Compounding and Dispensing 519 Lab Manual Final
Compounding and Dispensing 519 Lab Manual Final
PD-519
LAB MANUAL
PHARM. D, 3rd YEAR, SEMESTER-V
NAME:____________________________
ROLLNO._______________________
THEORY
EMULSION:
An emulsion consists of two immiscible liquids one of which is uniformly dispersed through the
other as droplets of diameter greater than 0.1 m.
The system is stabilized by the presence of emulsifying agent. The particle diameter of the disperse
phase extends from 0.1 to 100 m.
Pharmaceutical application of emulsions:
Oral products
The use of sterile stable IV emulsion containing fats, carbohydrates and vitamins as a
potential nutrition
Topical use:
Washable
Acceptable viscosity
Less greasy
TYPES OF EMULSION:
Oil-in-water (O/W)
Water-in-oil (W/O)
Multiple emulsions
Oil-in-water-in-oil (O/W/O)
Water-in-oil-in-water (W/O/W)
Micro emulsions
Conductivity measurement
Fluorescence test
PREPARATION OF EMULSIONS
A- Trituration Method
This method consists of dry gum method and wet gum method.
1- Dry Gum Method
In this method the oil is first triturated with gum with a little amount of water to form the primary
emulsion. The trituration is continued till a characteristic clicking sound is heard and a thick white
cream is formed. Once the primary emulsion is formed, the remaining quantity of water is slowly
added to form the final emulsion.
2- Wet Gum Method
As the name implies, in this method first gum and water are triturated together to form a mucilage.
The required quantity of oil is then added gradually in small proportions with thorough trituration to
form the primary emulsion. Once the primary emulsion has been formed remaining quantity of
water is added to make the final emulsion.
B- Bottle Method
This method is employed for preparing emulsions containing volatile and other non-viscous oils.
Both dry gum and wet gum methods can be employed for the preparation.
As volatile oils have a low viscosity as compared to fixed oils, they require comparatively large
quantity of gum for emulsification. In this method, oil or water is first shaken thoroughly and
vigorously with the calculated amount of gum. Once this has emulsified completely, the second
liquid (either oil or water) is then added all at once and the bottle is again shaken vigorously to form
the primary emulsion.More of water is added in small portions with constant agitation after each
addition to produce the final volume.
Auxiliary method:
An emulsion prepared by other methods can also be improved by passing it through a hand
homogenizer, which forces the emulsion through a very small orifice, reducing the dispersed droplet
size to about 5 microns or less.
In situ soap method
Calcium Soaps:
W/O emulsions contain oils such as oleic acid , in combination with lime water ( calcium hydroxide
solution, USP).
Are the substances added to an emulsion to prevent the coalescence of the globules of the
dispersed phase.
They act by reducing the interfacial tension between the two phases and forming a stable
interfacial film.
The choice of selection of emulsifying agent plays a very important role in the formulation of a
stable emulsion.
No single emulsifying agent possesses all the properties required for the formulation of a stable
emulsion therefore sometimes blends of emulsifying agents have to be taken.
Depending on the use, emulsions should be packed in suitable containers. Emulsions meant
for oral use are usually packed in well filled bottles having an air tight closure.
For viscous emulsions, wide mouth bottles should be used. The label on the emulsion should
mention that these products have to be shaken thoroughly before use.
External use products should clearly mention on their label that they are meant for external
use only.
Emulsions should be stored in a cool place but refrigeration should be avoided as this low
temperature can adversely effect the stability of preparation.
REFERENCES:
Ansels pharmaceutical dosage form and drug delivery systems
Eighth edition
Pg:404-415
Date:
EXPERIMENT#
OBJECT:
To prepare and dispense 25 ml of Liquid Paraffin emulsion
FORMULA:
Liquid paraffin
50.0 ml
Gum powder
12.5 g
Tragacanth powder 0.
Sodium benzoate
0.5 g
Vanillin
0.05 g
Glycerin
12,5 ml
Chloroform
0.25 ml
Purified water, sufficient to produce 100 ml
PROCEDURE:
1. Triturate the weighed quantity of liquid paraffin and chloroform with the gums, add tragacanth and
vanillin in mortar and pestle.
