Evaluation of Empty Capsules for Norvir

Evaluation of Empty Capsules for Norvir

Disclaimer:

The following document describes a method for putting liquid ritonavir (Norvir) into capsules so that the capsules can be swallowed without experiencing the bad taste of the liquid preparation. Some patients have used this method to make the medication palatable. Although the method should work in theory, it has not been tested in patients. Specifically, no testing has been done to prove that the desired blood level of ritonavir is achieved with medication taken by this method. Persons who use or recommend this method must recognize that it is not approved by the Food and Drug Administration, nor is it validated by clinical studies.

P. Cohen, MD, PhD. Medical Editor, HIV InSite

by Harry Varav, Pharm.D.
HIV Care Manager / Chartwell Nations
Assistant Clinical Professor
UCSF School of Pharmacy
Division of Clinical Pharmacy

Due to the shortage of Norvir capsules, patients are being switched to the Norvir oral solution. Many patients are having difficulty tolerating the oral solution because of the strong smell and intolerable taste which is raising concerns about adherence to drug regimens. In an effort to increase tolerance of the Norvir oral solution, we evaluated the ability of empty capsules to contain the Norvir oral solution to minimize some of the difficulties associated with this formulation.

Products tested: Norvir oral solution 80mg/ml

Each product was filled with Norvir oral solution using a needless syringe and tested at room temperature. Each product was visually inspected for the time period specified and assessed for change in capsule shape and loss of ability to contain the solution. Each gelatin capsule was able to contain the Norvir oral solution without any visible loss of product. The vegetable capsule was unable to contain the Norvir oral solution for more than 10 minutes.

CAPSULE TYPETIME TO CHANGE IN CAPSULE SHAPETIME TO CAPSULE BREAKDOWN
Gelatin CapsSize “00”Solaray15 minutesAble to hold Norvir liquid for at least 7 days without capsule breakdown
Gelatin Caps #2J.R. Carlson Laboratories15 minutesAble to hold Norvir liquid for at least 72 hours without capsule breakdown
Gelatin Caps #1NOW Foods15 minutesAble to hold Norvir liquid for at least 72 hours without capsule breakdown
Vegetable VegicapsSize “0”Nature‚Äôs Way4 minutes10 minutes

 Average number of empty capsules required to contain 400mg of Norvir oral solution is six empty gelatin capsules (Size “00”). Actual number required for individual patient use may be higher or lower depending on an individual patients ability to fill the empty capsules. Any size capsule may be acceptable for use provided the correct dose is drawn into the syringe and transferred into the necessary number of empty capsules.Patient Instructions:1. Request 5ml syringe (without a needle) from your physician or pharmacist.2. Determine the amount of Norvir oral solution you need for your dose 5ml = 400mg 7.5ml = 600mg3. Use the 5ml syringe to withdraw the appropriate dose of Norvir oral solution and set aside in a clean area.4. Hold the larger area of the empty capsule in one hand and pull the top off with the other hand.5. Consider purchasing a “capsule holder” to make it easier to fill the capsules.6. Slowly fill the larger portion of the empty capsule with the Norvir oral solution until it is almost full.7. Put the top back on the larger portion of the empty capsule and place on a clean area.8. Repeat steps 4 through 7 until the entire syringe is empty.9. The capsules may change in shape and feel “soft” but do not be concerned. If there are no visible signs of Norvir oral solution on your “clean area”, then it is safe to proceed.10. Take your new Norvir oral solution “capsules” with food and swallow immediately to prevent any breakdown of the capsules by your saliva.

Addendum:

These capsules can be obtained from any health food store – I generally recommend Rainbow Foods on 13th/Folsom (in San Francisco). I’ve found that the Solaray product works the best – they come in different sizes – I recommend size 00. The “Vegicaps” can be used by patients who are vegetarians.


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