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Preparation in Pharmacy of Hospital

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Preparation in Pharmacy of Hospital Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics Faculty of Pharmacy Omer Al-Mukhtar University – PowerPoint PPT presentation

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Title: Preparation in Pharmacy of Hospital


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.
  • E-Mail nanjwadebk_at_gmail.com

2
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

3
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)

4
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.

5
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 products
    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.

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

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.

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..

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.

10
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

11
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.

12
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.

13
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.

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.

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)

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.

17
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

18
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.

19
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.

20
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.

21
THANK YOU e-mail nanjwadebk_at_gmail.com
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