2. Add 25.0 ml of purified water and triturate until a creamy emulsion is formed.
3. Dissolve sodium benzoate in small quantity of purified water.
4. Add glycerin and solution of sodium benzoate with continuous triturate.
LAB MANUAL;COMPOUNDING AND DISPENSING
PD-519
5. Add sufficient purified water to produce 100 ml of emulsion and mix properly.
STORAGE:
Emulsion should be kept at temperature not exceeding 20C. It should not be allowed to freeze.
USES:
Laxative
Date:
EXPERIMENT#
LAB MANUAL;COMPOUNDING AND DISPENSING
PD-519
OBJECT:
To prepare and dispense 25 ml of Liquid paraffin and Magnesium hydroxide emulsion
FORMULA
Liquid paraffin
25 ml
Chloroform spirit
1.5 ml
100 ml
4.75 g
Sodium hydroxide
1.5 g
5.25 g
Chloroform
0.25 ml
THEORY
PASTE:
DEFINITION:
Semisolid preparations intended for application to skin
CHARACTERISTICS FEATURES:
Stiffer than ointment because Contain larger proportion of solids material (25%).
Semisolid form contain one or more drug substance intended for topical application
Poorly occlusive
BY MIXING or BYUSE OF HEAT to soften the base before incorporating the solids.
Cool place
2 weeks expiry
CONTAINER:
10
DATE:
EXPERIMENT#
OBJECT:
Prepare 25 g Zinc Gelatin BP 1968 (Unna's paste)
FORMULA:
For 1000g
Zinc oxide, finely sifted
15Ogm
Gelatin
150gm
Glycerol
350gm
Water
FORMULATION
1. The preparation is designed to be re-melted before application as dressing for varicose ulcers and similar lesions.
2. The gel reforms on cooling and the zinc oxide acts as an absorbent and mild astringent.
PROCEDURE:
1. Heat the water to boiling, remove from the heat, add the gelatin and stir gently to dissolve.
2.Add the glycerol, previously heated to 100C but no higher, and stir gently to avoid incorporating air bubbles until
solution is complete.
3.Adjust the base to weight by evaporation or by adding hot water as required.
4.Sift zinc oxideand add in small amounts to the molten base.
5.Continue stirring without aeration until the preparation is viscous enough to hold the powder in suspension but still
pourable.
6.Pour into a suitable vessel (usually a shallow tray) and allow to set.
THEORY
INHALATION:
DEFINITION:
This type of therapy has been used for delivery of drugs through nasal mucosa as well as through the oral cavity for buccal
absorption. Inhalation therapy is now being used for drugs to be delivered to the blood stream and finally to the desired site
of action. Proteins (insulin), steroids, cardiac agents, immunizing agents etc. are being developed for delivery in this
manner.
CHARACTERISTICS FEATURES:
Drugs administered via the inhalation therapy can be delivered either orally or nasally.
These products can be developed as a nebulizer/atomizer, dry powder inhalers, nasal inhaler, metered dose aerosol
inhaler.
Topical pharmaceutical aerosol can be formulated as a spray, foam and semisolid and can be used to deliver
therapeutic agents topically to the skin surface, rectally and vaginally. They consist of a liquid, emulsion and a
semisolid concentrate and liquefied gas or compressed gas propellant.
PACKAGING:
Two methods have been used to package aerosol products depending on the nature of product concentrate. The aerosol can
be filled by a cold-filling or pressure-filling process.
APPLICATIONS:
Aerosol technology has been applied to the formulation of products containing therapeutically active ingredients. These
may also be used as vehicle e.g., sterile water for inhalation, USP and NaCl inhalation USP.
DEVICES FOR INHALATION:
Devices used are termed as inhalers. They include;
Date:
EXPERIMENT#
OBJECT:
To prepare and dispense 25 ml of Menthol inhalation.
FORMULA
Menthol
1.0 g
THEORY
OINTMENT
DEFINITION:
Ointments are semisolid preparation intended for application to the skin with or without inunction. they may be
oleaginous e.g., white ointment; they may be entirely free of oleaginous substances e.g., polyethylene glycol ointment,
or they may be emulsions of fatty or wax like material containing relatively high proportion of water e.g., hydrophilic
ointment.
