CONTEMPORARY PHARMACEUTICAL COMPOUNDING

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

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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 Drug qs • Lactose 70 mg • PEG 3350 30 mg • Actual size depends upon mold. • ‘Bridging’ mechanism

16. Compounded Gummy Bears

17. 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

18. 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

19. ORAL PASTES • VANCOMYCIN PASTE • (VANC PASTE)• • Vancomycin 500 mg • Aspartame 200 mg • Flavor qs • Sodium benzoate 200 mg • Methylcellulose 2% Gel qs100 mL

20. Compounded Lollipops

21. 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

22. Compounded Popsicles

23. 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

24. 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

25. 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

26. Compounded PLO Gels

27. 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

28. 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

29. 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

30. 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

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33. Compounding Parenterals

34. AMBULATORY PUMP INFUSION SOLUTION • CEFTAZIDIME 20 mg/mL • • ------------------------------------------- • Ceftazidime 2.5 g • Sterile water for injection qs • 0.9% Sodium chloride inj qs125 mL

35. Ambulatory Pumps

36. INTRATHECAL INJECTION • Fentanyl citrate 314 μg • Bupivacaine HCl 100 mg • Baclofen 500 μg • 0.9% Sodium chloride inj. qs 20 mL

37. SPONGE DISKS • VANCOMYCIN SPONGE DISKS• • -------------------------------------------- • Vancomycin HCl 5 mg • Sponge (collagen or gelatin) qs

38. IMPLANTABLE BEADS • TOBRAMYCIN IMPREGNATED POLYMETHYLMETHACYLRATE BEADS• • -------------------------------------------- • Tobramycin sulfate 1.2 g • Palacos Bone cement 40 g

39. IONTOPHORETIC SOLUTION • Dexamethasone sodium phosphate 400 mg • Sterile water for injection qs 100 mL

40. Iontophoresis Unit

41. Iontophoresis Unit

42. Iontophoresis Unit

43. Inside Iontophoresis Unit

44. Size of a Dupel Iontophoresis Unit

45. 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

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 • 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.