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CONTEMPORARY PHARMACEUTICAL COMPOUNDING Loyd V. Allen, Jr., Ph.D., R.Ph. Editor-in-Chief International Journal of Pharmaceutical Compounding.

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Presentation on theme: "CONTEMPORARY PHARMACEUTICAL COMPOUNDING Loyd V. Allen, Jr., Ph.D., R.Ph. Editor-in-Chief International Journal of Pharmaceutical Compounding."— Presentation transcript:

1 CONTEMPORARY PHARMACEUTICAL COMPOUNDING Loyd V. Allen, Jr., Ph.D., R.Ph. Editor-in-Chief International Journal of Pharmaceutical Compounding

2 Role of the Compounding Pharmacist Individualizing Drug Therapy

3 IJPC First Issue Cover


5 OUTLINE Introduction Compounded Pharmaceuticals U.S. Pharmacopeia FDA and Contemporary Compounding Current USP Compounding Activities New Drug Delivery Systems Summary

6 INTRODUCTION History of Pharmacy Compounding in the United States Reasons for the Growth of Compounding Special Patient Populations Examples of Pharmaceutical Compounding

7 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

8 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

9 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


11 ..

12 MEETING PATIENTS NEEDS Traditional Dosage Forms New Dosage Forms

13 COMPOUNDED DOSAGE FORMS Oral Solids (Capsules, Tablets) Oral Liquids (Solutions, Susp, Emulsions) Topicals (Creams, Ointments, Gels) Suppositories, Inserts Injectables Many, many others….

14 NEWER COMPOUNDED DOSAGE FORMS Oral Topical Parenteral Specialty

15 RAPID-DISSOLVING TABLETS Active Drugqs Lactose70 mg PEG mg Actual size depends upon mold. Bridging mechanism

16 Compounded Gummy Bears

17 GUMMY GELS Fentanyl citrate1.884 mg Chewable gummy gel base23.35 g Bentonite500 mg Aspartame500 mg Acacia powder500 mg Citric acid monohydrate650 mg Flavor concentrate10-12 drops

18 VETERINARY ORAL PASTE Ingredient#1#2#3#4 PEG PEG Prop Glycol Molasses--50- Peanut Butter---65 Hydrog Veg Oil--35

19 ORAL PASTES VANCOMYCIN PASTE (VANC PASTE) Vancomycin500 mg Aspartame200 mg Flavorqs Sodium benzoate200 mg Methylcellulose 2% Gelqs100 mL

20 Compounded Lollipops

21 LOLLIPOPS Sodium chloride46.56 g Potassium chloride3 g Calcium lactate6.12 g Magnesium citrate2.04 g Sodium bicarbonate22.44 g Sodium phosphate monobasic3.84 g Silica gel3.6 g Flavorqs PEG 1450qs

22 Compounded Popsicles

23 POPSICLES NYSTATIN POPSICLES Nystatin powder2,500,000 u Sorbitol 70% solution20 mL Syrup50 mL Flavoring (banana, etc.)5 mL Purified waterqs300 mL

24 TROCHES/LOZENGES TESTOSTERONE 2 MG TROCHES Testosterone24 mg Citric acid300 mg Stevia powder250 mg Saccharin sodium30 mg Polyethylene glycol g Citrus flavorqs

25 SUBLINGUAL DROPS TESTOSTERONE 10 mg/0.1 mL SL Testosterone1 g Saccharin100 mg Silica gel200 mg Tangerine oilqs Almond oilqs10 mL

26 Compounded PLO Gels

27 TOPICAL PLO GELS PROMETHAZINE HCL 50 mg/mL PLO GEL Promethazine HCl5 g Purified water4 mL Lecithin:Isopropyl palmitate 22 mL Pluronic F127 30% Gelqs 100 mL

28 TOPICAL PLO GELS Capsaicin75 mg Ketamine HCl2 g Ketoprofen10 g Ethoxy diglycol10 mL Lecithin:Isopropyl palmitate 22 mL Pluronic F127 30% gelqs 100 mL

29 RAPID-PENETRATING TOPICALS PROGESTERONE 50 mg/mL CLEAR SOLUTION Progesterone5 g Benzyl alcohol20 mL Alcohol, absolute20 mL DMSO20 mL Propylene glycolqs100 mL

30 LIPID CRYSTALS CREAM ANTHRALIN 1% IN LIPID CRYTALS Anthralin1 g Glyceryl laurate7 g Glyceryl myristate21 g Citric acid1 g Sodium hydroxide140 mg Purified waterqs100 g

31 ...