ACCORDING TO PENETRATION:
1. Epidemic ointment
2. Endodermic ointment
3. Diadermic ointment
CLASSIFICATION ACCORDING TO CHEMICAL COMPOSITION:
PHYSICAL CLASSIFICATION:
They may be classified into four main groups:
1.
Hydrocarbon Bases
2.
Absorption Bases
3.
4.
1.
2.
3.
4.
1.
hydrocarbon
2.
alcohol
3.
acid
4.
ester
5.
soaps
6.
miscellaneous
ACCORDING TO USES OR THERAPEUTIC CLASSIFICATION:
1.
Emollient
2.
Protective
3.
Anti Infectives
4.
Anti Eczematic
5.
Keratolytic
6.
Anti Prespirants
7.
Anti Sebhorrics
METHOD OF PREPARATION:
MIXING BY FUSION:
The constituents of the base are melted together in the basin and stirred gently after melting until cool.
Any foreign particles that are naked on melting cam be removed by decantation or by using a warm muslin cloth.
If product is granular after cooling due to separation of some ingredients of high MP, it may be remelted with min.
heat and restirred until cold.
Stock bases can be made successfully by pouring the melted mixture into a warmed jar, covering and allowing to
stand, undisturbed on a non-conducting surface, until set. (paraffin, simple or wool alcohol ointments of B.P.)
Completely or partially soluble solids should be added in fine powder to the molten base at very low temperature
and the mixture stirred until cold.
Liquids such as methyl salicylate and coal tar solutions and semi solids such as ichthammol should be added just
as the base is thickening, at about 40C. When a solid is soluble in liquid ingredient, (menthol in methyl salicylate), its
more convenient to add it in solution.
Insoluble solids (calamine, starch, zinc oxide) should be passed through a 180 um sieve and added in small
amount while stirring to melted base, when it shows first sign of thickening. Sedimentation should be prevented.
If the product has liquid paraffin or a fixed oil, small amount can be used to levigate powder before adding to base
to produce a smoother product.
MIXING BY TRITURATION:
This is applicable when medicament is a solid insoluble in base or a liquid present in small amount.
Solids should be finely powdered and passed via sieve. (250 um/180 um/125 um mesh).
Trituration can be carried out with an ointment tile and a spatula or using mortar and pestle.
TRITURATION USING TILE AND SPATULA:
Tiles should be large enough to prepare ointments.
Spatula should be flexible and have a broad, non-tapering long blade, to provide a large rubbing surface.
Powders for incorporation are placed on the tile and mixed gently.
Dispersion is then diluted with increasing amounts of base, doubling the quantity on each addition.
The mortar should have a flat base and the pestle is flat headed to give best results.
EXPERIMENT#
OBJECT:
To prepare and dispense 25 gm of Calamine ointment
FORMULA
Calamine, finely sifted
White soft paraffin
1.50 g
8.50 g
PROCEDURE
1. Triturate the calamine powder with part of the white soft paraffin until smooth.
2. Add gradually sufficient quantity of white soft paraffin to produce 10 g.
STORAGE:
Preserve in a well-closed container.
USES:
Astringent and protective.
THEORY
CREAMS
In USPXVIII ,creams are defined as
semisolid emulsions of either oil in water or water in oil type.
semisolid emulsions usually medicated ,intended for external application.
TYPES OF CREAMS:
Cosmetic creams:All purpose cream, baby cream, barrier cream, bleaching cream, cleansing cream cold cream,
hair cream, hand cream, vanishing cream.
Medicated creams:
Creams are reserved for external preparation.
A cream may be water in oil or oil in water depending on the emulsifying agent used.
They are soft easy to apply,cooling to skin ,easily water-removable.
Incorporation Of Liquids:
Non-volatile ,miscible liquids: may be mixed with molten cream in evaporating basin. if a pre-prepared base is used then
follow procedure for volatile or immiscible liquids.
Volatile or immiscible liquids:
E.gs coal tar should be triturated with creams on tile .a very small amount of creams should be placed on tile and a well
made in centre. small quantities are folded gently to avoid splashing.
Diluted creams:
If the diluents is stated in the manufacturer data sheet
Freshly prepared
References:
Compounding and Dispensing by Christopher A Langley & Dawn Belcher pg. 65-91.
