1. Preparation in Pharmacy of Hospital
Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D
Department of Pharmaceutics
Faculty of Pharmacy
Omer Al-Mukhtar University
Tobruk, Libya.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

2. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
CONTENTS
Definitions
Regulation
Requirements for compounding
Compounding of solutions
Compounding of suspension
Emulsion
Powdered dosage forms
Capsuleslets (Tablet triturates)
Molded tab
Ointments, Creams, Pastes and Gels
Suppositories
Parenteral products
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

3. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Definitions
Extemporaneous compounding: Extemporaneous compounding is the preparation, mixing, assembling, packing and labeling of a drug product based on a prescription order from a licensed practitioner for the individual patient
Manufacturing: Manufacturing is the mass production of compounded prescription products for resale to pharmacies and is regulated by the Food and Drug Administration (FDA)
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

4. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Regulation
Current Good Manufacturing Practices (cGMP): cGMP are standards of practice used in the pharmaceutical industry and are regulated by the FDA. Community pharmacists must comply with cGMP but must also assure a quality product, which includes using proper materials, weighing equipment, a documented technique and dispensing and storage instruction.
Legal considerations:
a. Extemporaneous compounding by the pharmacist of a prescription order from a licensed practitioner as with the dispensing of any other prescription is controlled by the state board of registration in pharmacy.
b. The legal risk (liability) of compounding is no greater than filling a prescription for a manufactured product as the pharmacist must assure that the correct drug, dose and directions are provided. The pharmacist is also responsible for preparing a quality pharmaceutical product, providing proper instructions regarding its storage and advising the patient of any adverse effects.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

5. Requirements for Compounding
Sources for chemicals and drugs: Pharmacists must obtain small quantities of the appropriate chemicals or drugs from wholesalers. These wholesalers then act as consultants to the pharmacist by assuring them of their product’s purity and quality.
Equipment: The correct equipment is also important when compounding. Many state boards of pharmacy have a required minimum list of equipment for compounding prescriptions. Suggested equipment, which varies according to the amount of material needed and the type of compounded prescription (e.g., parenteral)
Location of compounding area: Many pharmacies actively involved in compounding have dedicated a separate area in the pharmacy to this process. The ideal location is away from heavy foot traffic and is near a sink where there is enough space to work and store all chemicals and equipment.
Source of information: Library at a college of pharmacy, textbooks, Journals, manufacturer's drug product information inserts.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

6. Compounding of Solutions
Definition: A solution as a liquid preparation that contains one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents. Although the uniformity of the dosage in a solution can be assumed, the stability, pH, solubility of the drug or chemicals, taste (for oral solutions) and packaging need to be considered.
Types of solutions
Sterile parenteral and ophthalmic solutions: These solutions require special consideration for their preparations.
Nonsterile solutions: Include oral, topical and otic solutions
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

7. Compounding of Solutions
Preparations of Solutions:
Each drug chemical is dissolved in the solvent in which it is most soluble. Thus, the solubility characteristics of each drug or chemical must be known.
If an alcoholic solution is used, the aqueous solution is added to the alcoholic solution.
The salt form of the drug and not the free-acid or base form, which both have poor solubility, is used.
Flavoring or sweetening agents are prepared ahead of time.
If the required chemical or drug is in bulk or powder from, then the particle size is reduced first, using a mortar and pestle, a sieve or other suitable means.
The proper vehicle (e.g. syrup, elixir aromatic water, purified water) must be selected.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

8. Compounding of Suspension
Definition: Suspensions are defined by the USP as liquid preparations that consist of solid particles dispersed throughout a liquid phase in which the particles are not soluble.
Preparation of suspensions
The insoluble powders are triturated to a fine powder, using a Wedgwood mortar.
A small portion of liquid is used as levigating agent and the powders are triturated until a smooth paste is formed. The levigating agent is added slowly and mixed deliberately..
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

9. Compounding of Suspension
3. The vehicle containing the suspending agent is added in divided portions. A high-speed mixer greatly increases the dispersion. 4. The product is brought to the required volume using the vehicle. 5. The final mixture is transferred to a “tight” bottle for dispensing to the patient. 6. All suspension are dispensed with a “shake well” label. 7. Suspensions are never filtered. 8. The water-soluble ingredients are mixed, including flavoring agents, in the vehicle before mixing with the insoluble ingredients.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

10. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Emulsions
Definition: Emulsions are produced by a two-phase system in which one liquid is dispersed throughout another liquid in the form of small droplets.
Preparation of emulsion:
A mortar and pestle are frequently all the equipment that is needed.
Electric mixers and hand homogenizers are useful for producing emulsions after the coarse emulsion is formed in the mortar
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

11. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Emulsions
The order of mixing of ingredients in an emulsion depends on the type of emulsion being prepared (i.e., O/W or W/O) as well as the emulsifying agent chosen. Methods used for compounding include the following.
Dry gum (continental) method
Wet gum (English) method
Bottle method
Beaker method
4. Preservatives: If the emulsion is kept for an extended period of time, refrigeration is usually sufficient. The product should not be frozen. If a preservative is used, it must be soluble in the water phase to have any effect.
5. Flavoring agents: If the addition of a flavor is needed to mask the taste of the oil phase, the flavor should be added to the oil before emulsification.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

12. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Powdered Dosage Forms
Definition: Powders are dry mixtures of drugs or chemicals intended for internal or external use. The two major types are powder papers and bulk powders.
Preparation of powder dosage forms
Bulk powders, which may be used internally or topically, include dusting powders, douche powders, laxatives, antacids and insufflations powders.
After a bulk powder has been pulverized and blended, it should be dispensed in an appropriate container
Eutectic mixtures of powders can cause problems since they liquify. One remedy is to add an inert powder, such as magnesium oxide, to separate the eutectic materials.
Powder papers are also called divided powders.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

13. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Capsules
Definition: Capsules are solid dosage forms in which the drugs is enclosed within a hard or soft soluble container or shell made form suitable gelatin. Hard gelatin capsules may be manually filled for extemporaneous compounding.
Preparation of hard and soft capsules
As with the bulk powders, all ingredients are triturated and blended, using geometric dilution.
The correct size capsules must be determined by trying different capsule sizes, weighing them and choosing the appropriate size.
Prior to filling capsules with the medication, the body and cap of the capsule are separated. Filling is accomplished by using the “punch” method.
The capsule is wiped clean of any powder or oil and dispensed in a suitable prescription vial.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

14. Molded Tablets (Tablet Triturates)
Definition: Tablet triturates are molded tablets made of powders created by moistening the powder mixture with alcohol and water. They are used for compounding potent drugs in small doses.
Formulation and preparation of tablet triturates
Tablet triturates are made in special molds consisting of a pegboard and a corresponding perforated plate.
In addition to the mold, a diluent, usually of lactose and sucrose (80/20), and a moistening agent, usually a mixture of ethyl alcohol and water (60/40) are required.
The diluent is triturated with the active ingredients.
A paste in then made, using the alcohol and water mixture.
This paste is spread into the mold, allowed to dry and then punched out of the mold.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

15. Ointments, Creams, Pates and Gels
General characteristics: These dosage forms are semisolid preparations generally applied externally.
Semisolid dosage forms may contain active drugs intended to:
Act solely on the surface of the skin to produce a local effect (e.g. antifungal agent)
Release the medication, which, in turn, penetrates into the skin (e.g., cortisol cream)
Release medication for systemic absorption through the skin (e.g., nitroglycerin)
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

16. Ointments, Creams, Pates and Gels
Preparation of ointments, creams, pastes and gels
Mixing can be done in a mortar or on an ointment slab
Liquids are incorporated by gradually adding them to an absorption-type base, using levigation
Insoluble powders are reduced to a fine powder and then added to the base, using geometric dilution
Water-soluble substances are dissolved with water and then incorporated into the base.
The final product should be smooth (impalpable) and free of any abrasive particles.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

17. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Suppositories
General characteristics:
Suppositories are molded solid dosage forms intended for insertion into a body cavity. They are used to deliver drugs for their local or systemic effects.
Suppositories differ in size and shape and include:
Rectal
Vaginal
Urethral
Nasal
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

18. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Suppositories
Methods of preparation and dispensing suppositories
Molded suppositories: are prepared by first melting the base and then incorporating the medications uniformly into the base. This mixture is then poured into the suppository mold (fusion method).
Hand-rolled suppositories: required a special technique. With proper technique, it is possible to make a product equal to the molded suppositories.
Containers: for the suppositories are determined by the method and base in preparation. Hand-rolled and molded suppositories should be dispensed in special boxes that prevent the suppositories from coming in contact with each other.
Storage conditions: If appropriate, a “refrigerate” label appear on the container. Regardless of the base or medication used in the formulation, the patient should be instructed to store the suppositories in a cool dry place.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

19. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Parenteral products
General requirements. The extemporaneous compounding of sterile products is no longer confined only to the hospital environment; it now is done by community pharmacists engaged in home care practice. Minimum requirements include:
Proper equipment and supplies.
Proper facilities, including a laminar flow clean bench.
Proper documentation of all products made.
Quality control, including batch sterility testing.
Proper storage both at the facility and while the product is in transport to the patients home.
Proper labeling of the prescription product.
Knowledge of products stability and incompatibilities.
Knowledge of all ancillary equipment involved in production or delivery of the medications.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

20. Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.
Parenteral products
Preparation of parenteral products
Preparation of sterile products requires special skills and training. Attempts to prepare parenteral products or provide this service without proper training should not be made.
These products must be prepared in a clean room, using aseptic technique (i.e., working under controlled conditions to minimize contamination).
Dry powders of parenteral drugs for reconstitution are used for drug products that are unstable as solutions. It is important to know the correct diluents that can be used to yield a solution.
Solutions of drugs for parenteral administration may also be further diluted prior to administration. If further dilution is required, then the pharmacist must know the stability and compatibility of the drug in the diluent.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.

21. THANK YOU e-mail: nanjwadebk@gmail.com
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.