Extemporaneous Preparations
Updated 5/19/2002

Ganciclovir, regular	Ganciclovir, sugar-free	Valganciclovir
MMF regular	MMF sugar-free	Pantoprazole (Protonix®)
Tacrolimus	Amphotericin B

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Amphotericin B Oral Suspension
Dentinger PJ, Swenson CF, Anaizi NH. Stability of amphotericin B in an extemporaneously compounded oral suspension. Am J Health Syst Pharm. 2001; 58(11):1021-4.
Ingredients
Ampho B powder (Medisca)	10 grams
Carboxymethylcellulose 1% solution	50 mL
Citric Acid	0.75 grams
Methylparaben (10%) / Propylparaben (2%) in propylene glycol	1 mL
Na2HPO4 (anhydrous)	1.59 grams
NaH2PO4 (anhydrous)	0.96 grams
Na Benzoate	0.1 grams
Na metabisulfite	0.15 grams
Glycerin	15 mL
Cherry flavor	0.4 mL
Sterile H2O for irrigation .……. QSAD	100 mL
Final concentration =100 mg/mL
Method
Dissolve the Na salts plus the citric acid in approx 40 mL of water Add the carboxymethylcellulose and while mixing warm at low heat. Mix until uniform While mixing add the parabens solution dropwise very slowly, allowing the parabens to dissolve before adding the next drop. Mix the cherry flavor with glycerin and add to the above. Work the ampho b powder to a smooth paste with a portion of the above solution, and then incorporate the remainder of the solution. Adjust the pH of the mixture to 5.3 with citric acid solution (200 mg/mL) Add enough sterile water for irrigation to make 100 mL and mix gently. Label "shake well", "protect from light", and give 60 day expiration.

Ganciclovir Oral Suspension
Anaizi N, Swenson C, and Dentinger P. Stability of ganciclovir in extemporaneously compounded oral liquid preparations. Am J Health-syst Pharm 1999; 56: 1738-41
Because of the potential risk of teratogenicity from this drug, it is prudent to avoid unnecessary exposure through either skin contact or inhalation of dust. Precautionary measures such as using a fume (or vertical-laminar-airflow) hood and wearing latex gloves are recommended. If a fume hood is not available, it is advised to wear a surgical mask while at the same time minimizing the creation of dust.
Ingredients
Ganciclovir 250-mg capsules	----------------------------	20,000 mg
Sterile water for irrigation	----------------------------	30 mL
Ora-Sweet Vehicle (Regular or Sugar-Free)	QSAD   ---------------------	200 mL
Final concentration = 100 mg/mL
Method
Empty the contents of 80 250-mg ganciclovir capsules into a glass mortar. The 500-mg capsules should not be used for this purpose since they have not been tested. Add the 30 mL of water to wet the powder and work to a smooth paste. You may also need to add a small amount of the Ora-Sweet Vehicle (or Ora-Sweet Sugar-Free Vehicle) for this purpose. Add 150 mL of the appropriate vehicle in three steps: Add about one third of the vehicle to the paste, mix, and transfer the contents of the mortar to an amber polyethylene tetraphthalate glycol (PETG) bottle which has been previously calibrated to 200 mL with a graduated cylinder. Rinse the mortar with about one third of the vehicle, and transfer the contents to the graduated cylinder. Repeat step b with the last third of the vehicle. Add enough vehicle to bring the final volume to 200 mL, close with a child-resistant cap, and mix. Label the bottle "Shake Well Before Using" and "Use Cytotoxic Drug Precautions." Label with an expiration date of 120 days.

Mycophenolate Mofetil (MMF) Oral Suspension
Anaizi N, Swenson C, and Dentinger P. Stability of mycophenolate mofetil in an extemporaneously compounded oral suspension AJHP '98; 55:926-29 Swenson, Dentinger, and Anaizi. Stability of mycophenolate mofetil in an extemporaneously compounded sugar-free oral liquid. AJHP '99; 56:2224-25
Because of the potential risk of teratogenicity from this drug, it is prudent to avoid unnecessary exposure through either skin contact or inhalation of dust. Precautionary measures such as using a fume (or vertical-laminar-airflow) hood and wearing latex gloves are recommended. If a fume hood is not available, it is advised to wear a surgical mask while at the same time minimizing the creation of dust.
Ingredients
MMF (capsules)	-----------------	20,000 mg
Cherry-Flavored Syrup or Cherry-Flavored Aspartame Syrup	QSAD   -------------	200 mL
Final concentration =100 mg/mL
Method
Empty the contents of 80 250-mg mycophenolate mofetil capsules into a porcelain mortar. Add sufficient cherry-flavored aspartame syrup (see composition below) to wet the powder and levigate to a smooth paste. Add 150 ml of the syrup in three steps: Add about one third of the syrup to the paste, mix and transfer the contents of the mortar to a 250-ml graduated cylinder. Rinse the mortar with about one third of the syrup, and transfer the contents to the graduated cylinder. Repeat step b with the last third of the syrup. Add enough syrup to bring the final volume to 200 ml, and mix. Shake the suspension well, and transfer it to an amber polyethylene terephthalate glycol (PETG) bottle with a child-resistant cap. Label the bottle "Shake Well Before Using", "Refrigerate", and "Use Cytotoxic Drug Precautions." Label with an expiration date of 120 days.
The sugar-free vehicle consists of Ora-Plus oral suspending vehiclea with 0.4 % (v/v) artificial cherry flavorb, 0.05 mg/mL FD&C red dye no. 40c and 3 mg/mL aspartamed (equivalent to approximately 50% sucrose). a Paddock Laboratories, Inc, Minneapolis, MN 55427, lot 7C6939 b Shementon Corp, West Orange, NJ 07052, lot 2454 c Allied Chemical Corp, Morristown NJ 07960, lot Z3828 d Spectrum Quality Products, Inc, Gardena, CA 90246, lot MM0133