Compounding and Dispensing by john F. Marriot, Keith A. Wilson Christopher A Langley & Dawn Belcher
pg.147-151
Pharmaceutical Practice by D M Collett pg:116-117
Sprowls American Pharmacy pg:273-274
Pharmaceutics practice by Winfield.
Date:
EXPERIMENT#
OBJECT:
To prepare and dispense 10 gm of cold cream
FORMULA
Cetyl ester wax
White wax
Mineral oil
Sodium borate
Purified water
12.5 g
12.0g
56.0g
0.5 g
19.0g
PROCEDURE
1. Reduce size of cetyl esters wax and white wax.
2. Melt them on a steam bath with the mineral oil and continue heating until the temperature of the mixture reaches
70C (A).
3. Dissolve sodium borate in purified water and heat at 70C in separate flask (B).
4. Gradually add aqueous solution (B) to the mixture of oily phase (A) with continuous and rapid stirring until it has
congealed.
STORAGE:
Preserve in a well-closed container.
USES:
Emollient and cleansing cream.
THEORY
PRESCRIPTION INCOMPATIBILITY
Definition
When two or more ingredients of a prescription are mixed together the undesired change that may take place in the
physical, chemical or therapeutic properties of the medicament is termed as incompatibility.Pharmaceutical
incompatibility may occur not only during compounding and dispensing but also at any stage during compounding and
dispensing but also at any stage during formulation, manufacturing, packing or administration of drugs.
Classification
Incompatibilities are of three types:
1.
Therapeutic incompatibility
2.
Physical incompatibility
3.
Chemical incompatibility
1) THERAPEUTIC INCOMPATIBILITY
Usually this incompatibility arises when one or more drugs produces response or intensity different from that intended in the
patients.
Classification
A) Over doses
B) Under doses
C) Improper consumption by the patient
D) Contra-indicated drugs
2)PHYSICAL INCOMPATIBILITY
Usually, this is due to immiscibility or insolubility. It can cause unsightly, non-uniform products from which removal of an
accurate dose is very difficult.
Classification:
(A) Immiscibility
(B) Insolubility
(C)Liquefaction
(D)Precipitation
(A) Immiscibility
1) Oils are immiscible with water and hence combination of oily drugs with water produces a product possessing two
separate layers.
Remedy: This problem can be overcome by emulsification or solubilization.
2) Care must be taken when concentrated hydroalcoholic solutions of volatile oils such as spirits and concentrated
waters, are used as adjuncts (e.g. as flavouring agents) in aqueous preparations. Large globules of oils may be separated.
Remedy: To prevent the formation of large globules, the hydroalcoholic solution should either be gradually diluted with the
vehicle before admixture with the remaining ingredients or poured into the vehicle with constant stirring.
3)Addition of high concentrations of electrolytes to mixture in which the vehicle is a saturated aqueous solution of a volatile
oil causes the oil to separate and collect as a surface layer.
e.g.This happens in Potassium Citrate Mixture B.P.C. in which large quantity of soluble solids salts out the lemon oil.
Remedy: To disperse the droplets evenly, quillaia tincture is added as a wetting agent.
(B) Insolubility
1)Liquid preparations containing indiffusible solids such as chalk, aromatic chalk powder, succinyl sulfathiazole and
sulphadimidine (in mixtures) and calamine and zinc oxide (in lotions) - a thickening agent is necessary to obtain a uniform
product from which uniform doses can be removed.
2)Some insoluble powders such as sulphur and certain corticosteroids (hydrocortisone acetate) and antibiotics are difficult to
wet with water.
Remedy: Wetting agents e.g. saponins for sulphur containing lotionsand polysorbates in parenteral suspensions of
corticosteroids and antibiotics are used to distribute the powder and prevent formation of a slowly dispersing, solid
stabilised foam on shaking.
3)When a resinous tincture is added to water the water insoluble resin agglomerate forming indiffusible clots.
Remedy: This is prevented by slowly adding the undiluted dispersion of protective colloid (Tragacanth mucilage).
e.g.Lobelia&Stramonium tincture which should be mixed with Tragacanth mucilage and stirred constantly. This will
produce a stable preparation.
4)High concentrations of electrolytes cause cracking of soap emulsions (ionic) by salting out the emulsifiers.
