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CONTEMPORARY PHARMACEUTICAL COMPOUNDING. Loyd V. Allen, Jr., Ph.D., R.Ph. Editor-in-Chief International Journal of Pharmaceutical Compounding. Role of the Compounding Pharmacist. “Individualizing Drug Therapy”. IJPC First Issue Cover. OUTLINE. Introduction Compounded Pharmaceuticals

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contemporary pharmaceutical compounding

CONTEMPORARY PHARMACEUTICAL COMPOUNDING

Loyd V. Allen, Jr., Ph.D., R.Ph.

Editor-in-Chief

International Journal of Pharmaceutical Compounding

role of the compounding pharmacist
Role of the Compounding Pharmacist
  • “Individualizing Drug Therapy”
outline
OUTLINE
  • Introduction
  • Compounded Pharmaceuticals
  • U.S. Pharmacopeia
  • FDA and Contemporary Compounding
  • Current USP Compounding Activities
  • New Drug Delivery Systems
  • Summary
introduction
INTRODUCTION
  • History of Pharmacy Compounding in the United States
  • Reasons for the Growth of Compounding
  • Special Patient Populations
  • Examples of Pharmaceutical Compounding
history of pharmacy compounding in the u s
History of Pharmacy Compounding in the U.S.
  • In the past, Compounding Was Pharmacy
  • 1900s gave way to commercially prepared pharmaceuticals
  • Many strengths/dosage forms available
  • Economics changed all that
  • Limited strengths/dosage forms
  • “One Size Fits All” approach
reasons for the growth of pharmacy compounding
Reasons for the Growth of Pharmacy Compounding
  • Limited dosage forms
  • Limited strengths
  • Home health care
  • Hospice
  • Nonavailable drug products/combinations
    • Discontinued Drugs
    • Drug Shortages
  • Orphan drugs
  • Veterinary compounding
  • New therapeutic approaches
  • Special Patient Populations
special patient populations
SPECIAL PATIENT POPULATIONS
  • Pediatrics
  • Geriatrics
  • Bioidentical Hormone Replacement Therapy
  • Pain Management
  • Dental Patients
  • Environmentally & Cosmetic Sensitive
  • Sports Injuries
  • Veterinary Compounding
    • Small, Large, Herd, Exotic, Companion
meeting patients needs
MEETING PATIENTS NEEDS
  • Traditional Dosage Forms
  • New Dosage Forms
compounded dosage forms
COMPOUNDED DOSAGE FORMS

Oral Solids (Capsules, Tablets)

Oral Liquids (Solutions, Susp, Emulsions)

Topicals (Creams, Ointments, Gels)

Suppositories, Inserts

Injectables

Many, many others….

