Basic principles of compounding and dispensing MANIK

Basic principles of compounding and dispensing: Containers and closures for dispensed products
Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.) Page 1
manikrupharmacy@gmail.com; Lecturer; Department of Pharmacy; Primeasia University.
Packaging
Packaging is the process by which the pharmaceuticals are suitably packed so that they should retain their
therapeutic effectiveness from the time of their packaging till they are consumed.
It is the art and science which involves preparing the articles for transport, storage, display and use.
Container
A container may be defined as a device in which the drug is enclosed and is in direct contact with the
drug.
Closures
A closure is a device which seals the container to exclude oxygen, carbon-dioxide, moisture,
micro-organisms and prevent the loss of volatile substances.
It also prevents the loss of medicament during transport and handling.
The qualities of good containers and closures
The good packaging materials i.e. the containers and closures must meet the following criteria.
(Ideal properties of containers and closures)
1. The material must give the container sufficient strength to withstand the extremes of
temperature and pressure as well as to withstand handling while empty, while filling, closing,
sterilizing, labelling, transport, storage and use by the consumer.
2. The material should be impervious to any possible contaminants; for example solids, liquids,
gases vapours or microorganisms.
3. It should not interact with the contents. This includes migration, absorption, adsorption or
extraction. e.g. Absorption of water from creams into cardboard boxes.
4. It should protect the contents from the loss of product due to leakage, spillage or permeation.
5. The container must not impart its own colour, test or odour to the preparation.
6. They must be FDA (Food & Drug Administration) approved.
7. They must meet applicable tamper-resistance requirements.
8. They must be adaptable to commonly employed high-speed packaging equipment.
9. Must be cheap and economical i.e. they must have reasonable cost in relation to the cost of the
product.
10. They must be convenient and easy to use by the patient.
11. They must be non-toxic and biodegradable.
12. The container and closure must not react either with each other or with the preparation.
13. Apart from all these a container and closure should be attractive in appearance and must have
sale promotion and marketing value.
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Types of Container
The containers can be classified into the following types.
1. Well closed containers: A well closed containers is used to protect the preparation from
contamination by extraneous solids to prevent the loss of potency of active constituents and to
prevent the loss of contents during transport, storage and handling.
2. Air-tight containers: Air-tight containers are used to protect the containers from atmospheric
contamination of liquids, solids or vapors. They prevent the drugs due to efflorescence,
deliquescence or evaporation.
3. Hermetically-Sealed containers: Hermetically sealed container is that which does not allow
the air or other gases to pass through it. They are generally used for injectables.
4. Light-resistant containers: Light resistant containers are used to protect the drugs which
undergo decomposition in the presence of light. For e.g .Amber colored glass or opaque glass.
5. Single dose containers: They are used to supply only one dose of the medicament. They are
sealed in such a way that the contents cannot be removed without removing the seal; the
contents so removed are consumed immediately. e,g. ampoules.
6. Multi dose containers: A multi dose container should hold a number of doses. It is sealed in
such a way that success doses can be withdrawn easily without changing the strength, quality or
purity of the remaining contents e.g multi dose vials.
7. Aerosol containers: Containers for aerosols must be strong enough to withstand the pressure
evolved inside the container at the time of use of preparation.
Materials used for the making of containers
I. Glass
II. Metals
III. Rubbers
IV. Plastics
V. Fibrous material
VI. Films, foils and laminates
Glass
Glass has been widely used as a drug packaging material. Glass is composed of sand, soda ash,
limestone,& cullet. Si, Al, Na, K, Ca, Mg, Zn & Ba are generally used into preparation of glass.
Advantages
1. They are hygienic and suitable for sterilization
2. They are relatively non reactive ( depending on the grade chosen)
3. They can be used on high speed packaging lines
4. They can be easily labeled.
5. They are transparent.
6. They are available in various shapes and sizes.
7. They can withstand the variation in temperature and pressure during sterilization.
8. They are economical and easily available.
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9. They can protect the photosensitive medicaments from light during their storage.