C) Liquefaction
When certain low melting point solids are powdered together a liquid or soft mass is produced due to lowering of the
melting point of the mixture to below room temperature. Thus a eutectic mixture is formed
D) Precipitation
A drug in solution may be precipitated, if the solvent in which it is insoluble is added to the solution .Example: The resins
are insoluble in water. When the tincture containing resins is added in water, resinagglomerates forming indiffusible
precipitates.This can be prevented by slowly adding theundiluted tincture with vigorous stirring to the dilutedsuspensionOr
By adding some suitable thickening agent.
4)CHEMICAL INCOMPATIBILITY
Intentional:When the prescriber knowingly prescribes theincompatibility drugs.
Unintentional:When the prescriber prescribes the drugswithout knowing that there is incompatibilitybetween the prescribed
drugs.
PRECIPITATE YIELDING INTERACTIONS
The precipitate form through the chemical incompatibility may be diffusible or in-diffusible. The method A and B is
followed in dispensing the prescription yielding diffusible and in-diffusible precipitates respectively.
METHOD (A)
The method is followed when diffusible precipitates are formed in very small quantity. Divide the vehicle into two equal
portions. Dissolve one of the reacting substances in one of the portion and the other in the other portion. Mix the two
portions by slowly adding one portion to the other by rapid stirring.
METHOD (B)
The method is followed when in-diffusible precipitates are formed in large quantity. Divide the vehicle into two portions.
Dissolve one of the reacting substances in one portion. Weigh a suitable quantity of compound tragacanth powder (2g per
100 ml of finished product) and transfer in a mortar and use part of second portion of vehicle to produce smooth mucilage.
Then add other reacting substances. Mix the two portions by slowly adding one portion to the other with rapid stirring .A
secondary label shake the bottle before use should be fixed on the container whenever method A or method B is followed in
dispensing the prescription.
REFERENCES;
1) Physical-and-Chemical-Incompatibilities#scribd
2)http://phceutics2u.blogspot.in
Date:
EXPERIMENT #
OBJECT:
To determine the incompatibility in the given prescription and to rectify it.
Rx
Cod liver oil
Purified water q.s. to
30 ml
100 ml
Make an emulsion.
TYPE OF INCOMPATIBILITY:
Physical
REASON:
Oil and water are not miscible with each other therefore are incompatible physically.
RECTIFICATION:
Date:
EXPERIMENT #
OBJECT:
To determine the incompatibility in the given prescription and to rectify it.
Rx
Castor oil
4.8 ml
15 ml
Make an emulsion.
Label: At once.
TYPE OF INCOMPATIBILITY:
Physical
REASON:
Oil and water are not miscible with each other therefore are incompatible physically.
RECTIFICATION:
THEORY
LOTION
The term lotion has been used to categorize many topical suspension and emulsions intended for application to the skin
e.g. Calamine lotion. Lotions are not defined specifically in USP, but a broad definition describes them as either liquid or
semi-liquid preparations that contain one or more active ingredient in an appropriate vehicle .Lotions are usually
suspensions of solids in an aqueous medium. Some lotions are, in fact, solutions or emulsions.
PROPERTIES
Lotions may contain antimicrobial preservatives and other appropriate excipients such as stabilizers.
They are intended to be applied to the unbroken skin without friction. Medicated lotions should be applied without
rubbing on skin as the chemicals or ingredients which are present in lotions can produce irritation or damage to skin
Preparations intended for use on broken skin should be free from microbial contamination
It may contain ingredients that provide cooling, soothing, drying and protective properties.
They are more preferred over semi-solid preparations because they have good spread ability, easily washable, not as
greasier as other semi solids.
USES
Antiseptic, antipruritic, astringents, germicides, protectives, to treat skin diseases
PREPARATION
By triturating the ingredients to a smooth paste and then adding remaining liquid phase with trituration.
PACKAGING
Amber fluted glass bottles are used for extemporaneously prepared lotions.
If the preparation is particularly viscous a wide-mouthed jar may be used.
LABELING
SHELF LIFE
REFERENCE
1. Pharmaceutical practice by D.M. Collette
2. Remington-the science and practice of Pharmacy, 21st edition
Date:
EXPERIMENT #
OBJECT:
To prepare and dispense 15 g pre electric shaving lotion.
