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Hospital compounding to face shortage: A case study of the development of a lopinavir-ritonavir oral suspension during the first wave of SARS-COV-2 in France.
Secretan, P-H; Thirion, O; Vieillard, V; Saunier, J; Razazi, K; Paul, M; Do, B.
  • Secretan PH; Paris Cardiovascular Research Centre, INSERM U970, Paris, France; Université Paris-Saclay, Matériaux et santé, 92296 Châtenay-Malabry, France. Electronic address: philippe-henri.secretan@universite-paris-saclay.fr.
  • Thirion O; Department of Pharmacy, Henri Mondor Hospital, AP-HP, Créteil, France.
  • Vieillard V; Department of Pharmacy, Henri Mondor Hospital, AP-HP, Créteil, France. Electronic address: victoire.vieillard@aphp.fr.
  • Saunier J; Université Paris-Saclay, Matériaux et santé, 92296 Châtenay-Malabry, France.
  • Razazi K; Service de Médecine Intensive Réanimation, Henri Mondor Hospital, AP-HP, Créteil, France; INSERM U955, Univ Paris Est Créteil, Créteil, France; CARMAS, Univ Paris Est Créteil, Créteil, France.
  • Paul M; Department of Pharmacy, Henri Mondor Hospital, AP-HP, Créteil, France; EpidermE, Univ Paris Est Creteil, 94010 Creteil, France.
  • Do B; Université Paris-Saclay, Matériaux et santé, 92296 Châtenay-Malabry, France; Department of Pharmacy, Henri Mondor Hospital, AP-HP, Créteil, France.
Ann Pharm Fr ; 80(3): 273-279, 2022 May.
Article in English | MEDLINE | ID: covidwho-1437555
ABSTRACT
The potential usefulness of lopinavir-ritonavir on Covid 19 infection during the first wave of contamination in France had boosted Kaletra® syrup prescription to the point of causing its national shortage. In the intensive care units of Parisian hospitals in charge of patients with life-threatening viral contamination, caregivers had to resort to lopinavir-ritonavir-based tablets, crushing them and then dispersing the powder in milk to facilitate administration by nasogastric tube. The difficulties and poor control of this degraded mode, which does not always ensure control of the amount of the drug in the prepared dose and may induce insufficient antiviral exposure, led us to develop in a very short time, while ensuring quality control proportional to the risk, a liquid form as an alternative to Kaletra® oral solution shortage. For this purpose, we describe this compounding formulation and its preparation process, while justifying the quality control strategy adapted to the risk as well as its chemical and physical stability. Based on the chemical and physical studies, the preparation was showed to be stable during at least 2 months between +2°C and +8°C and 1 week at room temperature. This has resulted in the design of kits that include multi-dose packaging and a measuring device and contain the appropriate quantities of drugs to ensure at least one week's treatment for each patient, during which time the kit in use can be stored at room temperature. The intensive care team used this treatment under conditions that they considered well adapted until the imported specialty became available.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ritonavir / COVID-19 Drug Treatment Type of study: Case report / Observational study / Prognostic study Limits: Humans Language: English Journal: Ann Pharm Fr Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ritonavir / COVID-19 Drug Treatment Type of study: Case report / Observational study / Prognostic study Limits: Humans Language: English Journal: Ann Pharm Fr Year: 2022 Document Type: Article