Download Preparations in Pharmacy of Hospital

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.
E-Mail: [email protected]
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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CONTENTS
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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.
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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)
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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Regulation
1.
2.
a.
b.
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:
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.
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.
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Requirements for Compounding
1.
2.
3.
4.
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.
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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
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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Compounding of Solutions
• Preparations of Solutions:
1.
2.
3.
4.
5.
6.
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.
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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..
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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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.
9
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
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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Emulsions
3.
a.
b.
c.
d.
4.
5.
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
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.
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.
11
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
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
12
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.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
13
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.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
14
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)
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
15
Ointments, Creams,
Pates and Gels
• 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.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
16
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. Nasal
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
17
Suppositories
• 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.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
18
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.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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Parenteral products
• 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.
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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THANK YOU
e-mail: [email protected]
2014/06/21
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobrukl, Libya.
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