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
• Tobruk, Libya.
• E-Mail nanjwadebk_at_gmail.com

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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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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.

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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 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.

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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
• Sterile parenteral and ophthalmic solutions
  These solutions require special consideration for
  their preparations.
• Nonsterile solutions Include oral, topical and
  otic solutions

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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.

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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
• 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..

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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.

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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
• 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

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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.

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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
• 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.

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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.

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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
• 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.

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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
• 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)

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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.

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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

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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.

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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
• 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.

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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.

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THANK YOUe-mail nanjwadebk_at_gmail.com