Pediatric galenic adaptation, when compassionate use is not enough: the case of Clindamycin

4 October 2023

M. Jacquet, R. Mazet, J. Arata-Bardet, M. Durand, S. Chanoine, M.-D. Brunet, P. Bedouch
Centre Hospitalier Universitaire Grenoble-Alpes, France

Background and Objectives
We present the case of a 6-year-old child (26.3 kg) suffering from methicillin-sensitive S. aureus osteomyelitis following an open phalangeal fracture. This patient received intraveinous cloxacillin for 5 days followed by oral cotrimoxazole and rifampicin bitherapy. 15 days after treatment initiation, in view of cotrimoxazole-induced cutaneous toxicity and neutropenia, cotrimoxazole was replaced by clindamycin. Commercial forms (capsules) and compassionate use (oral suspension) exist but are unfortunately not suitable for this patient: capsule sizes too large to be swallowed and poor palatability even when taken with food [1]. The objective of this work was to find a suitable solution for this patient to ensure treatment adherence and efficacy.

Material and Methods
First, we tried to mask the bitterness using 8 types of food described in literature for their clindamycin-masking properties. For each type of food, palatability was assessed on 3 persons according to 4 criteria (average out of 10): taste (out of 5), aftertaste (out of 5), odor (out of 2) and texture (out of 2). As a second step, we considered the preparation of custom-made capsules for this patient. 2 empty capsule sizes (4 and 5) were given to the parents to assess the largest swallowable capsule size. An abacus of the maximum quantity of clindamycin for each capsule size was constructed.

The best masking results were obtained with chocolate cream dessert (6.7/10) and white chocolate (6.7/10). To obtain the best results, white chocolate had to be taken before and after the chocolate cream dessert to line the mouth [2]. Since, palatability remained relatively poor and the process complex, we tried the second option by preparing custom-made capsules. The patient was able to swallow size 4 capsules containing 105mg of clindamycin, which represented 5 capsules twice a day. After 6 weeks of trouble-free treatment, recovery was considered complete from clinical, biological and radiographic points of view.

Discussion - Conclusion
Although commercial forms exist, their poor palatability is a hurdle for adherence to treatment, especially in the pediatric population. The development of adapted pharmaceutical forms to mask taste is essential to ensure treatment efficacy. Pediatricians at our facility now have empty capsules of different sizes at their disposal, to be able to prescribe the appropriate capsules straight away in this type of situation. However, the issue remains for children unable to swallow capsules.

[1] Gee SC, Hagemann TM. Palatability of liquid anti-infectives: clinician and student perceptions and practice outcomes. J Pediatr Pharmacol Ther. 2007;12(4):216-223. doi:10.5863/1551-6776-12.4.216
[2] Truong S, Tang EKY, Khan RN, et al. Prior administration of chocolate improves the palatability of bitter drugs: The Choc-with-Med study. J Paediatr Child Health. 2021;57(8):1267-1273. doi:10.1111/jpc.15448

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