labelling of pharmaceuticals

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deals with the types of labelling for pharmaceuticals

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By: gkpendem (129 month(s) ago)

one of good ppt i hav seen

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LABELLING OF PACKAGING MATERIALS:

LABELLING OF PACKAGING MATERIALS Presented by: SHILPA RAO M.Pharm 1 st yr Pharmaceutics Mallareddy college of pharmacy Hyderabad

INTRODUCTION:

INTRODUCTION The term labelling designates all labels and other written, printed or graphic matter up on or in any package or wrapper in which it is enclosed The label states the name of the preparation, percentage content of drug of a liquid preparation, the amount of active ingredient of a dry preparation, the volume of liquid to be added to prepare an injection or suspension from a dry preparation, the route of administration, a statement of storage condition and expiry date. Also label must indicate the name of manufacturer or distributors and carry an identifying lot number.

Types Of Labels :

Types Of Labels Various materials are used for labelling such as paper, foil and fabric. it is also possible to print directly on a bottle or other containers by means of silk screen, offset or hot transfer process. 1.PAPER LABELS: Most labels are printed on paper, since this is the most economical method, whether the quantities are large or small. They can be produced by any of the graphic processes, such as letter press, offset, gravure or hexography . There is no limit to the colours and techniques that can be used in case of paper label. Paper labels can be die-cut or guillotine cut.

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a) Die-Cut It provides accurate dimensions and freedom of design, such as rounded corners and it is higher in cost. b) Guilotine Cut Labels Majority of the labels are guillotine cut, some variations in size will occur with guillotine cutting, depending up on the skill of the operator. The designs of the label are limited to straight parallel edges with this method and the corners are always square and sharp . 2.FOIL LABELS: It is nearly always necessary to laminate foil with paper so that the label will work properly in the labelling machines. The foil and paper together should measure 0.0025 to 0.003inch for best results. Adhesives that contain solvents cannot dry as quickly through the foil as through a paper label and so heat sensitive coatings are often used for this reason. The appearance of a well-printed foil label is superb and the bright reflective surface adds glamour to almost any package. Special inks are required for printing on foil and it may be necessary to use a primer as well as good adhesion

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. 3] Transfer Labels There are several processes for transferring heat sensitive inks from a pre-printed strip to the container that is to be decorated. These are known by the trade names of · Therimage · Di – Ni – Cal(diamond national corp.) · Howmet · Tronsdec Electoral · Electoral* 4) Sleeve Labels There are the two types of sleeve labels- § Stretch band and § Shrink tubing Two-mil low-density polyethylene film is used for stretch type labels. Heat shrinkable labels are made of 3-mil polyvinyl chloride film. They can be applied by hand or with automatic equipment .

PRINTING PROCESS:

1.Letterpress: Most widely used method of printing labels It permits good colour control with clear, sharp details. A variation of this, in which the printing is not direct from plate to paper but is transferred from the plate to a rubber roller and then to a paper. is called letterset. PRINTING PROCESS 2.Flexographic method : printing : Fastest growing technique . Quality of this type of printing is not best but it requires the least expensive equipment. For this reason it is popular in the smaller shops and is used for printing pressure sensitive labels. 3.Gravure process : : For long runs the gravure process is the most dependable. Colour log down is excellent and particularly with fluorescent inks it gives better coverage than any other process.

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4.screen printing : For limited use, screen printing is applicable to very short runs. A very heavy lay down of colour is possible. Computers are being used to print labels where a great variety of labels in small quantities are needed. An intelligent dot matrix printer is connected to central processing units with a cathode ray tube, screen and a keyboard. There are usually two disk drives that bring the information out of memory. Disk 1 : C ontains the data for the label format is the size of type, borders, bar codes and general arrangement. Disk 2 : W ill have the standard information for each product. If variable information, such as lot number or expiration has been verified on the screen, the command is given on the keyboard to print the required number of labels. The printer produces the labels at 600 lines per minute on fan folded paper that is perforated between labels.

