Chapter 14 into to compounding Flashcards
Definition of compounding
- To mix or combine, 2. To make by combining parts, 3. To intensify by adding new elements
Compounding is the
Practice of extemporaneously preparing medications to meet unique need of an individual patient according to specific order of a prescriber
Incense in compounding comes from
Discontinuation of drugs by manufacturers, removal of drugs from market by FDA, unavailability of drugs in a strength or dose, allergies,
Valuable resources of compounding
Remingtons pharmaceutical sciences, Merck Manual, Merck veterinary manual, trissel’s stability of compounded formulations, drugs facts and comparisons, united stats pharmacopeia, vertically drug handbook, internal journal of compounding pharmacists.
USP
Imports states pharmacopeia
USO regulates
Compounding pharmacy by setting standards for compounding, under guidance of volunteer pharmacy compounding experts, offers resources and support for compounder
USP standards for sterile and non sterile preps are available in chapters
797 and 795
USO 795 provides guidance on
Applying good compounding practices in preparation of non sterile compounded formulations
USP 795 was recently revised to include
Categories of compounding (simple, moderate, complex), new definitions for terms (beyond use date, hazardous drug, stability) criteria for compounding each drug preparation (suitable compounding environment and use of appropriate equipment)
PBCA was founded when
8 of the nations leading pharmacy organizations joined together to create a voluntary quality accreditation designation for compounding
Goals of PCAB
- Improve quality of compounding operations and preps.
- Provide a competitive edge in the marketplace and ability to secure new business.
- Offer validation for compounding pharmacies to meet national standards
- Strengthen community confidence
First step in compounding
Obtain a formula/recipe prepared by a pharmacist that include all necessary ingredients and explicit instructions for the preparer
From the formula/recipe the technician creates a
Worksheet containing a list of active ingredients and excipients and exact amounts needed of each.
Geometric dilution
Technique of starting with the ingredient of the smallest amount and doubling the portion b adding the other ingredients in order of quantity until fully mixed
Procedure 1 & 2 of general compounding process
- Obtain the recipe or formula
2. Write up a compounding worksheet based on the formula
Procedure 3 & 4 of general compounding
- Collect all ingredients and equipment necessary to prepare the compound
- Weigh each ingredient and have the measurements verified by the pharmacist
Procedure 5 & 6 of general compounding process
- Following direction of the formula, prepare the compounded medication
- Package and label the compounded medication in an appropriate container
Procedure 7 & 8 of compounding process
- Have the pharmacist do a final check on the compound
8. Clean the workstation and equipment used
Estimated _% of all prescriptions dispensed in the United States are compounded, thus making this a niche market.
1%
Geometric dilution should mean that the final product is
Even distribution of the active ingredient throughout the final product
Most appropriated dosage form will depend on
The drug and the patient
The patient is probably the most important factor in?
Dosage form
Common dosage forms
Capsules. Liquids, transdermal gels, creams, ointments, suppositories, chewables
Even though compounded are prepared on individual basis the pharmacy still must have a good
Quality assurance
Quality assurance (QA)
A program of activities used to ensure that the procedures used in preps of compounds lead to products that meet certain specifications and standards
Typical components of a good QA program include
SOPs, formulation records, compounding worksheets, ingredient record forms, material safety data sheets, documented training, and QA tests for each compound
Standard operating procedures (SOPs) are
A step by step written instructions on how to do a certain task. All important tasks should be covered by a SOP
SOPs should be developed for
Facility maintenance, equipment calibration and maintenance, personnel training and validation, and preparation, packaging, and storing of compounded items.
SOPs can assure that
Equipment is properly maintained and calibrated, supplies and chemicals are received, inventoried, compliant with compounding standards, stored properly and disposed of correctly, all procedure and tasks are performed consistently and documented
SOP general format follow
- SOP number - unique assigned number
- Date effective
- Author
- Author signature
- Purposes of procedure
- Equipment/ materials listed for each task
- Detailed procedure
- Documentation forms
PCAB accreditation requires SOPs to regard
Cleaning, maintenance, calibration and verification of each piece of equipment
Capsules:
Oral dosage, been used for more than a century. Offers broad range of dosage options for patients.
Tablets:
Solid dosage form administered orally, sublingually, vagina lily or as an implant under the skin. Compressed tables made by manufacturers are most commonly prescribed dosage form.
Sublingually means
Under the tongue, preparations may be administered by placing them under the tongue and allowing them to dissolve.
Powder is a
Solid dosage form made from blended active ingredients and excipients.
Lozenge is a
Solid dosage form administered orally to be dissolved in the mouth
Trachea is a
Interchangeable term for lozenge but sometimes prepared in soft form
Suppository is a
Solid dosage form used to administer medication by way of the rectum, vagina, or urethral tract
Aqueous solutions are
Water soluble
Powders are a solid dosage that may be used
Either internally (BC powder) or externally (talcum powder). Use of powders has declined, but still an occasional need.