FORMULAFor 100 g
Menthol
0.1 g
Glycerin12g
Boric acid
2g
Ethanol
85.9 gm
Perfume
2 drops
Color
As required
PROCEDURE:
1. Accurately weigh the ingredients.
2. Now dissolve all ingredients and preservative in water then add glycerine
3. Cool Upto0-50 C.
4. Filter, label and dispense in a suitable dispensing bottle.
STORAGE:
Store in a cool place.
USES:
Denature the shivering effect of electric shaving.
THEORY
POWDERS
DEFINITION
Powders are intimate mixtures of dry, finally divided drugs or chemicals that may be intended for either internal or
external use.
This section will include solid preparations intended for both internal and external use. The following types of preparation
will be considered:
Easy to apply
Pleasant to use
Absorb skin moisture
Decreasing skin friction
Discouraging bacterial growth
Drying action gives cooling effect
DISADVANTAGES
1.
2.
3.
4.
REFERENCE
1. Pharmaceutical Practice By Diana M. Collett
2. Pharmaceutical Practice By A.J Winfeild
3. Cooper and Gunn's Dispensing for Pharmaceutical Students
Date:
EXPERIMENT #
OBJECT:
To prepare and dispense 10 g baby powder.
FORMULA For100 g
Magnesium stearate
5g
Magnesium Carbonate
5g
Talc
87.5 g
Boric acid
2.5 g
Preservative
1usp
Perfume
5 drops
PROCEDURE:
USES:
Adsorbent and antiseptic.
Date:
EXPERIMENT #
OBJECT:
To prepare 10 g tooth powder.
FORMULA:
Calcium carbonate
93.5 g
Hard soap
5g
Saccharin sodium
0.2 g
Peppermint oil
0.4 ml
Cinnamon oil
0.2 ml
Methyl salicylate
0.8 ml
PROCEDURE:
Weigh 93.5 g of calcium carbonate, 5 gm of hard soap and 0.2 g of saccharin sodium. Place them in mortar and reduce the
crystalline substance into fine powder form with the help of pestle.
Add 0.4 ml of peppermint oil, 0.2 ml of cinnamon oil and 0.8 ml of methyl salicylate to powder in the mortar and mix
them well.
After proper mixing, the power is transferred to the center of the paper and packed.
FORMULATION USES:
To clean teeth.
Date:
EXPERIMENT #
OBJECT:
To prepare and dispense 10 g foot powder.
FORMULA For 100 gm
Talc
69 g
Boric acid
11 g
Preservative
1usp
Starch
20 gm
PROCEDURE:
STORAGE:
Store in a cool and dry place.
USES:
Adsorbent and antiseptic.
THEORY
Parts Of Prescription:
A prescription is an instruction from a prescriber to a dispenser. The prescriber is not always a doctor but can also be a
paramedical worker, such as a medical assistant, a midwife or a nurse. The dispenser is not always a pharmacist, but can
be a pharmacy technician, an assistant or a nurse. Every country has its own standards for the minimum information
required for a prescription, and its own laws and regulations to define which drugs require a prescription and who is
entitled to write it. Many countries have separate regulations for opiate prescriptions.
The word prescription stems from the latin term praescriptus. Praescriptus is made up of two latin words, prae- , a prefix
meaning before and scribere, a word root meaning to write. Putting it altogether means to write before.
Present day prescriptions are written in English, with doses given in the metric system.
Parts Of A Prescription
A prescription should consist of the following seven parts:
1. Date.
2. Name of the patient and information as to age.
3. Superscription, or heading.
4. Inscription, or main body of the prescription.
5. Subscription, or directions to the compounder.
6. Signatura, or directions for the patient.
7. Prescriber's name.
A prescription is frequently divided into the superscription, including all above the list of ingredients; the inscription,
including the ingredients and their amounts; the subscription, including all below this, as directions to compounder,
directions for patient, and prescriber's name.
A desirable but not essential part of a prescription is a printed heading, giving the prescriber's name, address, registry
number, and other data of interest to the patient and pharmacist.
Date:
EXPERIMENT #
OBJECT:
To interpret the different parts of given prescription.
Name
Age
Sex
Address
Date
Superscription
Inscription
Subscription
Transcription
Other instructions
Name and
prescriber
signature
of
COMMENTS
THEORY
ENEMAS:
Enemas are oily solution/suspension intended for introduction into rectum.