33 Compounding Parenterals

34 AMBULATORY PUMP INFUSION SOLUTION CEFTAZIDIME 20 mg/mL Ceftazidime2.5 g Sterile water for injectionqs 0.9% Sodium chloride injqs125 mL

35 Ambulatory Pumps

36 INTRATHECAL INJECTION Fentanyl citrate314 μg Bupivacaine HCl100 mg Baclofen500 μg 0.9% Sodium chloride inj. qs 20 mL

37 SPONGE DISKS VANCOMYCIN SPONGE DISKS Vancomycin HCl5 mg Sponge (collagen or gelatin)qs


39 IONTOPHORETIC SOLUTION Dexamethasone sodium phosphate400 mg Sterile water for injectionqs 100 mL

40 Iontophoresis Unit



43 Inside Iontophoresis Unit

44 Size of a Dupel Iontophoresis Unit

45 PHONOPHORESIS PREPARATIONS HYDROCORTISONE 10% PHONOPHORESIS GEL Hydrocortisone10 g Carbopol g Propylene glycol15 mL Methylparaben200 mg Propyleparaben100 mg Purified waterqs100 mL Sodium hydroxide 10% Solqs

46 Compounding Oral Inhalation Solutions

47 Compounded Oral Inhalation Solutions

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

49 Pharmacopeia Development

50 Pharmacopeia Pharmakondrug poieinto make Used together in Pharmacopeia means any recipe or formula or other standards required to make or prepare a drug Bergamo, Italy…..first used in connection with a local book of drug standards.

51 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.?

52 Pharmacopoeias of the U.S. 1778Lititz Pharmacopeia –First Pharmacopeia in the U.S. –Published in Lititz, Pennsylvania for use by the Military Hospital of the U.S. Army 1808Massachusetts Medical Society –published a 272 page pharmacopeia with information on 536 drugs and preparations

53 Pharmacopoeias of the U.S. Jan 1817Dr. 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

54 Pharmacopoeias of the U.S. Jan 1820First U.S. Pharmacopeial Convention –Only 2 districts submitted plans –These were reviewed, consolidated and adopted. Dec 1820First U.S. Pharmacopeia was published –272 pages containing 217 drugs/preparations

55 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……..


57 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

58 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;

59 Resolution #4 (contd) 2. pKa and minimum solubility of drugs in common diluents; and 3. pH, osmolality and osmolarity of reconstituted injectables and liquid dosage forms.

60 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.

61 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

62 Expert Advisory Panel Oct 1993First 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

63 U.S. PHARMACOPEIA AND FDAMA Expert Advisory Panel Activities I. General Chapter Group – Pharmacy Compounding II. Monograph Group –develop monographs for specific preparations


65 FDA ACTIVITIES Mid 1990sFDA began investigating a number of pharmacies that were compounding large quantities of selected drug products. Manufacturing under the guise of compounding New Drugs

66 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

67 FDAMA 97 Passage Pharmacy professional organizations U.S. Congress FDAMA 97 Compounding provisions

68 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

69 FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT Anticipatory Compounding Physician-Patient-Pharmacist Triad

70 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)

71 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

72 FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT Cannot compound regularly or in inordinate amounts any drug products that are essentially copies of commercially available products

73 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)

74 FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT Memorandum of Understanding –Distribution of inordinate amounts interstate –Handling of complaints

75 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.

76 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)

77 FDA Modernization Act of 1997 Three 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

78 IMPLEMENTATION OF FDAMA Ongoing since 1997 FDA Steering Committee (Internal) FDA Compounding Advisory Committee (External) Work with USP

79 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……..

80 FDAMA IMPLEMENTATION AND THE USP Pharmacy Compounding Practices became <795 Pharmacy Compounding Monographs of accepted bulk drug substances are being developed Sterile Preparations-Pharmacy Practices has been recommended as guidelines for sterile preparations compounding…being renumbered as New chapters being written

81 Current USP Compounding Activities

82 USP New structure from Committee of Revision to Expert Committees Compounding Pharmacy Expert Committee –General Chapters, incl –Nonsterile preparation monographs Parenteral Products--Compounding and Preparation Expert Committee –General Chapters, incl –Sterile preparation monographs

83 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.

84 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

85 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 Resolution:

86 U.S. PHARMACOPEIA 2001 Recent survey listed over 1000 other preparations need monographs Well over 5,000 different formulations routinely compounded


88 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.

89 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

90 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




94 A LOOK INTO THE NEAR FUTURE New Compounded Drug Delivery Systems (DDS)

95 Future Trends Adhesive Site-Specific DDS Antibody-Based DDS Biocompatible Microsphere DDS Biodegradable Polymers DDS Biologic-Based DDS Electromagnetic/Radiation- Activated DDS

96 Future Trends Immunomodulator DDS Implant-Enhanced DDS Microorganism-Containing Microcapsule DDS Lipid Microcylinders Liposome Enhancements Living-Cell Therapies

97 Future Trends Magnetic System DDS Maze-Escape DDS Monoclonal Antibody DDS Novel Nasal DDS New Osmotic DDS Transmucosal DDS Polymer Drug Complex DDS

98 Future Trends Pulsatile DDS Resealed Erythrocyte DDS Respiratory DDS Self-Assembling Controlled-Release DDS Programmed Skin-Surface DDS

99 NANOTECHNOLOGY: The Ultimate Alchemy

100 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

101 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

102 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

103 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

104 FORECASTS IF a breakthrough to a universal assembler occurs during the next years, an entirely new field of nanomedicine and nanopharmacy will emerge by 2020.

105 NANOMEDICINE Monitoring, repair, construction and control of human biological systems at the molecular level, using engineered nanodevices and nanostructures.

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

107 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.

108 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.

109 NANOPHARMACY AND NANOPHARMACEUTICALS New formulations and routes for drug delivery Pharmaceuticals based on an individuals genome

110 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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