ADHESIVES:

ADHESIVES 1.COLD GLUE: Starch or dextrin types: The lowest cost glue , They are fairly fast drying but they are not waterproof or ice proof when immersed. Jelly gums : Ideally used in the pharmaceutical industry, and they work well under adverse conditions of hot, oily or wet containers. They have limited water resistance when immersed, but satisfactory for high humidity conditions. Animal glues : are used to some extent for beverage bottles because they have good resistance immersion in ice water 2.PRESSURE SENSITIVE For a clean operation with quick change over, easy in printing and low cost equipment, many companies are switching to pressure sensitive labels. Although the cost of the labels are higher than for other types, the machines for applying them are only about half the cost or cold glue and heat seal labels. Disadvantages · Slow speed. · Frequent roll changing. · Labels cannot be soaked off easily. · High label cost. · Inaccurate placement of labels. · Poor resistance to oils and solvents.

Heat Seal Coatings: :

Heat Seal Coatings: There are two types of heat activated coatings that are used on labels. Sealing directly to the object with heat and pressure. As soon as adhesive cools, it becomes hard. Which is more often used for bottle labels, is softened by heat and remains soft for a considerable period of time. The cost is about halfway between that of plain paper labels and pressure sensitive labels.

Method Of Applying A Label: :

Method Of Applying A Label : 1.Hot Melts A simple method of applying a label to a package is with a pasting out board. Glue is put on the board with a brush and the labels are laid face up on the glue. They are manually removed and placed on the containers. 2. Semi Automatic Labelling With this method the operator places the container in position and the machine applies the label. The speed of the operation is usually dependent upon how fast the operator can remove the container and put a new one in its place. About 3600 per hour is the maximum ideal condition. 3. Fully Automatic Labelling Glue is applied to the label by a rubber pad, often which the label magazine moves forward to the bottle and back again leaving a label adhering to the bottle, pressure station complete the operation.

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Code Marking : For required by the government or simply for the convenience of the company. Code marking is practiced by many different industries. Bar Codes : Basically a bar code is a series thick and thin machine readable lines containing information necessary for a particular operation. It can be used for verification, tracking, sorting or taking inventory. There are many different systems, Costs : The cost of plain paper labels compared with those for heat seal and pressure sensitive labels are in a ratio of about 1:3:6. The market segment for labels in India is estimated at 30%. for processed food, 11% for pharmaceuticals, 10% liquor and brewery, 6% personal care product, 5% hydrogenated and non hydrogenated oils.

Labelling For Different Dosage Form :

Labelling For Different Dosage Form A. Labelling Of Dispensed Medicines: The label on dispensed medicines has two main functions, one is to uniquely identify the contents of the container, and other is to ensure that patients have clear and concise information .

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Standard Requirement For Labelling Dispensed Medicines: All labels must be type written or computer generated. The details, which must appear on the label of a dispensed medicine are- · The name of the preparation. · The quantity. · Instructions for the patient. · The patient name. · The date of dispensing. · The name and address of the pharmacy. · Keep out of reach of children.

Additional Labelling Requirement for dispensed medicines::

Additional Labelling Requirement for dispensed medicines : Storage: The pharmacists while stating the storage conditions on the label may follow the following guidelines. i . Temperature: A large number of products need to be stored in a cool place preferably below 15c. Immunological products and insulin injections are usually required to be stored between 2 to 8c. Formaldehyde should be stored in moderately warm place. ii. Humidity: Solid unit dosage form should be protected from moisture. Such products should be supplied in air and moisture proof container and patient should be guided to replace the cap after use. iii Light: The light sensitive product should be stored in amber colour containers. A few substances such as paraldehyde must be stored in complete darkness.

Instruction To The Patient:

Instruction To The Patient There should be clear and complete instructions to the patient on how to take or use the preparation . Direction- The phrases such as ` to be taken ` ` to be given ` or ` to be used ` are preferred to `take` `give` `use`. b) Shake the bottle before the use- c) Take with water- Mixture, which can cause gastro intestinal irritation, or mixtures for adult patients having a dose 10 ml or more should be diluted with water before taking it .

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Batch Number: When a product has been prepared it is good practice to award it a batch number and incorporate this into the label. Expiry Date: There are however specific occasions when an expiry date must be added to the label. An expiry date should always be put on to any extemporaneously prepared items. An expiry date should always be used when a product has been diluted, thereby affecting the stability and shelf life. An expiry date should always be indicated when the preparation is sterile, e.g. eye drops. Do not use after (date) are preferred methods of expressing expiry dates or “EXP 6/09”, “EXP June 89”, “Expires 6/9”.