newer compounded dosage forms
NEWER COMPOUNDED DOSAGE FORMS
  • Oral
  • Topical
  • Parenteral
  • Specialty
rapid dissolving tablets
RAPID-DISSOLVING TABLETS
  • Active Drug qs
  • Lactose 70 mg
  • PEG 3350 30 mg
  • Actual size depends upon mold.
  • ‘Bridging’ mechanism
gummy gels
GUMMY GELS
  • Fentanyl citrate 1.884 mg
  • Chewable gummy gel base 23.35 g
  • Bentonite 500 mg
  • Aspartame 500 mg
  • Acacia powder 500 mg
  • Citric acid monohydrate 650 mg
  • Flavor concentrate 10-12 drops
veterinary oral paste
VETERINARY ORAL PASTE
  • Ingredient #1 #2 #3 #4
  • PEG 300 65 25 - -
  • PEG 3350 35 25 25 -
  • Prop Glycol - 50 25 -
  • Molasses - - 50 -
  • Peanut Butter - - - 65
  • Hydrog Veg Oil - - 35
oral pastes
ORAL PASTES
  • VANCOMYCIN PASTE
  • (VANC PASTE)•
  • Vancomycin 500 mg
  • Aspartame 200 mg
  • Flavor qs
  • Sodium benzoate 200 mg
  • Methylcellulose 2% Gel qs100 mL
lollipops
LOLLIPOPS
  • Sodium chloride 46.56 g
  • Potassium chloride 3 g
  • Calcium lactate 6.12 g
  • Magnesium citrate 2.04 g
  • Sodium bicarbonate 22.44 g
  • Sodium phosphate monobasic 3.84 g
  • Silica gel 3.6 g
  • Flavor qs
  • PEG 1450 qs
popsicles
POPSICLES
  • NYSTATIN POPSICLES•
  • -------------------------------------------
  • Nystatin powder 2,500,000 u
  • Sorbitol 70% solution 20 mL
  • Syrup 50 mL
  • Flavoring (banana, etc.) 5 mL
  • Purified water qs 300 mL
troches lozenges
TROCHES/LOZENGES
  • TESTOSTERONE 2 MG TROCHES•
  • Testosterone 24 mg
  • Citric acid 300 mg
  • Stevia powder 250 mg
  • Saccharin sodium 30 mg
  • Polyethylene glycol 1450 20 g
  • Citrus flavor qs
sublingual drops
SUBLINGUAL DROPS
  • TESTOSTERONE 10 mg/0.1 mL SL •
  • Testosterone 1 g
  • Saccharin 100 mg
  • Silica gel 200 mg
  • Tangerine oil qs
  • Almond oil qs 10mL
topical plo gels
TOPICAL PLO GELS
  • PROMETHAZINE HCL 50 mg/mL PLO GEL •
  • -------------------------------------------------Promethazine HCl 5 g
  • Purified water 4 mL
  • Lecithin:Isopropyl palmitate 22 mL
  • Pluronic F127 30% Gel qs 100 mL
topical plo gels1
TOPICAL PLO GELS
  • Capsaicin 75 mg
  • Ketamine HCl 2 g
  • Ketoprofen 10 g
  • Ethoxy diglycol 10 mL
  • Lecithin:Isopropyl palmitate 22 mL
  • Pluronic F127 30% gel qs 100 mL
rapid penetrating topicals
RAPID-PENETRATING TOPICALS
  • PROGESTERONE 50 mg/mL CLEAR SOLUTION•
  • Progesterone 5 g
  • Benzyl alcohol 20 mL
  • Alcohol, absolute 20 mL
  • DMSO 20 mL
  • Propylene glycol qs 100 mL
lipid crystals cream
LIPID CRYSTALS CREAM
  • ANTHRALIN 1% IN LIPID CRYTALS•
  • Anthralin 1 g
  • Glyceryl laurate 7 g
  • Glyceryl myristate 21 g
  • Citric acid 1 g
  • Sodium hydroxide 140 mg
  • Purified water qs 100 g
ambulatory pump infusion solution
AMBULATORY PUMP INFUSION SOLUTION
  • CEFTAZIDIME 20 mg/mL •
  • -------------------------------------------
  • Ceftazidime 2.5 g
  • Sterile water for injection qs
  • 0.9% Sodium chloride inj qs125 mL
intrathecal injection
INTRATHECAL INJECTION
  • Fentanyl citrate 314 μg
  • Bupivacaine HCl 100 mg
  • Baclofen 500 μg
  • 0.9% Sodium chloride inj. qs 20 mL
sponge disks
SPONGE DISKS
  • VANCOMYCIN SPONGE DISKS•
  • --------------------------------------------
  • Vancomycin HCl 5 mg
  • Sponge (collagen or gelatin) qs
implantable beads
IMPLANTABLE BEADS
  • TOBRAMYCIN IMPREGNATED POLYMETHYLMETHACYLRATE BEADS•
  • --------------------------------------------
  • Tobramycin sulfate 1.2 g
  • Palacos Bone cement 40 g
iontophoretic solution
IONTOPHORETIC SOLUTION
  • Dexamethasone sodium phosphate 400 mg
  • Sterile water for injection qs 100 mL
phonophoresis preparations
PHONOPHORESIS PREPARATIONS
  • HYDROCORTISONE 10% PHONOPHORESIS GEL•
  • Hydrocortisone 10 g
  • Carbopol 940 1.25 g
  • Propylene glycol 15 mL
  • Methylparaben 200 mg
  • Propyleparaben 100 mg
  • Purified water qs 100 mL
  • Sodium hydroxide 10% Sol qs
u s pharmacopeia