10. They are neutral after proper treatment.
11. They are impermeable to atmospheric gases and moisture.
12. They have good protection power.
13. They do not deteriorate with age.
14. They can be sealed hermetically or by removable closures.
Disadvantages
1. It is relatively heavy
2. Glass is fragile so easily broken.
3. Release alkali to aqueous preparation.
4. They may crack when subjected to sudden changes of temperature.
5. Some containers can impart alkalinity and insoluble flakes to the formulations.
Flaking
During flaking the alkali is extracted from the surface of the glass containers and a silica rich layer is
formed which sometimes gets detached from the surface and can be seen in the contents in the form of
shining flakes.
Fig; Flacking Fig: Weathering
Weathering
Weathering is a common problem with glass containers in which sometimes moisture condensed on the
surface of glass container, can extract some weakly bonded alkali, leaving behind a white deposit of
alkali carbonate.
Types of glass
1. Type I ( Neutral or Borosilicate Glass)
2. Type II ( Treated Soda-lime glass)
3. Type III ( Soda-lime glass)
4. Type IV- General Purpose soda lime glass
5. NP—soda glass (non parenteral usage)
6. Colored glass
7. Neutral glass
1. Type I-Borosilicate glass: Highly resistant and chemically inert glass. Alkali’s and earth cations of glass are replaced by boron
and/or aluminum and zinc. These are used to contain strong acids and alkalis.
2. Type 2-Treated soda-lime glass: These are more chemically inert than Type I glass. The glass surface is de-alkalized by “Sulfur
treatment” which prevents blooming/weathering from bottles.
3. Type III- Regular soda lime glass: Untreated soda lime glass with average chemical resistance.
4. Type IV- General Purpose soda lime glass: Glass is not used for parenterals, used only for products intended to be used orally or
topically.
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Package type Type of formulation can be packed
Minimum quality of glass that
can be used
Ampoule
Aqueous Injectables of Any pH Type I
Aqueous Injectables of pH Less Than 7 Type II
Non-Aqueous Injectables Type III
Vial
Aqueous Injectables of Any pH Type I
Aqueous Injectables of pH Less Than 7 Type II
Non-Aqueous Injectables Type III
Dry Powders For Parenteral Use
(Need To Be Reconstituted Before Use)
Type IV
Bottles
and
Jars
Tablets, Capsules, Oral Solids & Other Solids For
Reconstitution
Type IV
Oral Liquids (Solutions, Suspensions, Emulsions) Type IV
Nasal & Ear Drops Type IV
Certain Types Of External Semisolids
(Rubeficients, Local Irritants)
Type IV
Blood & Related Products Type I
Dropper Auxiliary Packaging Device With Certain Kind Of Products Type IV
Aerosol container
Aerosol product
( solution, suspension, emulsion or semisolid type)
Type I
METALS
Metals are used for construction of containers. The metals commonly used for this purpose are
aluminium, tin plated steel, stainless steel, tin and lead
Advantages:
1. They are sturdy. (
2. They are impermeable to light, moisture and gases.
3. They can be made into rigid unbreakable containers by impact extrusion.
4. They are light in weight as compared to glass containers.
5. Labels can be printed directly on to their surface.
Disadvantages:
1. They are expensive.
2. They react with certain chemicals
3. They may shed metal particles into the pharmaceutical product.
COLLAPSIBLE TUBES METAL
• The collapsible metal tube is an attractive container that permits controlled amounts to be
dispensed easily, with good enclosure, and adequate protection of the product.
• It is light in weight and unbreakable and lends itself to high speed automatic filling operations.
• Most commonly used are tin, aluminium and lead.
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Tin:
Tin containers are preferred for food, pharmaceuticals and any product for which purity is considered.
Tin is the most chemically inert of all collapsible metal tubes.
Aluminium:
Aluminium tubes offer significant savings in product shipping costs because of their light weight.
They are attractive in nature
Lead:
Lead has the lowest cost of all tube metals and is widely used for non food products such as adhesives,
inks, paints and lubricants.
Lead should never be used alone for anything taken internally because of the risk lead poison.
With internal linings, lead tubes are used for products such as chloride tooth paste.