B.Labelling of Veterinary Dispensed Products:

B.Labelling of Veterinary Dispensed Products The word ‘For animal use only’ or similar must always be added to the label of a dispensed veterinary product. Instead of the patient name the name of the animal’s owner should appear along with the owners address or the address where the animal lives.

C. Drug Needing Cautionary Labelling::

C. Drug Needing Cautionary Labelling: s.no DRUG PARTICULARS 1. Schedule G drugs “Caution: It is dangerous to take this preparation except under medical supervision” 2. Schedule H drugs I. “Schedule H drugs Warning: To be sold on the prescription of a Register Medical Practitioner” II. Symbol R x prominently on left hand top corner of the label. III. Symbol N R x prominently on the left hand top corner if drug is covered under Narcotic Drugs and Psychotropic substance Act. 3. Schedule X drugs I. Schedule X drugs Warning: To be sold on the prescription of RMPs only. II. Symbol X R x in red on left hand top corner. 4. Schedule C drugs I. When the test for maximum toxicity is prescribed a statement that it has passed that test. II. Nature & percentage of antiseptic, if any. 5. Veterinary drugs I. Not for human use. For animal treatment only. II.Head of any domestic animal. 6. Ophthalmic solutions/ suspensions/ ointments I.Use with in one month of opening. Not for injection. II. Name and concentration of preservative. III. Do not touch the dropper tip/ other dispensing tip to any surface since this may contaminate.

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Drowsiness warning: Patients should be warned if their medicine is likely to cause drowsiness, dizziness, and blurred vision. The following wording may be written on the label Warning: May cause drowsiness, if affected do not or operate machinery, avoid alcoholic drink. Potential interaction with food or drink: The following type of wording may be written on the label under different conditions: Drug in which absorption is improved if taken before meal Warning: To be taken an hour before taking food. Drug which causes G.I irritation or are better absorbed with food Warning: To be taken with or after food Alcohol may provoke a reaction such as flushing when taken in combination with drugs such as metronidazole . Warning: Avoid alcoholic drink.

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Special method of administration: T he following wording may be written on the label if there is some special method of administration. The drug formulation which is required to be dissolved in the mouth To be sucked or chewed. The drugs which are to absorbed through sublingual mucosa To be dissolved under toung . The drugs which are soluble in water or for powders or granules to be dispensed in water before takin . Dissolve or mix with water before taking. The drugs which are likely to cause G.I irritation unless it is well diluted To be taken with plenty of water. The drugs which are to be used for enteric coated, sustain release or having unpleasant taste To be swallowed whole, not to be chewed.

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Cautions in use: The following wording may be written on the label in order to caution a patient about certain unusual happenings after taking the medicine. 1. The preparation, which may induce photosensitization. 2. Avoid exposure of skin to direct sunlight. 3. The preparation, which may produce unusual effect. 4. The preparation may colour the urine or stool. 5. The preparation, which contain high proportion of flammable solvent. 6. Keep away from naked flame .

Special Labelling Instructions for particular type of dispensed dosage form::

Special Labelling Instructions for particular type of dispensed dosage form: Sr. No. Name of Preparation Labelling Instructions 1 Aerosol and inhalations Pressurized containers keep away from heat source. Shake before use. Do not exceed the prescribed dose follow the instructions. 2 Applications For external use only. 3 Capsules Swallow with a draught of water. 4 Creams For external use only. Store in a cool place. 5 Dusting powders For external use only. Not to be applied on open wound or to raw or weeping surface. 6 Ear drops For external use only.

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7 Emulsions Shake the bottle before use. 8 Enmos For rectal use only. Shake well before use. Warm to body temperature before use. 9 Eye Drops To be used in 30 days after first opening 10 Eye lotions To be used with 24 hrs after first opening. 11 Gargles and mouth washes Not to be swallowed in large amounts. 12 Granules To be dissolved or dispersed in water before taking. 13 Inhalations Not to be taken. Shake the bottle before use. 14 Insufflations Not to be swallowed. 15 Linctuses To be slipped and swallowed slowly without the addition of water. 16 Liniments and Lotions For external use only. Shake the bottle before use. Do not apply on broken skin. 17 Mixtures Shake the bottle before use. To be taken only after diluting with water.

