), Intramuscular (I.M),
E.
Interaperitoneal (IP) and Subcutaneous (S.C)
F.
Ophthalmic preparations: Drops, Ointments and
Creams,
G.
Nasal : drops
Orientation Pharmacy part-2 Dr. Khairi M.
11/24/2013

Salem

Why drug delivery System :


To control the Dosing
Unit Dose Product : Tablet, Capsule, Suppositories
and ampoules
B.
Multiple dose product: syrup
C.
Unit dose product control dosing much butter
2. To modify the dissolution in GIT
3. To modify taste and order of drugs
4. To improve stability of unstable drugs
1.
A.

The requirements drug delivery System:


The Why drug delivery System must be:
1. Convenient for patient: easily swallowed, no
bitter taste, good odor, not irritant to
stomach
2. It must be stable: light, humidity and
temperature
3. It must be therapeutically effective
4. It could be identified
5. It must afford several doses, economic and
elegant package
11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M. Salem

11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

Assessment of the quality of the


product
1.
2.
3.
4.
5.
6.

Stability of the product: Solid< semisolid <liquids


Dissolution and Absorption: I.V. Solutions <oral
liquids <suspension <capsules < tablets.
Manufacturing: Tablet < Parenteral
Ease of use: Tablet < Parenteral
Proper dosing : Tablet < syrup
Homogeneity: Liquid Dosage Forms < Tablet.

Liquid Dosage Forms:

Formulation: important role of industrial pharmacist,


which carried out in R&D , it means the selection of
the additives used to change the active ingredient to
the required dosage form.
1.
For liquid dosage form there is a need for a solvent
to dissolve or suspend the active ingredient.
2.
A flavoring agent is used to cover unpleasant odor
3.
A sweating agent is used to cover unpleasant taste
4.
A coloring agent is used to give attractive color
5.
A preservative to avoid microbial growth,
6.
A stabilizer to ensure and enhance stability

11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

Advantages:
1. Homogenous in content i.e. no different in dosing.
2. Easy for administration i.e. for children and in sore throat
3. No need for disintegration as tablet or dissolution as tablet
and capsule
4. Less irritant for stomach.
Disadvantages:
1. Taste and odor problem.
2. Less stable. Needs preservative to avoid microbial growth.
3. Less stable due to the water presence, needs antioxidant and
colored container to avoid direct effect of sunlight.
4. Heavy bottles difficult to carry and storage.
5. Parenteral or eye drops require sterility
6. Improper dosing , since they are multi dose form

11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

Solvents:
Water
Advantages:
1.
Cheep.
2.
Wide rang of solubility
3.
Inert: no chemical or pharmacological
action
4.
Colorless, odorless, tasteless and neutral
Disadvantages:
1.
A medium for degradation process.
2.
Dissolve sugars and proteins ( cause
bacterial growth & fermentation)
3.
May contain minerals or bacteria
Types of water: 1. Tap water:
A. It contain minerals and microbes
B. Boiled then cold water may show
microbial growth
C. Not permitted to use in Liquid dosage
forms
11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

Purified Water:
A. Water free from total solids >10 ppm
B. Prepared by distillation or ion exchange
resins
C. Ion Exchange Resins are used to remove
minerals dissolved in water.

11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M.


Salem

Water for injection:


A. Free from Bacteria.
B. Free from Pyrogen
C. Free from minerals, total solids >10 ppm.
D.
E.

Used for sterile products


Sterile water may be found up into 1 liter
container.

4. Bacteriostatic Water for injection:


A. All the property listed under water for
injection.
B. Contains a bacteriostatic agent at specific
concentration.
C. Used for vials or multiple dose products.
D.

Volumes must not exceed 30 ml.

D.

Used for sterile products

1.

More specific for dissolving certain materials ( not


dissolve sugars, gums and proteins.
Kills Microbes
Used to extract Alkaloids and glycosides

Ethyl Alcohol:
A. Free from Bacteria.
B. Free from Pyrogen
C. Free from minerals, total solids >10 ppm.
Ethyl Alcohol; Advantages :
2.
3.