PLASTIC
Plastics may be defined as any group of substances, of natural or synthetic origins, consisting chiefly of
polymers of high molecular weight that can be moulded into a shape or form by heat and pressure.
Advantages
1. They are light in weight than glass and can be handled easily.
2. They are poor conductor of heat.
3. They have sufficient mechanical strength.
4. They can be transported easily.
5. Extremely resistant to breakage
6. They are available in various shapes and sizes.
7. They are resistant to inorganic chemicals.
8. They have good protection power.
9. Flexible
10. Variety of sizes and shapes
11. Essentially chemically inert, strong, rigid Safety use, high quality,
various designs
Disadvantages
1. Absorption permeable to moisture
2. Poor printing, thermostatic charge
3. They are permeable to water vapor and atmosphere gases.
4. They cannot withstand heat without softening or distorting( ,)
5. They may interact with certain chemical to cause softening or distortion.
6. They may absorb chemical substances, such as preservatives for solution.
Classes of plastics:
There are two classes of plastics, reflecting the behavior with respect to individual or repeated exposure
to heating and cooling.
 Thermoplastics
• Capable of being shaped after initial heating and solidifying by cooling.
• Resistant to breakage and cheap to produce and providing the right plastics are chosen will
provide the necessary protection of the product in an attractive containers.
• E.g. Polystyrene, polyethylene and polyvinyl chloride.
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 Thermosets
• They need heat for processing into a permanent shape. During heating such materials form
permanent crosslinks between the linear chains, resulting in solidification and loss of plastic flow.
• E.g. Phenolic, urea and melamine are representative of thermosets.
Types of Plastics
Poly ethylene:
This is used as high and low density polyethylene.
Low density polyethylene (LDPE) is preferred plastic for squeeze bottles.
High density poly ethylene (HDPE) is less permeable to gases and more resistant to oils, chemicals and
solvents.
It is widely used in bottles for solid dosage forms.
Polyvinylchloride (PVC): Used as rigid packaging material and main component of intravenous bags.
Poly Propylene: It has good resistance to cracking when flexed. Suitable for use in closures, tablet
containers and intravenous bottles.
Polystyrene: It is also used for jars for ointments and creams with low water content.
FIBROUS MATERIALS
 The fibrous materials are the important part of pharmaceutical packaging.
 Fibrous materials include: Papers, Labels, Cartons, Bags, Outers, Trays For Shrink Wraps, Layer
Boards On Pallets, etc.
The Applications as well as Advantages of Cartons include:
 Increases display area
 Provides better stacking for display of stock items
 Assembles leaflets
 Provides physical protection especially to items like metal collapsible tubes.
 Fiberboard outers either as solid or corrugated board also find substantial application for
bulk shipments.
Regenerated cellulose film, trade names Cellophane & Rayophane, is used for either individual cartons or
to assemble a no. of cartons.
CLOSURES
Closures are the devices by means of which containers can be opened and closed.
Proper closing of the container is necessary because
– It prevents loss of material by spilling or volatilization.
– It avoids contamination of the product from dirt, microorganisms or insects.
– It prevents deterioration of the product from the effect of the environment
such as moisture, oxygen or carbon dioxide.
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Material used for closures
The closures for containers meant for storage of pharmaceutical products are generally made from the
following basic materials.
 Cork
 Glass
 Plastic
 Metal
 Rubber
• Cork: Cork is essentially a wood obtained from the bark of oak tree. It is used for the
manufacture of stoppers for narrow mouth bottles.
Fig: Cork
• Glass: As compared to cork glass is an ideal material for stoppers but
they do not provide leak proof closure as well as can easily slip out of the
neck of the closure during transport and handling.
• Plastic: As compared to cork, glass, rubber and metal Plastic closures are
becoming popular day by day as they are unbreakable, light in weight and can be
easily molded into various shapes and sizes.
• Metal: Tin plate and aluminum are mostly commonly used for the manufacture of
closures but aluminum is mostly used for this purpose.
RUBBERS (Elastomers):
Excellent material for forming seals, used to form closures such as bungs
for vials or in similar applications such as gaskets in aerosol cans.
Categories of Rubbers:
Natural rubbers: Suitable for multiple use closures for injectable
products as rubber reseals after multiple insertion of needle.