Tacrolimus Oral Suspension
Jackobson PA, Johnson CE, West NJ, Foster JA. Stability of tacrolimus in an extemporaneously compounded oral liquid AJHP 1997; 54:178
Because of the potential risk of toxicity, it is prudent to avoid unnecessary exposure through either skin contact or inhalation of dust. Precautionary measures such as using a fume (or vertical-laminar-airflow) hood and wearing latex gloves are recommended. If a fume hood is not available, it is advised to wear a surgical mask while at the same time minimizing the creation of dust.
Ingredients
Tacrolimus (capsules)	-----------------	25 mg
Ora-Plus® suspending agent	-----------------	25 mL
Simple Syrup, NF	QSAD   -------------	50 mL
Final concentration = 0.5 mg/mL
Method
Empty the contents of five 5-mg Prograf® capsules into a glass mortar and work to a smooth paste with a small portion of the Ora-Plus® suspending agent. Add Ora-Plus® gradually and mix well until all the 25 mL of Ora-Plus® are added. Add about 25 mL of Simple Syrup NF to bring the total volume of the suspension to 50 mL Mix well and transfer to an amber polyethylene terephthalate glycol (PETG) bottle. Label the bottle "Shake Well Before Using" and "Use Cytotoxic Drug Precautions." Label with an expiration date of 50 days.

Valganciclovir Oral Suspension
Anaizi N, Swenson C, and Dentinger P. Stability of valganciclovir in extemporaneously compounded oral liquid. Am J Health-syst Pharm 2002; submitted
Because of the potential risk of teratogenicity from this drug, it is prudent to avoid unnecessary exposure through either skin contact or inhalation of dust. Precautionary measures such as using a fume (or vertical-laminar-airflow) hood and wearing latex gloves are recommended. If a fume hood is not available, it is advised to wear a surgical mask while at the same time minimizing the creation of dust.
Ingredients
Valganciclovir (tablets)	-----------------	20250 mg
Sodium benzoate	-----------------	117 mg
Other ingredients	-----------------	see method below
cherry-chocolate vehicle	QSAD   -------------	225 mL
Final concentration = 90 mg/mL
Method
Prepare the oral liquid vehicle by adding 0.6 mL of artificial cherry flavoring to 300 mL of simple syrup and diluting to 500 mL with Hershey's chocolate syrup. Mix well and set aside. Store in the refrigerator, and assign expiration date of one year. Dissolve 117 mg of sodium benzoate in 45 mL of Sterile Water for Irrigation, USP and set aside. It should be noted that the cherry-chocolate vehicle is preserved with 0.06% sodium benzoate. Additional sodium benzoate is added to the product to attain a final concentration of 0.1%. Triturate 45 450-mg valganciclovir (Valcyte*) tablets into a fine powder using a glass mortar and pestle. Slowly add the sodium benzoate solution and levigate the powder into a smooth paste. Make sure all of the film coating dissolves. Add approximately 50 mL the vehicle, mix well, and transfer into a beaker that has been calibrated to 225 mL with a graduated cylinder. Rinse the mortar and pestle with two 50-mL portions of the oral liquid vehicle and transfer each rinse into the beaker. Adjust the pH of the oral liquid to approximately 3.2 using 10 N hydrochloric acid. Add enough cherry-chocolate vehicle to bring the final volume to 225 mL. If necessary add more 10 N hydrochloric acid to adjust the pH to 3.2 Mix well, and transfer the preparation to an amber polyethylene terephthalate bottle with a child-resistant cap. Label the bottle "Refrigerate and Shake Well Before Using" and "Use Cytotoxic Drug Precautions." Label with an expiration date of 34 days.

Pantoprazole Oral Liquid
Dentinger P, Swenson C, and Anaizi N. Stability of pantoprazole in extemporaneously compounded oral liquid. Am J Health-syst Pharm 2002; 59(10):953-56
Ingredients
Pantoprazole (tablets)	-----------------	800 mg
Sodium bicarbonate powder	-----------------	33.6 g
Sterile water for irrigation, USP	QSAD   -----------------	400 mL
Final concentration = 2 mg/mL
Method
Remove the Protonix imprint from each of twenty pantoprazole 40-mg tablets by rubbing the tablets on a paper towel that has been dampened with ethyl alcohol. If the imprint is not removed, the "pharmaceutical elegance" of the product will be compromised due to the presence of flecks of dark material. Allow the tablets to air dry for a few minutes. Triturate the tablets to a coarse powder using a mortar and pestle. Transfer the powder into a 600-mL beaker then add about 340 mL of Sterile Water for Irrigation, USP and place on a magnetic stirrer. While stirring, add 16.8 g of sodium bicarbonate powder and stir for about 20 minutes until the tablet remnants have disintegrated and the coating has dissolved. While stirring, add another 16.8 g of sodium bicarbonate powder and stir for about 5 minutes until the powder dissolves. Add enough Sterile Water for Irrigation, USP, to bring the final volume to 400 mL and mix well. Transfer the suspension to an amber polyethylene terephthalate bottle with a child-resistant cap. Label the bottle "Shake Well Before Use," "Refrigerate" and "Protect from Light." Label with an expiration date of 62 days.