Disadvantages: Volatile, Affects CNS, Liver, GIT


etc ( the solvent not accepted by Islam efforts
should be carried out to replaced )

11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M. Salem

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Glycerol; Advantages :
1.
Not volatile.
2.
Not toxic1
Disadvantages:
1.
Hygroscopic
2.
Dissolve gums, albumins and tannins
Co-Solvency:
1.
Means the use of 2 solvents to enhance the solubility of certain reagent.
2.
Examples as : Water/ Glycerol and Ethanol / Water
Hydrotrophy: The use of certain solutes ( sodium benzoate or sodium
salicylate to dissolve other material as cholesterol.
Soulbilization:
1.
Vitamin D is insoluble in water, used as aqueous drops for children.
2.
It is required in the form of aqueous drops of children
3.
To enhance its solubility Soulbilization is required.
4.
This involve the using of surfactant SLS, polysorbate 80 to solubilize the
5.
A specific concentration is used.
6.
Improve both stability and stability and bioavailability of drugs.

11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M. Salem

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Flavoring Agents:
1.
Overcome the problems of the drug taste..
2.
Bitter taste as drotaverine HCl (antitussive) is covered by
Cocoa
3.
Acid taste is covered by citrus, cinnamon
4.
Flavors are either soluble or insoluble in water
5.
Some flavors are used to expel gases in flatulence or improve
digestions
Avoid the crystals building in kidney and as mild antibacterial
agents
Sweeting Agents:
1.
Sucrose:
a.
Favor the growth of microbes at low concentration.
b.
Sucrose is soluble in water 2:1
c.
The concentration of its solution in water is 66%
d.
At 66% it prevent s the growth of micro-organisms
e.
Contraindicated in diabetes and obesity
2. Saccharin:
a. It is synthetic , 500 sweeter than sucrose, used for diabetes, not
carcinogenic in proper dose
3. Aspartame
a.
It is 120-280 sweeter than sucrose.
b.
Consists of two amino acid molecules.
c.
It decomposes in presence of water ( provided in tablet ( solid
form

11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M.


Salem

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Coloring Agents: To select a coloring agent:


1.
Only use colors approved by FDA
2.
Colors are used for psychological factors as
antidepressants, confidence as syrup or for
identification as tablets and capsule
3.
Natural colors (caramel) are better than
synthetic ones (tartrazines). Tartrazines is not
used due to allergy
4.
Insure stability of the color
Preservative:
Agents used to prevent the growth of microbes
found in or added to the container during the
use of medicine.
The preservative should have the following
requirements:

Safe, Soluble and Stable

Compatible with all ingredients.

Dont interact with container or cover


Examples of Preservatives:

Benzoic Acid 0.1-0.2% ,

Sodium benzoate 0.1-0.2% ,

Methyl Paraben & Propyl Paraben 0.1-0.2%

Phenyl mercuric nitrate 0.002-0.01%


11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M. Salem

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Stabilizers: Agents used to enhance stability:


1.
Degradation occurs due to:
a.
Oxidation( in presence of water, O2 or Air)
b.
Hydrolysis ( in presence of water at specific pH)
2. Factors favoring degradation (light (sun), Heat
(hot weather) catalyst)
3. Factors used to control Hydrolysis:
a.
Use of dry powder followed by reconstitution
just before use.
b.
Use solvents such as glycerin and propylene
glycol.
c.
Formulate at pH at which least degradation
takes place.
d.
Store at low temp. not more than 25 oC .
4. Factors used to control Oxidation:
a.
Use dry powder
b.
Avoid direct exposure to Air.
c.
Use antioxidant and chelating agent
d.
Adjust pH.
e.
Protect from light (amber glass)
Aromatic Water:
1.
A saturated aqueous solution of volatile oil as
peppermint or volatile substance as menthol.
2.
Preparation:
Orientation Pharmacy part-2 Dr. Khairi M.

11/24/2013

Salem

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. Preparation:
a.

