Basic principles of compounding and dispensing:prescription, labeling of dispensed medications

Md. Imran Nur Manik

Lecturer

Department of Pharmacy

Primeasia University

Md. Imran Nur Manik

Md. Imran Nur 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

[email protected]; 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.

Md. Imran Nur Manik

Md. Imran Nur Manik




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.

Md. Imran Nur Manik

Md. Imran Nur Manik




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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Md. Imran Nur Manik




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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Md. Imran Nur Manik




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 vapour 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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Md. Imran Nur Manik




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.

Md. Imran Nur Manik

Md. Imran Nur Manik




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.

Md. Imran Nur Manik Lecturer

Department of Pharmacy Primeasia University

Md. Imran Nur Manik

Md. Imran Nur Manik

Basic principles of compounding and dispensing: Prescription and Labeling



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 ( ঘ মন র শ ম ি ি মর শ ি (ঘ েন র মের উপর ন ); উপ রম ।) 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 (অ ন) 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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Md. Imran Nur Manik




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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Md. Imran Nur Manik




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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Md. Imran Nur Manik




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 (ন মের রথে অংশ), initial name or surname (পদ ি) 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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Md. Imran Nur Manik




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 iscurrently 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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Md. Imran Nur Manik




6. Drowsiness warning Patients should be warned if their medicines are likely to cause drowsiness, dizziness (ে থ ঘ র ) blurred vision( প ).

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.

Basic principles of compounding and dispensing:prescription, labeling of dispensed medications

Health & Medicine

Transcript of Basic principles of compounding and dispensing:prescription, labeling of dispensed medications