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18 Nasal drops For nasal use only. 19 Ointments For external use only. Sterile not to be used be used for injection. 20 Paints For external use only. 21 Passaries For vaginal use only. Store in cool place. For external use only. 22 Pastes For external use only. 23 Solutions For external use only. Sterile not to be used be used for injection. For rectal use only. 24 Suppositories For rectal use only. Store in a cool place. 25 Tablets 1. For soluble or dispersible tablets 2. For chewable tablets 3. For sustain release, enteric coated or unpleasant tasting tablets. Dissolve or dispensed in water before taking. Chew before swallowing. Do not crush or chew.

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Abbreviated Titles Used In Label: To discourage prescribes, frusted by the long names of many immnological preparations such as Diphtheria, Tetanus, Pertussis , and Pliomyelitis vaccine. From using confusing abbreviations the pharmacopoeia gives official abbreviated titles that must also used on the labels of the containers and package or the product. The first part is usually a shortened version of the name of the disease or casual organism. Where only one disease or organism if relevant, three Ex: Dip for Diphtheria But Flu for influenza and Typhus is unabbreviated Where more than one disease or organism is relevant a single letter designs each if the meaning cannot be in doubt. When this is not possible the first three letters of the name are used Ex: TAB for typhoid, paratyphoid A, paratyphoid B TABCho for typhoid, paratyphoid A, paratyphoid B and cholera

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The second part separated from the first by a diagonal line is a three-letter abbreviation indicating the type of product Ex: For vaccines- Vac For antisera - Ser But for Staphalococcus toxide - Sta / Tox Another example: Tet / Ser – Tetanus antitoxin Plague/ Vac – Smallpox vaccine Var / Vac – Dipthria , tetanus, pertusis , poliomyelitis vaccine Tub/ Vac / BCG ( perc ) – Percutaneous Bacillus Calmette Guerin vaccine.

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Labeling Of Parenterals : Parentral containers vary greatly in size from 1ml ampoules to 3 liter bags. It is difficult to put much information on a label intended for a 1ml ampoule and it is not important not to completely obligate the product from view. The USP states that the label must leave a sufficient area of the container uncovered for its full length of circumference to permit inspection of content. The BP requires that where appropriate the label must state the strength of the preparation in terms of amount of active ingredient in a suitable dose of volume. The label must also state the name of any added substance, the expiry date and storage conditions.

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Statement of storage condition is becoming increasingly important based on the temperature at which long term stability data have been generated. European regulating authority requires stability data generated at 25 o C and 60% relative humidity. The FDA currently requires data at 30 o C and 60% relative humidity. The requirements vary for different market depending upon the climatic condition. USP requires more information regarding added substances. It requires the percentage content of each ingredient or the amount of each ingredient in a specified volume. The USP requires the route of administration to be stated. The BP also has specific requirement for concentrated solution of injection. In this instance the label must state the name of the concentrated solution that the solution must be diluted and the direction for preparation of the injection or infusion.

Labeling of Ointment Tubes:

Labeling of Ointment Tubes Attaching labels to ointment tubes is a minor difficulty compounded by the increasing unsightliness characteristic of many ointment tubes during use. On a manufacturing scale tubes are labeled in a variety of ways. Paper labels may be used, labeling may be silk screened onto plastic surface. Expiration data and code lot number may be stamped on as a part of the tube crimping procedure.

Labelling Of Ophthalmic Preparation:

Labelling Of Ophthalmic Preparation The European pharmacopoeia and BP specify the following requirement for labeling of ophthalmic preparation- 1) Eye Drops: The label should state the name and concentration of any antimicrobial preservative or other substance added to the preparation. For multidose containers the label should state the period after opening the containers after which the contents should not be used. 2) Eye Ointments: The label should state the name and concentration of any antimicrobial preservative or other auxiliary substance added to the preparation. 3) Eye Lotions: The label should state the name and concentration of any antimicrobial preservative added to the preparation for single use container the label should state that the period after opening the container after which the content should not be used.