Distillation: Plant source (flowers) is mixed with


water followed by steam distillation.
b.
Solution: agitation of volatile substance with water for
Hr. followed by filtration.
c.
Dispersing agent: As solution, but in presence for a
dispersing agent (talc) to decrease mixing time.
d.
Solublization: To use solubilizing agent for quick and
complete dissolution.
e.
Dilution: to mix concentrated water or spirit with
water.
3. Examples are : rose water, caraway water and cinnamon
water
4. Used as flavoring agent, addition of a salt as NaCl or KCl
may lead to salting out, i.e. separation of volatile oil.

Solution: May be internal as syrups , drops and


suspensions or external as lotions

Spirits: Alcoholic or hydro-alcoholic solutions of


volatile substances that contain 50-90 % alcohol.
By using high % of alcohol-insoluble material in
solution.
Tincture: Alcoholic or hydro-alcoholic solution of
vegetable substances that contain around 20%
alcohol.
Syrups: oral liquid dosage form contain sugar as
Sweeting agents.
11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M.


Salem

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Formulation:
a.
Drug or drugs.
b.
Solvent (water).
c.
Preservative: To prevent growth of microbes and as
antioxidant
d.
Flavoring agent ; to cover unsuitable taste as: peppermint,
banana, lemon etc
e.
Sweeting agent to improve the taste of solution as sugar,
saccharin.
f. Coloring agent: of volatile substance with water for Hr.
followed by filtration.
g. Sesiqutering agent: as ethylene diamine tetra a acetic acid
(EDTA)
h. Solubilizing agent: as surfactants used to solubilize drugs. .
Suspension: LDF consist of finely divided drug (s),
which are insoluble in solvent (water)
Advantages:

To cover the bitter taste and avoid degradation

Sustaining the release of active ingredients

Improving the stability of the formulation


Precautions:

Patient must shake the bottle before use

Parenteral suspension are not allowed to be injected I.V

(avoiding Thrombophlebitis = inflammation of a vein)


Topical suspension are called Lotions e.g. Calamine lotions

11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M. Salem

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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 structure
Anionic in nature
Examples as: bentonite and veegum which are
silicates that are anionic in aqueous dispersion.
Improve appearances
for topical
preparations.
Orientation
Pharmacy
part-2 Dr.

11/24/2013

Khairi M. Salem

17

Emulsion: LDF consist of two phase


system in which one phase is oil
(internal) is dispersed in a second phase
(external phase) as water using
emulsifying agent as gum or acacia called
W/O or O/W emulsions
Purpose of emulsion:
Increase drug solubility
Increase drug stability
Prolonged drug action ; increase
bioavailability as with I.M injection
Improve the taste.
Emulsifying agent : are used to lower the
surface tension between oil and water,
examples as;
Natural : acacia, gelatin and methyl
cellulose .
Synthetic agents : anionic as soaps and
cationic as benzalkonium chloride or
nonionic as polysorbate 80.

11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

18

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: LDF consist of


combination of more than one
drug, dissolved in water or
aromatic.
These oral solutions used for
many medical purposes as:
hypnotic
( phenobarbitone sodium),
Decongestant (phenylephrine)
and antihistaminic as
(chorpheiramine maleate)
11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

19

External Solution:
Mouth washes;
These are solutions used for cleaning and disinfecting
of the mouth and oral cavity.
Contain solvent as glycerin to dissolve active
ingredients and prolog its action in mouth
Examples of disinfectant detergent agents are
hexitidine , cetyl pyridium chloride etc
Flavor is a must for mal-odor of mouth or halitosis.
Examples of flavor are clove, menthol, 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 daily
Nasal Drops: external aqueous solution applied inn the
nasal cavity as decongestant (phenylephrine) in
common cold cases, stop hemorrhage ( Adrenaline)
Dropper is required for dosing
11/24/2013

Orientation Pharmacy part-2 Dr. Khairi M. Salem

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Solid Dosage Forms:

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.
Granules :
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:
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:
Include Preparing the formulation , selecting
the appropriate capsule, filling the capsule
shells, and cleaning and polishing of the filled
capsule.
Empty hard capsule shells are made from a
mixture of gelatin, colorants and opacifying
agent
as titanium dioxide.
Sizes of capsules are available in verity of sizes
ranged from 000 to 5 (600 to 30 mg.).
Orientation Pharmacy part-2 Dr.
11/24/2013