Synthetic rubber: Have fewer additives and thus fewer
extractable and tends to experience less sorption of product
ingredients.
Some other types of rubber used includes: Butyl rubber;
Nitrile rubber; Chloroprene rubbers; Silicon rubbers etc.
Symbols Used On Packages and Labels
Many types of symbols for package labeling are nationally and internationally standardized. For product
certifications, trademarks, proof of purchase, etc. identification code.
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Unit Dose packaging
Blister Packing: In blister packing the unit dosage forms are enclosed in between transparent blisters
and suitable backing material usually aluminum foil.
Strip Packing: In strip packing the unit dosage of drugs are hermitically sealed in between strips of
aluminum foil and/or plastic film.
Advantages of Blister Package:
1. Prevention of broken glass bottles
2. Reduced costs and higher packaging speeds relative to other packaging materials.
3. Blister packaging helps retain product integrity because drugs that are prepackaged in blisters are
shielded from adverse conditions.
4. Furthermore, opportunities for product contamination are minimal.
5. Each dose is identified by product name, lot number, and expiration date.
6. Blister packaging protects pharmaceuticals in the home better than bottles do.
7. Tamper evidence is another strength of blister packaging. The dosage units are individually
sealed in constructions of plastic, foil, and/or paper. With blister packaging, however, each tablet
or capsule is individually protected from tampering until use, so any form of tampering with a
blister package is immediately visible.
Two basic types of pharmaceutical blister packages exist
1. In one variety the cavity is constructed of clear, thermoformed plastic, and the lid is formed of
clear plastic or a combination of plastic, paper, and/or foil.
2. The other type of package contains foil as an essential component of both webs, and its cavity is
created by cold stretching.
Cold Forming Blistering machine:
In the case of cold forming, an aluminum-based laminate film is simply pressed into a mold by means of
a stamp. The aluminum will be elongated and maintain the formed shape.
Advantage of cold form foil blisters is that the use of aluminum is offering a near complete barrier for
water and oxygen, allowing an extended product expiry date.
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The disadvantages of cold form foil blisters are the slower speed of production compared to
thermoforming and the lack of transparency of the package and the larger size of the blister card
Example: ALU-ALU Machine
Operation:
The sequence involves;
1. Installing the Aluminium Foil,
2. Cold forming it into blister cavities via punch pins,
3. Loading the blister with the product,
4. Placing lidding material over the blister,
5. And heat-sealing the package.
6. Cutting into individual blisters
Thermo-cold forming blistering machine:
In the case of thermoforming, a plastic film or sheet is unwound from the reel and guided though a pre-
heating station on the blister line. The temperature of the pre-heating plates (upper and lower plates) is
such that the plastic will soften and become moldable.
Example: ALU-Tropical Machine
Operation:
The sequence involves;
1. Heating the plastic,
2. Thermoforming it into blister cavities,
1. Bottom foil uncoiler 6. Cover foil uncoiler 11. Discharge conveyor
2. Cold forming station 7. Cooling & slitting
3. Feeding device 8. Draw Off
4. Empty checker 9. Punching
5. Sealing & Embossing 10. Waste foil coiler
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3. Loading the blister with the product,
4. Placing lidding material over the blister,
5. And heat-sealing the package.
6. Installing the aluminium foil
7. Cold forming it into blister Pouch & seal it on thermoformed blister to give extra protection,
8. Cutting into individual blisters
STRIP PACKAGE
 It is commonly used for the packaging of tablets and capsules.
A strip package is formed by feeding two webs of a heat
sealable flexible film through a heated crimping roller.
 The product is dropped into the pocket formed before forming
the final set of seals. A continuous strip of packets is formed
which is cut to the desired number of packets in length.
 The materials used for strip package are cellophane, polyester,
polyethylene, polypropylene, polyvinylchloride.
Fig: Strip Packaging Machine
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Basic principles of compounding and dispensing: Prescription and Labeling
Prepared By: Md. Imran Nur Manik; M.Pharm. (R.U.)
