Basic Principles of Compounding Dispensing
Pharmaceutical dispensing:
Dispensing is that part of the practice of Pharmacy in which the pharmacist or a Pharmacy technician under his supervision interprets that doctor's requirements for the drug treatment of his patient.
Or,
Dispensing means to prepare and supply medicine to an individual in accordance with the prescription of a practitioner.
General dispensing procedure:
I) Work on your own
ii) Wear a freshly laundered overall coat.
iii) Provide your self with clean materials
like glass cloth, duster, sponge, etc
iv) Work in a clean tidy manner
v) Read the prescription carefully
vi) Check the doses of internal preparations
vii)Work out your calculations
viii)Check the labels and fix them in a
container
ix) Wrap the container
x) Make the appropriate records.
Fundamental operations in compounding and dispensing:
- Compounding and dispensing is concerned
- with the preparation of medicines from the
- basic ingredients on a small scale.
- Weighing
- Measurement of liquids
- Dissolution
- Filtration
- Mixing
- Size
- reduction
- size
- separation
Current Good Manufacturing Practices(cGMP) and Current Good Compounding Practices(cGMP):
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Current Good Compounding Practices:
In recent years, pharmacists have increased the practice of compounding patient-specific medications. A number of reasons have been presented for the increase in preparing patient-specific medications, including the following:
1. Many patients need drug dosages or strengths that are not commercially available.
2. Many patients need dosage forms, such as suppositories, oral liquids, or topicals, that are not commercially available.
3. Many patients are allergic to excipients in commercially available products.
4. Children’s medications must be prepared as liquids, flavored to enhance compliance, and prepared in alternative dosage forms, such as lozenges, gumdrops, popsicles, and lollipops.
5. Some medications are not very stable and require preparation and dispensing every few days; they are not suitable to be manufactured products.
6. Many physicians desire to deliver products in innovative ways, and pharmacists can work with them to solve medication problems.
7. Most products are not available for veterinary patients and must be compounded.
8. Home health care and the treatment of an increasing number of patients at home have resulted in many community pharmacies and home health care pharmacies preparing sterile products for home use.
9. Hospice care has resulted in new approaches to pain management and higher concentrations and combinations of drugs that are now used.
10. Many drugs are reported in the literature but are not yet manufactured, so pharmacists can compound them for their physicians’ and patients’ use.
As the extent of compounding increased, many standard-setting agencies and regulatory bodies wanted to ensure quality compounded products; consequently, there was a lot of activity during the mid-1990s to establish guidelines for pharmaceutical compounding.
Containers and closures for dispensed products:
Packaging
The packaging is the process by which the pharmaceuticals are suitably packed so that they 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 that seals the container to exclude oxygen, carbon dioxide, moisture, micro-organisms, and prevents the loss of volatile substances.
It also prevents the loss of medicament during transport and handling.
The qualities of good containers and. closures/ideal properties of containers and closures :
• An ideal container must meet the following criteria.
• It must preserve the physical properties of all dosage forms and protect them against damage or breakage.
• It should protect the contents from physical and mechanical hazards. These include vibration, compression, shock, puncture, abrasion, etc.
• It must protect the product against undesirable or adulterating chemical, biological or physical entities.
• It should protect the contents from the atmospheric factors. For e.g. oxygen, Carbon dioxide.
• It should protect the contents from the loss of product due to leakage, spillage, or permeation.
• It should not interact with the contents. This includes migration, absorption, adsorption, or extraction.
• It should protect the contents from the loss of water and volatile materials.
• The container must not impart its own color, test, or odor to the preparation.
• It should be capable of withstanding extremes of temperature and pressure as well as to withstand
handling while empty, while filling, closing, sterilizing, labeling, transport, storage and use by the
customer.
• It must not alter the identity of the product.
• The container and closure must not react either with each other or with the preparation.
• The closure must be easy to remove and replace.
• The cost of the container and closure is an integral part of the overall cost of the preparation, so it should
not be high.
• Apart from all these a container and closure should be attractive in appearance and must have a sale
promotion and marketing value.
