Dosing Issues: Using Hot-drink Dosage Forms

The same dosage of a drug can be administered but can vary significantly in its rate of absorption, distribution, etc. A recent study demonstrated that an acetaminophen (APAP) hot-drink product was much more rapid acting than an APAP tablet.

The study (Pharm Res 2014; 31: 2078-2085) compared a hot-drink product (Beechams Flu Plus Hot Lemon Sachets) with standard APAP tablets (Panadol Original Tablets). The APAP dose was the same (1,000 mg) in both products but the Sachets also contained phenylephrine and ascorbic acid. The study involved 25 healthy male volunteers with no GI disorders that may impact the "normal" behavior of the formulations following administration. The Sachets were administered with 150 mL of hot water, and the tablets with 150 mL of room temperature water. Samples were collected at pre-dosing, then at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120, and 180 minutes post-dosing and analyzed.

The results following the hot drink showed APAP absorption was both significantly faster and greater over the first 60 minutes post-dose compared with the tablet; this is evidenced by the median time to reach a plasma APAP concentration of 0.25 mcg/mL, which was 4.6 and 23.1 minutes for the hot drink and tablet, respectively, with AUC_0-60 of 4,668 and 1331 h*ng/mL, respectively. Using pharmacoscintigraphy, the onset of gastric emptying after the hot drink was significantly faster than after the standard tablet (7.9 vs 54.2 minutes, respectively).

This study shows that a hot-drink formulation provides faster absorption of APAP potentially due to more rapid gastric emptying, along with factors such as a hot liquid dissolves the APAP more rapidly and the rate of dissolution is enhanced using the hot liquid. This may provide a counseling opportunity for pharmacists when discussing how to take selected medications where a rapid onset may or may not be desired; more study needs to be done to determine the significance with different medications.

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

Powdered Caffeine to be Banned?
U.S. Senator Sherrod Brown (D-OH) is urging the FDA to ban the sale and marketing of powdered caffeine. "A small amount of powdered caffeine can kill," said Brown; the FDA said one teaspoon of powdered caffeine is equal to 25 cups of coffee. Brown was joined by an Ohio couple who lost their son to a powdered caffeine overdose in May. The couple said they never knew Logan, an 18-year-old Keystone High School senior, took powdered caffeine. The substance can easily be bought online.
http://www.newsnet5.com/news/local-news/cleveland-metro/powdered-caffeine-is-responsible-for-at-least-one-death-and-kidney-failure-in-two-others-in-ohio

OSHA Cites New Haven Pharmacy for Chemical Spill
OSHA has cited a New Haven pharmacy for multiple violations during their most recent inspections following a July chemical spill that sent four employees to the hospital. The spill occurred on July 9th at the Walgreens location at 88 York Street; the spill took place in the pharmacy area where employees combined several chemicals that are used to treat cold symptoms, including phenol, eucalyptus, and liquid aspirin. Nearby workers got sick and four employees were taken to the hospital to be checked out; three were treated for inhalation exposure and one was treated for skin exposure at Yale-New Haven Hospital. All four were treated and released from the hospital the same day as the spill. The OSHA inspectors have been to the pharmacy twice since the spill and found that the pharmacy did not have an emergency action plan in place, and did not train their employees on how to handle emergencies, which is considered a major violation. OSHA's proposed fines total $77,220.
http://wtnh.com/2014/10/23/osha-cites-new-haven-pharmacy-for-multiple-violations/

Editor's Note: CompoundingToday.com has numerous applicable Standard Operating Procedures (SOPs) online and over the weekend will be adding additional SOPs that will specifically address the issue discussed above.

Proposal to Limit Pharmacies Dispensing Pain Meds for Medicare Drug Plans
The abuse of prescription pain relievers is a growing problem for Medicare drug plans. There is a limited ability to deal with this problem even if fraud is suspected. The drug plans are not allowed to restrict the availability of certain drugs—or restrict the drugstores that can supply benefits—to enrollees who abuse or resell them.

In August 2014, the Office of the Inspector General issued recommendations to reduce the questionable usage of narcotic pain relievers by Medicare beneficiaries. One of the recommendations was to establish a lock-in program, which would allow drug plans to restrict Medicare enrollees' ability to access drugs through multiple pharmacies or physicians. The "Protecting Integrity in Medicare Act of 2014" would give drug plans within Medicare Part D the authority to restrict certain beneficiaries to the use of a single doctor and pharmacy with respect to specific opioids and other high-risk drugs.
http://www.ncpa.org/pub/st359

Ibuprofen Better than Morphine for Kids with Fracture
Ibuprofen looks to be just as effective as morphine for pain control in children with uncomplicated fractures and has significantly fewer adverse effects, according to a study published online October 27 in the Canadian Medical Association Journal. In a parallel-group, randomized, blinded superiority trial involving 134 children treated for fracture in the emergency department of Children's Hospital in London, the authors recorded no significant difference in pain scores between the two drugs.
http://www.medscape.com/viewarticle/833895

Two Leukemia Drugs Question How Low is the FDA Drug Approval Bar
Cancer experts met to advise the FDA about ten years ago on whether to approve a new drug for rare types of leukemia and lymphoma in adults and children. The drug caused severe reactions in the brain and nervous system, and, in more than 75% of children, it did not produce the desired response. There was no proof that the drug, Arranon, kept children or adults alive any longer or that it improved their quality of life.

Despite the concern, the FDA approved Arranon in 2005; a drug which costs about $23,000 a month. It was approved based on a surrogate measure, contingent on a follow-up study to determine if it improved survival. However, nine years after its approval, that study by manufacturer GlaxoSmithKline is not complete and results are not expected until the end of 2016 (11 years after approval).
http://www.jsonline.com/watchdog/watchdogreports/two-leukemia-drugs-raise-question-of-how-low-fda-sets-the-approval-bar-b99371117z1-280438702.html

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Tip of the Week

Implement a program to address the issue of stability and beyond-use dates in your compounding pharmacy.

Looking Back

We don't know how,
To split an atom.
But as to whiskers,
Let us at 'em!
     Burma Shave

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

Glen Rock Medical Pharmacy, Glen Rock, New Jersey; Lorraine Carbognin, carbognin@verizon.net. Initial Accreditation for Sterile and Nonsterile Compounding

University Compounding Pharmacy, San Diego, California; Maria Orazi, maria@ucprx.com. Re-Accreditation for Sterile and Nonsterile Compounding

World Health Industries, Inc. DBA Rx Pro Pharmacy and Compounding, Jackson, Mississippi; LeAnn Chambers PharmD, leann@rxpro.net. Initial Accreditation for Nonsterile Compounding

The Wellness Center Pharmacy and Surgical, Old Bridge, New Jersey; Jeanne Lai, PharmD, jeanne@thewellnesscenterrx.com. Initial Accreditation for Nonsterile Compounding

Foothills Professional Pharmacy, Ltd., Phoenix, Arizona; Tim Vitullo, PharmD, tim@foothillspharmacy.com. Initial Accreditation for Nonsterile Compounding

True Custom Pharmacy, Austin, Texas; Laura Landrum, RPh, llandrum@truecustomrx.com. Re-Accreditation for Sterile and Nonsterile Compounding

AcaciaRx LLC DBA Acacia Apothecary and Wellness, Tucson, Arizona; Justin Brock, PharmD, justin@acaciarx.com. Initial Accreditation for Nonsterile Compounding