Some advantages of using torches and lozenges are that they
Easily to handle and administer to a variety of patients, base is made of sugar torches generally have a pleasant taste which makes them popular with pediatric, geriatric, and hospice patients.
Sticks :
Unique dosage form used for topical application of local anesthetic, sunscreens, antivirals, antibiotics, and cosmetics. Convenient, relatively stable and fairly easy to repair but time consuming.
A suppository dissolves
At body temperatures, allowing absorption of medication into surrounding tissues. Can have a systemic effect or local effect depending on desired effect expected by prescriber or on the drug being used.
Common bases for suppositories
Battibase, poly base, cocoa butter
Drug in a suppository can either be
Dissolved or suspended
Solutions:
Water soluble chemical dissolved in the water phase of compounding. May contain just enough water to dissolve the drug or may be as much as 50% of the final volume.
Suspensions:
Preparation that contains insoluble solid particles uniformly dispersed though-out a vehicle. Must be shaken prior to administration.
Suspensions need a suspending agent such as
Ora plus or Karo syrup
Emulsions:
Liquid or semisolid preparation that can be taken orally or applied topically.
Emulsions are prepaired when
Two immiscible liquids must be dispensed in the same preparation
Emulsions are held together by a
Emulsifying agent
Emulsions are either
Water-in-oil or oil-in-water
Internally oil-in-water
Topical could be both
Ointments:
Semisolid, usually applied to skin or mucosal tissue. Doe not penetrate into the skin, should be soft and easily spreadable and smooth in texture.
Common ointment bases are
Hydrophilic petrolatum, aquaphor, hydrous ianolin, and PEG ointments.
Comminuting or triturating
Process of reducing particle size to a fine powder
Pastes:
Stiff or very viscous, do not melt or soften at body temp. Intended as protective covering over areas where applies. (Diaper rash)
Cream:
Soft, opaque solid applied externally. Dissipate into skin healing the affected area from inner layers of dermis. Medications are usually dissolved or suspended in water soluble base.
Some cream bases available include
Vanishing cream, HRT base, cetaphil, Eucerin, lubriderm
Gels:
Semisolid system consisting of suspensions made up of small inorganic particles or large organic molecules interpenetrated by a liquid.
Transdermal gel
Unique, semisolid dose that becoming increasingly popular. Have special absorption enhancers that “push” medication though the layers of skin so it can be absorbed into the blood stream.
Most common form of transdermal gel is a
Two phase vehicle made from plutonic lecithin organogel (PLO) consists of both oil phase and an aqueous phase. Making it suitable for many chemicals/
Poloxamer gel is a
Liquid stored in the fridge. When brought to room temp it will form a gel. Final product should be stored at room temp.
Ophthalmic preps:
For the eye. May be a solution, suspension, or ointment. Must be sterile.
Ophthalmic solutions must be
Clear and particulate free, and is the most commonly prepared in compounding
The eye generally tolerates a pH rang of
4 to 11
Buffers are used to
Maintain the pH of a product
Preservatives are necessary when
Prep is intended for multiple uses. They prevent contamination of preparation from microbial growth.
Optic preps:
For the ear, (otic) made in liquid, powder or ointment form.
Vehicles most often used for otic liquids are
Propylene glycol, glycerin, polyethylene glycol, vegetable oil, mineral oil. Necessary to use viscous liquid because medication should adhere to the ear canal.
Nasal preps:
Solutions, suspensions, gels, or ointments. Used locally or systemically.
Excipients used in nasal preps could be
The vehicle, buffers, preservatives, tonicity adjusting agents.
Two common vehicles used for nasal solutions are
Sodium chloride 0.9% and sterile water for injection
Veterinary compounding:
One of the fastest growing areas of compounding. Doses are usually calculated on milligrams per kilogram of body weight. Making for a more accurate dose.
Successfully _____ medication is a critical step in the process, especially when a drug is bitter.
Flavoring
A psychological impact for medication is
Flavor and color
Individuals are usually more sensitive to the
Aroma of a prep then the actual taste. Older patients may require added amounts of flavor. Females tend to be more sensitive to smell then males.
Pediatric flavoring
Children have more taste buds, meaning more sensitive to taste. Infants and children tend to prefer sweet tases and do not respond well to bitter flavors. Flavors could include raspberry, bubblegum, marshmallow, butterscotch, citrus, berry and vanilla. The younger the patient the more mild the flavor should be.
Adult flavoring
More tolerant of bitter flavors such as coffee, chocolate, cherry, anise, grapefruit, mint.
Four taste types
Sour, sweet, bitter, salty and a new fifth sense call umami
Sweet, salty and sour taste receptors are in a region
Just inside the outer edge of the tongue.
Salary and sour receptors are located
Along the back of the tongue
Sour only receptors are located
In the center of the tongue
There is an area in the tongue where no sensation are experienced
Toward the center and front. (Center section)
The brain is not able to distinguish different tastes components rather
Perceives taste as a composite sensation
Most used flavor enhancer is
Vanilla