U.S. PHARMACOPEIA

Setting Standards for Drugs in the U.S. since 1906

pharmacopeia
Pharmacopeia
  • Pharmakon drug
  • poiein to make
  • Used together in Pharmacopeia means any recipe or formula or other standards required to make or prepare a drug.
  • 1580 Bergamo, Italy…..first used in connection with a local book of drug standards.
pharmacopeias
Pharmacopeias
  • Local, City and National Pharmacopeias in Europe
  • The London, Edinburgh and Dublin Pharmacopeias were official until 1864
  • Replaced by the British Pharmacopoeia
  • How about in the U.S.?
pharmacopoeias of the u s
Pharmacopoeias of the U.S.
  • 1778 Lititz Pharmacopeia
    • First Pharmacopeia in the U.S.
    • Published in Lititz, Pennsylvania for use by the Military Hospital of the U.S. Army
  • 1808 Massachusetts Medical Society
    • published a 272 page pharmacopeia with information on 536 drugs and preparations
pharmacopoeias of the u s1
Pharmacopoeias of the U.S.
  • Jan 1817 Dr. Lyman Spalding
      • Submitted a plan
      • Medical Society of the County of New York
      • Creation of a national pharmacopeia
      • ----
      • Divided U.S. into 4 geographical districts
      • Medical schools and societies were to develop a
      • pharmacopeia and appoint delegates to a general convention to be held in Washington, DC
pharmacopoeias of the u s2
Pharmacopoeias of the U.S.
  • Jan 1820 First U.S. Pharmacopeial Convention
    • Only 2 districts submitted plans
    • These were reviewed, consolidated and adopted.
  • Dec 1820 First U.S. Pharmacopeia was published
    • 272 pages containing 217 drugs/preparations
usp i
USP I
  • Preface:(in part)
  • It is the object of the Pharmacopeia to select from among substances which possess medicinal power, those, the utility of which is most fully established and best understood; and to form from them preparations and compositions, in which their powers may be exerted to the greatest advantage……..
u s pharmacopeia and fdama
U.S. PHARMACOPEIA AND FDAMA
  • 1985 USP Convention
    • Resolution 4
      • Compounding Information in the USP
    • Resolution 5
      • Standards for Repackaged and Compounded Parenterals
  • 1990 USP Convention
    • Established the Expert Advisory Panel on Pharmacy Compounding
resolution 4
Resolution #4
  • Be it resolved that the COR examine the desirability and feasibility of developing, with a view to inclusion in the USP, the following types of information:
  • 1. The short-term stability of drugs when dissolved in common diluents and stored in common standardized containers and/or delivery systems at room, refrigerator and freezer temperatures;
resolution 4 cont d
Resolution #4 (cont’d)
  • 2. pKa and minimum solubility of drugs in common diluents; and
  • 3. pH, osmolality and osmolarity of reconstituted injectables and liquid dosage forms.
resolution 5
Resolution #5
  • Be it resolved that the COR be charged with the responsibility for providing standards and test methods; specifications for packaging, labeling, and storage; guidelines for appropriate documentation; and, where necessary, procedures for compounding parenteral preparations.
psd subcommittee
PSD Subcommittee
  • Expert Advisory Panel on Pharmacy Compounding was formed to advise the PSD Subcommittee
  • Also, the Review Panel on Pharmacy Compounding Practices was formed to assist the Expert Advisory Panel by providing immediate expert review on materials produced by the Panel
expert advisory panel
Expert Advisory Panel
  • Oct 1993 First meeting
  • Organized into 2 groups
    • General Chapter Group
      • to prepare a general informational chapter on compounding
    • Monograph Group
      • develop monographs for specific preparations
        • those widely compounded but not available commercially
u s pharmacopeia and fdama1
U.S. PHARMACOPEIA AND FDAMA
  • 1993-2000 Expert Advisory Panel Activities
  • I. General Chapter Group
    • <795> Pharmacy Compounding
  • II. Monograph Group
    • develop monographs for specific preparations
fda activities
FDA ACTIVITIES
  • Mid 1990s FDA began investigating a number of pharmacies that were compounding large quantities of selected drug products.
  • Manufacturing under the guise of compounding
  • “New Drugs”
food and drug administration activities
Food and Drug Administration Activities
  • FDA considered compounded preparations as “New Drugs” and subject to the New Drug Provisions
    • IND
    • NDA
    • Safety
    • Efficacy
  • Enforcement Activities
fdama 97 passage
FDAMA 97 Passage
  • Pharmacy professional organizations
  • U.S. Congress
  • FDAMA 97
  • Compounding provisions
food and drug administration modernization act
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • New Drug Requirements
    • shall not apply to a drug product if the drug product is compounded for an individual patient based on the unsolicited receipt of a valid prescription order…..if the compounding is by:
    • a licensed pharmacist
    • a licensed physician
food and drug administration modernization act1
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • Anticipatory Compounding
  • Physician-Patient-Pharmacist “Triad”
food and drug administration modernization act2
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • Compounding must be done using the following sources of ingredients:
  • USP/NF monographs
  • Commercial products
  • Bulk Drug Substances List (being developed)
food and drug administration modernization act3
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • Compounding cannot be done from:
  • Drugs on the “Negative List”
    • drugs that have been withdrawn due to safety or efficacy reasons
    • List was developed
food and drug administration modernization act4
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • Cannot compound regularly or in inordinate amounts any drug products that are essentially copies of commercially available products
food and drug administration modernization act5
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • Cannot compound a drug product that “presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety and effectiveness of that drug product”. (list)
food and drug administration modernization act6
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • Memorandum of Understanding
    • Distribution of inordinate amounts interstate
    • Handling of complaints
food and drug administration modernization act7
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT
  • Advertising
    • The pharmacy, pharmacist or physician cannot advertise or promote the compounding of any particular drug, class of drug, or type of drug.
fda modernization act of 1997
FDA Modernization Act of 1997
  • FDA Advisory Committee on Compounding
  • Function: to advise the FDA in the areas of bulk drug substances, safety and efficacy and difficult-to-compound products.
  • FDA Pharmacy Compounding Steering Committee (Internal to FDA)
fda modernization act of 1997 three lists
FDA Modernization Act of 1997Three Lists
  • Products not to be compounded because they were withdrawn from the market based on safety and efficacy concerns
  • Bulk drug substances of proven quality accepted for use in pharmacy compounding
  • Difficult-to-compound products
implementation of fdama
IMPLEMENTATION OF FDAMA
  • Ongoing since 1997
  • FDA Steering Committee (Internal)
  • FDA Compounding Advisory Committee (External)
  • Work with USP
usp i1
USP I
  • Preface:(in part)
  • It is the object of the Pharmacopeia to select from among substances which possess medicinal power, those, the utility of which is most fully established and best understood; and to form from them preparations and compositions, in which their powers may be exerted to the greatest advantage……..
fdama implementation and the usp
FDAMA IMPLEMENTATION AND THE USP
  • <1161>Pharmacy Compounding Practices became <795 Pharmacy Compounding
  • Monographs of accepted bulk drug substances are being developed
  • <1206> Sterile Preparations-Pharmacy Practices has been recommended as guidelines for sterile preparations compounding…being renumbered as <797>
  • New chapters being written
usp 2000 2005
USP 2000-2005
  • New structure from Committee of Revision to Expert Committees
  • Compounding Pharmacy Expert Committee
    • General Chapters, incl <795>
    • Nonsterile preparation monographs
  • Parenteral Products--Compounding and Preparation Expert Committee
    • General Chapters, incl <1206>
    • Sterile preparation monographs
usp convention 2000
USP Convention 2000
  • Resolution
  • Continue to develop and institute, in collaboration with other organizations as appropriate, specific initiatives focused on the development of appropriate compounding guidelines and monographs for non-commercially available, but commonly prescribed, medicines and dosage forms for use in special populations, notably neonatal, pediatric, geriatric, and terminally ill patients.
u s pharmacopeia and fdama2
U.S. PHARMACOPEIA AND FDAMA
  • Activities to date:
  • 15 official compounding monographs
  • 8 more stability studies underway
  • 6 formulas being processed through PF
  • 2 official chapters and 2 additional chapters in process:
    • Pharmacy Calculations
    • Good Compounding Practices
current activities of pharmacy compounding expert committee
CURRENT ACTIVITIES OF PHARMACY COMPOUNDING EXPERT COMMITTEE
  • Survey of compounding pharmacists in hospitals, community pharmacies and long-term care facilities (August 2000)
  • List of over 150 preparations, mostly pediatric, that need to be considered.
  • 2000 Resolution:
u s pharmacopeia1
U.S. PHARMACOPEIA
  • 2001
  • Recent survey listed over 1000 other preparations need monographs
  • Well over 5,000 different formulations routinely compounded
fdama and the 9th district
FDAMA and the 9th District
  • Early 2001
    • the Ninth Circuit ruled that the FDAMA section dealing with compounding was invalid in the 9th Circuit District (NV, CA, WA, OR, MT, ID, AZ, AK, HI) but still in effect in the rest of the US.
fdama and the 9th district1
FDAMA and the 9th District
  • April 29, 2002
  • U.S. Supreme Court ruled the advertising restrictions unconstitutional and the section not severable.
  • Entire 503a now is thrown out and nonenforceable
summary
SUMMARY
  • Pharmacy compounding is now legally recognized by the FDA, the Supreme Court, Congress, etc. as a necessary component of quality health care
  • Emphasis on quality of compounding is increasing with documentation of quality being recommended and required
  • Clinical pharmacy becomes more of a reality with compounding pharmacy
a look into the near future