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PRESCRIPTION
Definition
A prescription is an order form a registered practitioner o0r other properly licensed practitioner such as
physician, dentist, veterinarian or dermatologists etc to a pharmacist to compound and dispense a
specific medicine for the patient.
Parts of Prescription
1. Date
2. Name, age, sex and address of the patient.
3. Superscription (Rx)
4. Inscription
5. Subscription
6. Signatura
7. Renewal instructions
8. Name, signature, address & registration no. of registered physician
Date
It helps the pharmacist to find out the date of prescribing and the date of prescription for filling. It also
helps
-to know when the medicines were last dispensed,
-to prevent the misuse of the drug by the patients.
The prescription which prescribes narcotic or other habit forming drugs must bear the date so as to
avoid the misuse of the prescription.
Name, age, sex and address of the patient
Name, age, sex and address of the patient must be written in the prescription because it serves to
identify the prescription. Age and sex of the patient especially the children, help the pharmacist to check
the prescribed dose of the medicine.
Superscription (
It is represented by the symbol Rx, which is written before writing the prescription. Rx is an abbreviation
of the Latin imperative verb, “recipe = take” meaning “to take” (Take though).
Inscription (
This is the main part of the prescription, contains the names and quantities of the prescribed ingredients
The names of the ingredients are generally written in English but common abbreviation used can be
written both in English and Latin language. Extreme care should be taken by the pharmacist during
interpreting the abbreviations otherwise can lead to serious errors.
Inscription is divided into following parts
I. Base: The active ingredients which are intended produce the therapeutic effect.
II. Adjuvant: It is included either to enhance the action of the medicament or to improve the
palatability of the preparation.
III. Correction: It is included to prevent or lessen any undesirable effect.
IV. Vehicle: It is included in the prescription either to dissolve the solid ingredients or to
increase the volume of the prescription.
Subscription
Subscription provides the direction to the pharmacist for the preparation of the prescription
information and the quantity and dosage form of the drug to be dispensed.
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Signatura
This consists of the direction to be given to the patient regarding the administration of the drugs. The
instruction may include
a. The quantity to be taken or the amount to be used.
b. The frequency and timing of drug administration
c. The route of drug administration
d. The special instruction such as dilution direction.
Renewal instruction
The prescriber indicates on every prescription, whether it may be renewed and if so how many times. It
is particularly important for the prescriptions containing the narcotic and other habit forming drugs to
prevent its misuse.
Name, signature, address & registration no. of the prescriber
The prescription must bear the signature of the prescriber along with the registration number and
address.
PRIME NURSING HOME
Banani, Dhaka-1213
Phone:+8802453765
Name : Mr. Shajib Khan Age: 25 yrs Sex: Male Date:30.08.2016
Address:222/2 Middle Auch para, Tongi ,Gazipur-1711
Sodium bicarbonate----3 gm
Compound tincture of cardamom---2 gm
Inscription Simple syrup-----------6 ml
Water q.s.
Make a solution (Subscription)
Take with water(Signatura)
Refil:- Sd
Dr. Tarique Nasim
M.B.B.S., MD
Reg.No.- 1234
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Types of prescription
Prescriptions may be of the following types
1. National Health Service Prescriptions.
2. Private prescriptions from doctors, dentists or veterinary practitioner.
3. Prescription for hospital in patients
4. Prescription for medicine to be taken at home by the patient, discharged from the hospital ward.
5. Hospital outpatient prescription.
Labeling of Dispensed Medications
The label for a dispensed product should provide the patient with all the information required for its
proper use. The information include
1. Accurate: The label should be checked immediately after writing and again before fixing to the
container.
2. Legible: It should be easily readable, it should be either type written or printed.
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3. Intelligible: The information given on the label should be completely unambiguous ( ) and
arranged to avoid any confusion.
4. Adequate and relevant: The information provided should be adequate and relevant in order to
avoid confusion and anxiety.
Information on the label
The followings are the important things which should be included in the label
1. Indicate clearly the patient, for whom it has been prescribed.
The patient’s title, forename (নামের প্রথে অংশ), initial name or surname (পদবি) should appear on the label of
each medicine dispensed.