Types:
1) Cleansing Or Evacuant Enemas:
They evacuate the fecal mass, use in the constipation and usually used in the volume of 1-2 L e.g. ,NaCl enemas, NaHCO 3
enema.
They work by stimulating peristalsis e.g. , soap enemas or by lubricating fecal content e.g., olive oil enemas.
2) Therapeutic Enemas:
They are essential to retain at the site of action for therapeutic purpose. Usually used in volume of not more than 100ml.
Used for systemic effects. e.g., Thiopentane enema used for sedative, diagnosis, anti-inflammatory purposes.
3) Carminative Enemas:
Help in proper diagnosis in case of constipation.
4) Emollient Enemas:
Help in cleansing of bowel, also produce lubricant actions.
5) Return Flow Enemas:
They usually washout along with fecal matter use to treat gaseous exchange problems.
PURPOSE:
GIT x-ray
Child delivery
Expel flatus
To soften feces
CONTAINER:
Enemas are generally dispensed in a single-dose plastic container. Enemas of 3-10ml may be packaged in a tube-shaped or
bellow-shaped micro-enema bottle. Alternatively syringes with a rectal cannula may be used for the small volume enemas as
well. Enemas of 20-100ml are supplied in an enema bottle of 100ml or in an enema bag (both disposable). These primary
packaging provides insufficient light protection. If sufficient light protection is desired (for instance with mesalazine)
syringes, bottles or bags are wrapped in aluminium foil or delivered in box or bag.
PACKAGING AND SHELF LIFE:
The type of material of the primary packaging may negatively influence the shelf life of an enema. Diffusion through the
plastic container and degradation of the container may occur during storage of a solution chloral hydrate in arachis oil
packaged in polyethylene enema bottles or in disposable syringes with a rectal cannula. The shelf-life of this enema is 24
months, packaged in a glass or polyethylene terephthalate bottle, 3 months in a micro-enema bottle and 1 month in a
syringe. During the storage of theophylline rectal solution in disposable syringes with a rectal cannula water evaporates.
After 12 months of storage at room temperature, the evaporation rises to 5%, after 24 months storage to 10%. This cause an
increase in concentration, whereas the administered dose remains almost equal. Therefore, a shorter shelf-life is used, 12
months after filling for the syringe versus 24 months after filling for a micro-enema bottle.
STORAGE:
Enemas in enemas bottle or micro-enema bottles prepared according to standardized formula and which are chemically and
physically stable and preserved may get a shelf-life of 12-months in an un-opened container. The same type of enema
packaged in glass bottle with a dose-pac may be assigned a shelf-life of 24 months and 6-months after opening. Preserved
enemas with an unknown physical and chemical stability cannot be stored in the pharmacy because the usage period and
thereby the shelf-life is maximal 1 month and concerns the closed container. A usage period of 1 month also applied to nonpreserved enemas but until use the patient has to store the closed containers in a refrigerator.
LABELLING:
Enemas are dispensed with a label preferably bearing the text for rectal use only
With a suspension enema shake well before use.
If the enema has to be kept in the refrigerator the label should show the text bring to room temperature before use.Upto 10
ml can be achieved by holding bottle for 5min in warm hands. Larger enemas should be taken out of the refrigerator 3h
before use. If enemas in micro-enema bottles or syringes are dispensed in a carton as secondary package the primary
package provided with a flag label only showing date, name of preparation and shelf life.
References:
1)Practical Pharmaceutics An International Guideline for the Preparation, Care and Use of Medicinal Products by
Yvonne Bouwman, V'Iain Fenton-May, Paul Le Brun 2015.pg-221
2)Ansels Pharmaceutical dosage forms and drug delivery systems by loyd V. Allen , Jr. Nicholas G. Popovich Howard C.
Ansel pg-372.
Date:
EXPERIMENT #
OBJECT:
To prepare Soap enema.
REQUIREMENTS:
Soft soap, purified water
FORMULA:
Soft Soap
5.0g
100.0ml
PROCEDURE:
1. Dissolve weighed amount of soft soap in warm purified water.
2. Add sufficient warm purified water to produce 100.0 ml.
STORAGE:
Preserve in a well-closed container.
USES:
To warned to body temperature before use.
Role
Name Of Excipients
Role