A LOOK INTO THE NEAR FUTURE

New Compounded Drug Delivery Systems (DDS)

future trends
Future Trends
  • Adhesive Site-Specific DDS
  • Antibody-Based DDS
  • Biocompatible Microsphere DDS
  • Biodegradable Polymers DDS
  • Biologic-Based DDS
  • Electromagnetic/Radiation- Activated DDS
future trends1
Future Trends
  • Immunomodulator DDS
  • Implant-Enhanced DDS
  • Microorganism-Containing Microcapsule DDS
  • Lipid Microcylinders
  • Liposome Enhancements
  • Living-Cell Therapies
future trends2
Future Trends
  • Magnetic System DDS
  • Maze-Escape DDS
  • Monoclonal Antibody DDS
  • Novel Nasal DDS
  • New Osmotic DDS
  • Transmucosal DDS
  • Polymer Drug Complex DDS
future trends3
Future Trends
  • Pulsatile DDS
  • Resealed Erythrocyte DDS
  • Respiratory DDS
  • Self-Assembling Controlled-Release DDS
  • Programmed Skin-Surface DDS
nanotechnology
NANOTECHNOLOGY
  • The art and science of building molecular structures so they are sufficiently large and complex to function as machines or devices
  • Atomically precise, functional machine systems developed on the scale of the nanometer
  • Builds objects atom by atom, molecule by molecule
potential products
POTENTIAL PRODUCTS
  • Activated Pharmaceuticals (Magic Bullets)
  • Cell-herding machines to stimulate rapid wound healing
  • Nanosurgeons to repair damaged cellular parts
  • Nanocruisers to attack viruses and bacteria
forecasts 2 5 years
FORECASTS: 2-5 YEARS
  • Inexpensive handheld biosensors built on the basis of nanoscale ion channel switches
  • Simple detection of diseases, within minutes, from a small sample of saliva or blood
forecasts
FORECASTS
  • DNA vaccines will begin to be available in the next 5-10 years
  • Superior and safer than traditional vaccines
  • Ability to directly mimic body components and can “rebuild” worn, defective, damaged, diseased cells/tissues/organs
  • Blood products, artificial skin products, bioartificial organs, blood vessels
forecasts1
FORECASTS
  • IF a breakthrough to a universal assembler occurs during the next 10-15 years, an entirely new field of “nanomedicine” and “nanopharmacy” will emerge by 2020.
nanomedicine
NANOMEDICINE
  • Monitoring, repair, construction and control of human biological systems at the molecular level, using engineered nanodevices and nanostructures.
nanopharmacy
NANOPHARMACY

Preparation and delivery of ultra-small pharmaceuticals, therapeutic substances and delivery systems.

nanopharmacy and nanopharmaceuticals
NANOPHARMACY AND NANOPHARMACEUTICALS
  • Motors consisting of, for example, ATPase molecules with a metallic substrate and a chemical “propeller” on the other. As the ATP breaks down, the biomotor moves.
  • This motor may be able to compound tiny quantities of drugs and pump them directly to the target tissues.
nanopharmacy and nanopharmaceuticals1
NANOPHARMACY AND NANOPHARMACEUTICALS
  • The uses of biomolecular motors could be used for sensing or placing in living cells as a pharmacy to deliver medicine when required.
nanopharmacy and nanopharmaceuticals2
NANOPHARMACY AND NANOPHARMACEUTICALS
  • New formulations and routes for drug delivery
  • Pharmaceuticals based on an individuals genome
conclusions
CONCLUSIONS
  • We must live in today and prepare for tomorrow
  • Compounding pharmacists roles in “individualizing drug therapy” is preparing the foundation for the “NANOPHARMACY” of tomorrow.
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