2. Indicate the name and address of the supplier and the date of supply.
The name and address of the pharmacy may be printed on the dispensing labels.
3. In most of the cases give precise details as to the contents of the container when dispensed.
This includes
a. The quantity in the container: The total quantity of the product dispensed in the container
should be indicated on the label.
b. The name of the product /medicine: In the community pharmacy the name written by the
prescriber should appear on the label. In the hospital pharmacy only non-proprietary name is
used.
c. The strength of the medicine: It is essential for preparations that are essential in different
strengths of medicine. e.g. amount in each tablet/capsule.
d. Units: Wherever possible quantities should be expressed as whole numbers of unit. e.g. 100 mg
rather than 1gm.
e. Batch identification: The batch reference should be included in the labeling (UK).
f. Diluted products: Particular care should be taken when labeling medicines prepared by the
dilution of more concentrated products.
4. State the storage condition and shelf life of the medicine.
This includes
a. Temperature: A large number of products need to be stored in a cool place. e.g. suppositories.
b. Humidity: Solid unit dosage forms should be protected from moisture. (Air +moisture proof
container)
c. Light: The light sensitive products should be stored in the amber colored containers.
d. Sources of ignition: Products containing a large proportion of flammable ingredients should be
labeled “flammable” and keep away from naked flames.
e. Shelf life: The period during which the quality of a medicine is expected to remain within the
acceptable limits.
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5. Give clear and complete instruction to the patient on how and when to take or use the
preparation.
This Includes
a. Directions: Includes quantity to be taken or amount to be used, frequency and timing of
application, route of administration etc.
b. Shake the bottle: Emulsion, suspension etc.
c. Take with water: Mixtures that can cause gastric irritation. E.g. Disprin (Aspirin)
Cautionary and Advisory Label
In general the patient requires adequate information, so that the medicine can be taken safely and
effectively. Guidelines for the pharmacist on the Cautionary and Advisory Label to be applied to the
dispensed medicine are provided by the Royal pharmaceutical society of Great Britain.
The guidelines are as follows
1. For external use only
This label must be applied to the liquid preparations or gels for external application. The label is also
applied to all semisolid or solid medicinal products for external use. e.g. Ointments, Creams, Dusting
powders etc.
2. Not to be taken
This label may be used on preparations that’s are neither administered by mouth nor used on the skin.
This label may be confused with the words “For external use”. Therefore “For nasal use only”
“For rectal use only” “For vaginal use only” label may be preferred.
“Not to be swallowed in a large amount” is a better label for the mouth washes and gargles where
swallowing of a small amount is ineffective but swallowing in a large quantity is undesirable.
3. Hexachlorophane warning
Products containing Hexachlorophane should not be used indiscriminately in every young child or in
certain animals because of the possibility of the serious toxicity. A warning to this effect should be
included on the labels of the products containing the substances.
[A topical antibacterial formerly widely used in wound care and as a surgical scrub. Application to mucousmemb
ranes, denuded or burned surfaces, and intact skin in newborns has resulted in fatal CNS lesions. Use iscurrentl
y restricted to disinfection of intact adult skin. Products containing more than 0.1% hexachlorophene areavailable
only by prescription.]
4. Keep out of reach of children
All medicine should be stored in the place inaccessible to the children and must be so labeled.
5. For animal use/treatment only
A clear distinction must be made between the medicine intended for human use and those for veterinary
use.
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6. Drowsiness warning
Patients should be warned if their medicines are likely to cause drowsiness, dizziness (োথা ঘ ারা) blurred
vision( .
7. Potential interactions with food and drinks
a. Drugs for which absorption is improved if taken before food.(meal)
b. Drugs for which GI irritation occurs if taken before food.(empty stomach)
8. Potential inter actions with other medicines
a. Drugs which chelates with calcium, magnesium and iron and are not well absorbed in the
presence of irons.
b. Drugs whose activity is reduced by aspirin
9. Special methods of administration
a. For chewable formulations
b. For sublingual formulations
10. Caution in use
a. Preparations which may produce unusual effect.
b. Preparations containing high proportion of flammable solvent.
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Basic principles of compounding and dispensing MANIK

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