Publication details
3D printed orordispersible films for benzodiazepine withdrawal treatement
| Authors | |
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| Year of publication | 2024 |
| Type | Conference abstract |
| MU Faculty or unit | |
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| Description | Benzodiazepines (BZDs) are among the most prescribed psychopharmaceuticals, often in unclear indications. Patients using BZDs on a long-term basis then become addicted without having relevant information about the potential for addiction. Attention should be paid to the withdrawal syndrome (AS) in the treatment of BZD dependence. This can occur after the first month of BZD abuse and increases in severity as the half-life of the drug shortens. For BZDs with a short biological half-life, the onset of AS can be observed after 24 hours of discontinuation. For BZDs with a long half-life, the onset of AS may be prolonged up to one week. The recommended approach for BZD dependence therapy is to switch the patient to an equivalent dose of a long-acting type of BZD (typically diazepam) and gradually reduce the dose by 10-25% per week (1). In terms of the start of therapy, diazepam is available on the market in two strengths (10 and 5 mg) as a splittable tablet, so that a dose of 2.5 mg can be comfortably achieved. Further dose reductions are hampered by the inability to obtain the exact dose by further splitting. Diazepam is also available as a single drug for individually prepared medicinal products (e.g. capsules). However, the pharmacy preparation of capsules containing such low doses of the drug is rather complex if the content uniformity of the drug is to be guaranteed (2). The ideal drug dosage form candidate for this application might be orodispersible films (ODFs). When prepared by 3D printing, the dose can be adjusted by the amount of drug in the printing material, as was proved by our previous studies, or by adjusting the number of printed layers (overall thickness) of the film, which would allow for more straightforward preparation due to the need to prepare only one stock mixture (3). In this work we aimed to prepare ODFs with dose ranging between 2.125 and 0.492 mg of diazepam in 10 levels (15% dose reduction between levels). Benzodiazepines (BZDs) are among the most prescribed psychopharmaceuticals, often in unclear indications. Patients using BZDs on a long-term basis then become addicted without having relevant information about the potential for addiction. Attention should be paid to the withdrawal syndrome (AS) in the treatment of BZD dependence. This can occur after the first month of BZD abuse and increases in severity as the half-life of the drug shortens. For BZDs with a short biological half-life, the onset of AS can be observed after 24 hours of discontinuation. For BZDs with a long half-life, the onset of AS may be prolonged up to one week. The recommended approach for BZD dependence therapy is to switch the patient to an equivalent dose of a long-acting type of BZD (typically diazepam) and gradually reduce the dose by 10-25% per week (1). In terms of the start of therapy, diazepam is available on the market in two strengths (10 and 5 mg) as a splittable tablet, so that a dose of 2.5 mg can be comfortably achieved. Further dose reductions are hampered by the inability to obtain the exact dose by further splitting. Diazepam is also available as a single drug for individually prepared medicinal products (e.g. capsules). However, the pharmacy preparation of capsules containing such low doses of the drug is rather complex if the content uniformity of the drug is to be guaranteed (2). The ideal drug dosage form candidate for this application might be orodispersible films (ODFs). When prepared by 3D printing, the dose can be adjusted by the amount of drug in the printing material, as was proved by our previous studies, or by adjusting the number of printed layers (overall thickness) of the film, which would allow for more straightforward preparation due to the need to prepare only one stock mixture (3). In this work we aimed to prepare ODFs with dose ranging between 2.125 and 0.492 mg of diazepam in 10 levels (15% dose reduction between levels). |