Preparation in Pharmacy of Hospital

Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D

Department of PharmaceuticsFaculty of Pharmacy

Omer Al-Mukhtar UniversityTobruk, Libya.

E-Mail: nanjwadebk@gmail.com

2014/06/21 1Faculty 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

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Definitions

1. 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

2. Manufacturing: Manufacturing is the mass production of compounded prescription products for resale to pharmacies and is regulated by the Food and Drug Administration (FDA)

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Regulation1. 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.

2. 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.

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Requirements for Compounding

1. 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.

2. 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)

3. 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.

4. Source of information: Library at a college of pharmacy, textbooks, Journals, manufacturer's drug product information inserts.

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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

1. Sterile parenteral and ophthalmic solutions: These solutions require special consideration for their preparations.

2. Nonsterile solutions: Include oral, topical and otic solutions

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• Preparations of Solutions:1. 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.

2. If an alcoholic solution is used, the aqueous solution is added to the alcoholic solution.

3. The salt form of the drug and not the free-acid or base form, which both have poor solubility, is used.

4. Flavoring or sweetening agents are prepared ahead of time.

5. 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.

6. The proper vehicle (e.g. syrup, elixir aromatic water, purified water) must be selected.

Compounding of Solutions

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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

1. The insoluble powders are triturated to a fine powder, using a Wedgwood mortar.

2. 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..

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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.

Compounding of Suspension

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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:

1. A mortar and pestle are frequently all the equipment that is needed.

2. Electric mixers and hand homogenizers are useful for producing emulsions after the coarse emulsion is formed in the mortar

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3. 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.

a. Dry gum (continental) method

b. Wet gum (English) method

c. Bottle method

d. 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.

Emulsions

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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

1. Bulk powders, which may be used internally or topically, include dusting powders, douche powders, laxatives, antacids and insufflations powders.

2. After a bulk powder has been pulverized and blended, it should be dispensed in an appropriate container

3. 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.

4. Powder papers are also called divided powders.2014/06/21 12Faculty 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

1. As with the bulk powders, all ingredients are triturated and blended, using geometric dilution.

2. The correct size capsules must be determined by trying different capsule sizes, weighing them and choosing the appropriate size.

3. Prior to filling capsules with the medication, the body and cap of the capsule are separated. Filling is accomplished by using the “punch” method.

4. The capsule is wiped clean of any powder or oil and dispensed in a suitable prescription vial.

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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

1. Tablet triturates are made in special molds consisting of a pegboard and a corresponding perforated plate.

2. 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.

3. The diluent is triturated with the active ingredients.

4. A paste in then made, using the alcohol and water mixture.

5. This paste is spread into the mold, allowed to dry and then punched out of the mold.

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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:

1. Act solely on the surface of the skin to produce a local effect (e.g. antifungal agent)

2. Release the medication, which, in turn, penetrates into the skin (e.g., cortisol cream)

3. Release medication for systemic absorption through the skin (e.g., nitroglycerin)

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• Preparation of ointments, creams, pastes and gels

1. Mixing can be done in a mortar or on an ointment slab

2. Liquids are incorporated by gradually adding them to an absorption-type base, using levigation

3. Insoluble powders are reduced to a fine powder and then added to the base, using geometric dilution

4. Water-soluble substances are dissolved with water and then incorporated into the base.

5. The final product should be smooth (impalpable) and free of any abrasive particles.

Ointments, Creams, Pates and Gels

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Suppositories• General characteristics:

1. 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.

2. Suppositories differ in size and shape and include:

a. Rectal

b. Vaginal

c. Urethral

d. Nasal2014/06/21 17Faculty of Pharmacy, Omer Al-Mukhtar University,

Tobrukl, Libya.

• Methods of preparation and dispensing suppositories

1. 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).

2. Hand-rolled suppositories: required a special technique. With proper technique, it is possible to make a product equal to the molded suppositories.

3. 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.

4. 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.

Suppositories

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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:

1. Proper equipment and supplies.

2. Proper facilities, including a laminar flow clean bench.

3. Proper documentation of all products made.

4. Quality control, including batch sterility testing.

5. Proper storage both at the facility and while the product is in transport to the patients home.

6. Proper labeling of the prescription product.

7. Knowledge of products stability and incompatibilities.

8. Knowledge of all ancillary equipment involved in production or delivery of the medications.

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• Preparation of parenteral products

1. 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.

2. These products must be prepared in a clean room, using aseptic technique (i.e., working under controlled conditions to minimize contamination).

3. 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.

4. 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.

Parenteral products

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THANK YOUe-mail: nanjwadebk@gmail.com

2014/06/21 21Faculty of Pharmacy, Omer Al-Mukhtar University, Tobrukl, Libya.