Compounding With Organic Salts

Question:
Prescription #1 calls for 10 mL of fentanyl 50 mcg/ 0.1 mL (as the citrate) topical gel. Fentanyl preparations are dosed on the amount of fentanyl (C₂₂H₂₈N₂O), present as the citrate. So, how much fentanyl citrate will be required?

Answer:

1. 50 mcg/0.1 mL = X mcg/10 mL            X = 5 mg
2. Fentanyl MW = 336.47
   Fentanyl citrate MW = 528.59
3. 336.47/5 mg = 528.59/X            X = 7.85 mg
4. Each mg of fentanyl equals 528.59/336.47 = 1.57 mg fentanyl citrate

Question:
Prescription #2 calls for 30 capsules of Diphenhydramine hydrochloride 35 mg each. Diphenhydramine Hydrochloride Capsules USP are based on the total molecule (i.e., diphenhydramine hydrochloride). The United States Pharmacopeia (USP) states "Diphenhydramine Hydrochloride Capsules USP contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of diphenhydramine hydrochloride (C₁₇H₂₁NO.HCl)." As one can see, the weight of the "HCl" is considered in the dose of the drug. How much diphenhydramine hydrochloride will be required?

Answer:
Since the total salt molecule is part of the dose, 30 � 35 mg = 1.05 g of diphenhydramine hydrochloride is required.

It is important to know what form of a drug is used for "dosing." Many drugs are "salts" and the dose may be based on the total salt form or just the base form of the drug. The purity and form of all ingredients used in compounding, especially of active pharmaceutical ingredients (APIs) must be known and considered during formulation. If not considered, the final compounded preparation may not fall within the strength requirements (e.g., 90% to 110% for compounded preparations or the USP monograph's specifications, and the patient may be seriously over or under dosed.

This has always been a problem because there has never been a standard method of naming drug dosage forms, base or salt; both the official USP-National Formulary monographs and the FDA-approved drug products appear to be inconsistent in how they determine how a drug is dosed.

It is the responsibility of the compounding pharmacist to determine whether or not the base/acid of salt form of the drug is to be used in the calculations for the amount of API to actually be used. To determine the "form" of the drug (base or salt), one can use the USP or the product package insert, or one can contact the manufacturer or physician as appropriate.

For further information, see IJPC XIV (4), July/Aug 2010: 322-326.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Ten "In-process" Drugs that Could Stop Ebola

Source: FierceBiotech Research

South Jersey Pharmacist Admits to Bribing Physicians
A South Jersey pharmacist has admitted paying tens of thousands of dollars in cash bribes to physicians for referring pain cream prescriptions. Vladimir Kleyman, a 43-year-old Lakewood resident who was the president and pharmacist-in-charge of Prescriptions R US, pleaded guilty to conspiracy to pay kickbacks and commit healthcare fraud. He faces up to five years in prison when he's sentenced January 20.

Kleyman admitted that during November and December 2013 alone, he arranged for a middleman to receive more than $40,000 in cash or checks with the understanding it would be used to pay bribes. He also admitted he knew that certain health-insurance carriers did not cover compounded pain cream but dispensed the pain cream and obtained payment from their insurance carriers by falsely representing the pain cream to be other covered items.
http://www.nbcphiladelphia.com/news/local/New-Jersey-Pharmacist-Bribes-Physicians-279169041.html?partner=nbcnews

AstraZeneca Paid $465K to Two Texas State Mental Health Officials
The Texas Attorney General has filed a state lawsuit accusing AstraZeneca of illegally marketing its antipsychotic Seroquel for unapproved uses and paying kickbacks to physicians and state health officials. This action builds on whistleblower suits filed by two former AZN sales representatives. The company allegedly paid $465K to two unidentified state mental health officials "for speaking engagements" who had the power to influence the formulary decisions with the state hospital system. AZN settled a Justice Department suit in 2010 regarding its marketing of Seroquel for $520M. The Texas AG sued J &J's Janssen unit over alleged illegal marketing of its antipsychotic Risperdal two years ago by paying $181M.
http://seekingalpha.com/news/2025605-texas-takes-exception-to-astrazenecas-marketing-of-antipsychotic

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Did You Know ...

�that oftentimes "opinions" seem to take the place of "facts" in much of what occurs today, both politically and professionally?

Tip of the Week

Base your actions on "facts" and not "opinions"; opinions change and often go by the wayside and are like the wind, frequently changing; facts, however, form a better foundation for one's actions.

Looking Back

Regardless of
Political views,
All good parties,
Always Choose
     Burma Shave

ACHC is pleased to announce that the following pharmacies have achieved PCAB Accreditation:

The Remedy Pharmacy, Torrance, California; Nilesh Bhakta, PharmD, nilesh@theremedypharm.com. Re-Accreditation for Nonsterile Compounding

The Apothecary Shoppe, Tulsa, Oklahoma; D.J. Lees, PharmD, djlees@apothecarytulsa.com. Initial Accreditation for Sterile & Nonsterile Compounding

Knowles Apothecary, Kensington, Maryland; Alan Chiet, RPh, alanc@knowleswellness.com. Initial Accreditation for Sterile & Nonsterile Compounding

Keystone Pharmacy, Grand Rapids, Michigan; David Miller, RPh, PhD, dmiller49301@comcast.net. Re-Accreditation for Sterile & Nonsterile Compounding

California Pharmacy & Compounding Center, Newport Beach, California; Glen Olsheim, glen@ca-rx.com. Re-Accreditation for Sterile & Nonsterile Compounding

Central Avenue Pharmacy, Pacific Grove, California; Dana Gordon, PharmD, dana@caprx.com. Re-Accreditation for Nonsterile Compounding

La Vita Compounding Pharmacy, San Diego, California; Christine Givant, RPh, Chris@LaVitaRx.com. Re-Accreditation for Sterile & Nonsterile Compounding

Eastern States Compounding Pharmacy, Littleton, New Hampshire; David Rochefort, RPh, david@easternstatesrx.com. Re-Accreditation for Sterile & Nonsterile Compounding

Foundation Care, Earth City, Missouri; Brooke Knaust, Regulatory@foundcare.com. Re-Accreditation for Sterile & Nonsterile Compounding

The Pill Box Pharmacy, Decatur, Alabama; Catherine Henderson, PharmD, thepillboxofdecatur@gmail.com. Initial Accreditation for Sterile & Nonsterile Compounding

Reed's Compounding Pharmacy, Tucson, Arizona; Dana Reed-Kane, PharmD, dana@reedsrx.com. Re-Accreditation for Sterile & Nonsterile Compounding

Apothecary by Design Compounding, Portland, Maine; Cassi Brooks, cbrooks@apothecarybydesign.com. Initial Accreditation for Nonsterile Compounding

Medical Center Pharmacy, Wilmington, North Carolina; Amanda Loeffel, amanda.loeffel@mcpnc.com. Re-Accreditation for Sterile & Nonsterile Compounding

Central Rexall Drugs, Hammond, Louisiana; John Mark Rolling, PharmD, johnmark@centraldrugs.net. Initial Accreditation for Sterile & Nonsterile Compounding

Inverness Lone Star Pharmacy, LLC, Murphy, Texas; Michael Sands, S1SANDS@yahoo.com. Initial Accreditation for Nonsterile Compounding