Khairi M. Salem

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2. Soft gelatin Capsule: (soft gels) in which semisolid or


oily liquids are closed inside completely sealed gelatin
shell.
Properties of Capsules : elegant shape, easily
swallowed, mask the bad taste and odor ensure
stability and rapid absorption.
Soft gels are more efficient in these characters.
Pastilles:
These are not swallowed but kept in mouth until
dissolved slowly to produce their action in buccal
cavity.
Their taste and odour must be acceptable.
They contain agents allowing for slow dissolution e.g.
gelatin.
They are used for antiseptic, aesthetic or antiinflammatory effects.
Tablet:
very common and most popular dosage form examples
are: compressed, Multiple compressed, Repeat
action, Delayed action or Sustained release,
Flash, Coated, sublingual, buccal and
Effervescent
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Orientation Pharmacy part-2 Dr.


Khairi M. Salem

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Advantages:
Produced easily (Complete automation to
produce millions of tablets /day)
Very stable( No water , coated) .
Mask the unpleasant taste (film coated)
Avoid irritant action in stomach (enteric coated
tablet) dissolve in duodenum not in stomach.
Control release (sustained release tablet)
Unit Dosing and convenient for storage and
transport.
It has various shapes ( round, oval, caplet .. etc.)
Disadvantages:
Possible variability in dissolution.
Possible degradation
Characteristic of an ideal Tablet:
Free from defects and contain the labelled dose.
Stands mechanical stress during transport.
Stable and achieves the required absorption
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Orientation Pharmacy part-2 Dr.


Khairi M. Salem

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Formulation:
Active ingredient (s)
Diluents: filling agent used to make the required size as lactose.
Binder: used to promote granulations and compact of granules as
CMC.
Distentegrant: agent used to facilitate disintegration as starch.
Lubricant: reduce the tablet and the die of tablet machine as
magnesium stearate.
Glidant: Promote the flow of the granules.
Other agents as coloring, flavoring, dissolution control coating
agents.
Semi- Sold Dosage Forms:
1. Ointments: Semisolid preparations intended for external use,
applied as:
Emollient to render skin soft
Protection from sun, and chemicals.
Treatment of skin diseases.
Vehicle for medications

11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

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Formulation:

Active ingredient (s)


Ointment base as: 1. Oleaginous base (anhydrous and
insoluble in water base). 2. Absorption base (can absorb water)
. 3. Emulsion base as w/o or o/w emulsions and 4. water
soluble base are anhydrous and water soluble base.
Advantages:
Direct targeting of medications.
Ease of administration.
Various functions.
2. Suppositories:
Solid or Semi- Sold Dosage Form intended to be inserted in
Rectum, rectal Supp. A bullet like shape for adults 2g. For
children smaller size.
Vagina are oval shape weigh around 5 gm. and
Urethra : Typically long , around 60 mm. Long and 4-5 mm in
diameter.
Formulation: Active ingredient (s) + Suppository base as cocoa
butter (theobroma oil, M. range 33-35oC) or other
combinations of fat and waxes bases.
Advantages:
Needed for Quick evacuation of stool.
Direct targeting of drugs as in Haemorrhoids disease.
More suitable for children and used for patient cannot
swallow.
Various functions andOrientation
have different
shapes and sizes.
11/24/2013
Pharmacy part-2 Dr. Khairi M. Salem
25

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 pharmacists task is
to ensure that a patients
drug therapy is appropriately indicated, the most effective
available, the safest possible, and convenient for the patient. By
taking direct responsibility for individual patients medicinerelated 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 patients 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.

11/24/2013

Orientation Pharmacy part-2 Dr.


Khairi M. Salem

26

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
pharmacists 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
11/24/2013

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Khairi M. Salem

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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 care needs of the
society, improve delivery of essential pharmacy services,
services 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 Requirements
20

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Thank You
Khairi M. Salem. B.Pharm. PhD
Associate Prof. in pharmaceutical
analysis
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