Carbidopa Capsules for Insulinoma Diagnostic: Compounding and Stability Study

Abstract

<jats:title>Abstract</jats:title><jats:sec id="j_pthp-2019-0013_s_007_w2aab3b7b6b1b6b1aab1c15b1Aa"><jats:title>Background</jats:title><jats:p>Carbidopa is a drug mainly used to treat Parkinson’s disease. Associations with levodopa or with levodopa/entacapone are commercialized, but there is no oral formulation of carbidopa alone available in Europe. As carbidopa can also be used as premedication of adult patients for insulinoma diagnosis, it must be compounded as single dose mg capsules. The single dose administration of a magistral preparation implies the compounding of only one capsule, or the loss of consequent quantities of active pharmaceutical ingredient. As an alternative solution, carbidopa capsules could be compounded as batches of hospital preparation.</jats:p></jats:sec><jats:sec id="j_pthp-2019-0013_s_008_w2aab3b7b6b1b6b1aab1c15b2Aa"><jats:title>Method</jats:title><jats:p>With this objective, a stability-indicating dosing method for 200 mg carbidopa capsules was developed. Then, the compounding process was assessed according to the European Pharmacopeia requirements. Finally, the stability of carbidopa capsules stored protected from light at room temperature was studied for one year.</jats:p></jats:sec><jats:sec id="j_pthp-2019-0013_s_009_w2aab3b7b6b1b6b1aab1c15b3Aa"><jats:title>Results</jats:title><jats:p>200 mg carbidopa capsules compounding process was validated on three independent batches. The beyond use date was fixed at one year.</jats:p></jats:sec><jats:sec id="j_pthp-2019-0013_s_010_w2aab3b7b6b1b6b1aab1c15b4Aa"><jats:title>Conclusion</jats:title><jats:p>Our work confirms that carbidopa 200 mg capsules can be realized in hospital pharmacy and its stability allows the compounding of large batches.</jats:p></jats:sec>

Paediatric capsule compounding in hospital practices: by weight or by volume?

“…Differences in pharmaceutical compounding reference sources between countries1 and compounding practices in Europe2 have been described. The manual preparation of capsules in Europe is often performed with a volume-based method,3–6 which involves weighing of the active pharmaceutical ingredient (API) and excipient added to the volume required to fill the capsules. In the USA a weight-based method prevails,7 8 and the volume required to fill the capsules must be converted to the mass of the excipient/API mixture.…”

“…The weight-based method is supposed to increase batch reproducibility as the weight of each component of the preparation remains the same between batches. However, even though several published papers have assumed the superiority of the weight-based method,5 9 to our knowledge, the differences between the two methods have never been studied. Therefore, in the present study qualified personnel made six batches of spironolactone 10 mg capsules with the weight-based method and six batches with the volume-based method, and the analytical differences between the two batches were studied.…”