Codes For Eye Drops In Single Dose Containers::

Codes For Eye Drops In Single Dose Containers : Sr. No. Eye Drops Code 1 Adrenaline, neutral ADN 2 Amethocaine AME 3 Atropine sulphate ATR 4 Benozinate BNX 5 Betamethasone BET 6 Carbachol CAR 7 Castor oil CASOIL 8 Chloramphenicol CPL 9 Cocaine CCN 10 Cyclopentolate CYC

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11 Fluorescein FLN 12 Gentamicin GNT 13 Homatropine HOM 14 Hydrocortisone HCOR 15 Hyoscine HYO 16 Hypromellose HPRM 17 Lachesine LAC 18 Lignocaine & Fluorescein LIGFLN 19 Metipranolol MPR 20 Neomycin NEO 21 Phenylephrine PHNL 22 Phenylephrine & Cyclopentolate PHNCYC 23 Physostigmine ESR 24 Pilocarpine PIL

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25 Prednisolone PRED 26 Proxymetacaine PROX 27 Rose Bengal ROS 28 Sulphacetamide SULF 29 Thymoxamine THY 30 Tropicamide TRO 31 Zinc Sulphate ZSO

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Labeling Of Alcohol: The content of alcohol in a liquid preparation shall be stated on the label or a percentage (v/v) of C 2 H 5 OH. Labeling Of Vitamin Containing Products: The vitamin of pharmacopoeial preparation shall be stated on the label in metric units per dose unit. The amount of vitamin A, D and E may be stated in USP units. The label of nutritional supplement shall bear on identifying lot number, control number or batch number.

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Labeling Of Electrolytes: The concentration dosage of electrolytes for replacement therapy (ex: Sodium chloride or potassium chloride) shall be stated in the label in milliequivalents ( mEq ). The label of the product shall indicate also the quantity of ingredients in terms of weight or percentage concentration. Labeling Of Internal Powders: Powders are usually mixed with water or other suitable liquid. Powder for babies or young children can be placed directly in mouth on the back of toung , followed by a drink to wash out the powder. Bulk powder should be shaken and measured carefully before dissolving or dispersing in a little water and taking.

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Labeling Of Powders For External Use : ‘For external use only’ and ‘Store in cool and dry place’ Example for official powder for external use include zinc oxide dusting powder compound BPC chlorhexidine dusting powder BP and talc dusting powder BP.

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Special labels and advice on tablets :: Most tablets should be swallowed in a glass or draught of water. A draught of water refers to a volume of water of about 50ml. This prevents the dosage from becoming lodged in the esophagus. Coated tablets: Eg : 1. Enteric coated requires special advice on avoiding indigestion remedies at the same time of day. 2. Buccal and Sublingual tablet: are not swallowed whole and it is important that patients know how to use them. If these formulations are swallowed then they will not have their intended therapeutic effect.

Labeling Requirements For Eye Drop And Eye Ointment Container At The Time Of Dispensing::

Labeling Requirements For Eye Drop And Eye Ointment Container At The Time Of Dispensing: Sr.No Requirement Include on label 1 State route of administration For external use only 2 Fully identify the product The name and concentration of active ingredient(s) 3 Statement on preservation Confirm presence or absence of preservative 4 Direction for use Ex: Add one drop to each eye morning and evening. 5 Statement on in use expiry date Day, month, year 6 Storage requirements ‘Store in cool place’ or ‘Protect from light’ 7 Identify patient Patient’s name 8 Date of dispensing Day, month, year

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Labeling Of Poisons: The basic labeling requirements are- The name of the substance. The name, address and telephone number of the supplier. An indication of general nature of the risk ex: toxic, corrosive, teratogenic . The symbols specified for the above risk ex: skull and cross bones. Risk phrases these are the general statements of properties of the substance ex: ‘cause severe burns’. Safety phrases these contain advice on what to do to avoid problems ex: ‘wear suitable protective clothing’, ‘Do not breathe vapor’.

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Symbols used on labels

CONCLUSION:

CONCLUSION Labels gives cute and mute to a large resource of the story of a product and market, affixed to almost any surface to depicting contents, nature, ownership and destination. The term labelling designates all labels and other written, printed or graphic matter up on or in any package or wrapper in which it is enclosed. The label states the name of the preparation, percentage content of drug of a liquid preparation, the amount of active ingredient of a dry preparation, the volume of liquid to be added to prepare an injection or suspension from a dry preparation, the route of administration, a statement of storage condition and expiry date. Also label must indicate the name of manufacturer or distributors and carry an identifying lot number.

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http://www.pharmainfo.net/reviews/pharmaceutical-labeling-review http://en.wikipedia.org/wiki/Packaging_and_labeling#Packaging_machines REFERENCES

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http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=423551&sk=&date=&pageID=7