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 includes.
i)Accurate: The label should be checked immediately after writing and again before fixing it to the container.
ii)Legible: It should be easily readable, it should be either typewritten or printed.
iii)Intelligible: The information given on the label should be completely unambiguous (t) and arranged to avoid any confusion.
iv) 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
i. Indicate clearly the patient, for whom it has been prescribed.
ii) Indicate the name and address of the supplier and the date of supply.
iii. In most of the cases give precise details as to the contents of the container when dispensed.
iv. State the storage condition and shelf life of the medicine.
v) Give clear and complete instruction to the patient on how and when to take or use the preparation.
i. Indicate clearly the patient, for whom it has been prescribed.
The patient's title, forename (নামের প্রথম অংশ ), initial name, or surname (পদবী) should appear on the label of each medicine dispensed.
ii. 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.
iii. In most of the cases give precise details as to the contents of the container when dispensed. This includes
The quantity in the container: The total quantity of the product dispensed in the container should be indicated on the label.
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 a non-proprietary name is used.
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.
Units: Wherever possible quantities should be expressed as whole numbers of units. e.g. 100 mg rather than 1gm.
• Batch identification: The batch reference should be included in the labeling (UK).
• Diluted products: Particular care should be taken when labeling medicines prepared by the dilution of more concentrated products.
iv. State the storage condition and shelf life of the medicine.
This includes..
Temperature: A large number of products need to be stored in a cool place. e.g. suppositories.
• Humidity: Solid unit dosage forms should be protected from moisture. (Air +moisture proof container)
• Light: Light-sensitive products should be stored in amber-colored containers.
• Sources of ignition: Products containing a large proportion of flammable ingredients should be labeled "flammable" and keep away from naked flames.
•Shelf life: The period during which the quality of medicine is expected to remain within acceptable limits.
v. Give clear and complete instruction to the patient on how and when to take or use the preparation.
This Includes
• Directions: Includes quantity to be taken or amount to be used, frequency and timing of application, route of administration, etc.
• Shake the bottle: Emulsion, suspension, etc.
• Take with water: Mixtures that can cause gastric irritation. E.g. Disprin(Aspirin)
Over-the-Counter labeling:
• The product’s active ingredients, including the amount in each dosage unit
• The purpose of the product
• The uses (indications) for the product
• Specific warnings, including when the product should not be used under any circumstances and when it is appropriate to consult with a doctor or pharmacist. This section also describes side effects that could
occur and substances or activities to avoid.
• Dosage instructions—when, how, and how often to take the product
• The product’s inactive ingredients and important information to help consumers avoid ingredients that may cause an allergic reaction.
*Storage:
To ensure the stability of a pharmaceutical preparation for the period of its intended shelf life, the product must be stored in proper conditions. The labeling of each product includes the desired conditions of storage. The terms generally employed in such labeling have meanings defined by the USP :
Cold: Any temperature not exceeding 8°C (46°F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2°C and 8°C (36°F and 46°F). A freezer is a cold place in which the temperature is maintained thermostatically between − 25°C and − 10°C (− 13°F and 14°F).
Cool: Any temperature between 8°C and 15°C (46°F and 59°F). An article for which storage in a cool place is directed may alternatively be stored in a refrigerator unless otherwise specified in the individual monograph. Room temperature: The temperature prevailing in a working area. A controlled room temperature encompasses the usual working environment of 20°C to 25°C (68°F to 77°F)
but also allows for temperature variations between 15°C and 30°C (59°F and 86°F) that may be found in pharmacies, hospitals, and drug warehouses.
Warm: Any temperature between 30°C and 40°C (86°F and 104°F).
Excessive heat: Above 40°C (104°F).
Protection from freezing: Where in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.
Basic principles of Compounding
Batch manufacturing record(BMR)
A batch manufacturing record is a written document from the batch that is prepared during the pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and whole manufacturing process step by step.
The guidelines should cover the process used during the manufacturing process and how to handle and equipment used.
...
The first page should show the following:
Batch number.
Composition.
Size and weight.
Storage conditions.
Master formula of the batch.
Start and completion date and expiry date.
Manufacturer's license number.
*Dispensing both should be clean as a sop.
*Dispensing accessories clean.
*Area clean as per sop
*Electronic scale weighing clean
*Age & equipment
