Abstract
Stencil printing is a commonly used printing method, but it has not previously been used for production of pharmaceuticals. The aim of this study was to explore whether stencil printing of drug containing polymer inks could be used to manufacture flexible dosage forms with acceptable mass and content uniformity. Formulation development was supported by physicochemical characterization of the inks and final dosage forms. The printing of haloperidol (HAL) discs was performed using a prototype stencil printer. Ink development comprised of investigations of ink rheology in combination with printability assessment. The results show that stencil printing can be used to manufacture HAL doses in the therapeutic treatment range for 6–17 year-old children. The therapeutic HAL dose was achieved for the discs consisting of 16% of hydroxypropyl methylcellulose (HPMC) and 1% of lactic acid (LA). The formulation pH remained above pH 4 and the results imply that the drug was amorphous. Linear dose escalation was achieved by an increase in aperture area of the print pattern, while keeping the stencil thickness fixed. Disintegration times of the orodispersible discs printed with 250 and 500 µm thick stencils were below 30 s. In conclusion, stencil printing shows potential as a manufacturing method of pharmaceuticals.
Highlights
Pharmaceuticals are predominantly produced according to a centralized and time-consuming batch processing approach [1]
The results show that stencil printing can be used to manufacture HAL doses in the therapeutic treatment range for 6–17 year-old children
The therapeutic HAL dose was achieved for the discs consisting of 16% of hydroxypropyl methylcellulose (HPMC) and 1% of lactic acid (LA)
Summary
Pharmaceuticals are predominantly produced according to a centralized and time-consuming batch processing approach [1] This supply chain model allows production of only a few dose strengths in large volumes, which for the blockbuster drugs are chosen based on population level information [2]. Challenges may arise if a patient is treated with an active pharmaceutical ingredient (API) with a narrow therapeutic window or a varying pharmacokinetic or pharmacodynamic profile. In these cases, patients would benefit from a more personalized dosing tailored according to the patient’s age, weight, body surface, gender, genetic profile, or treatment response [3,4]. Printing technologies have for instance shown to allow simultaneous personalized dose preparation and identification [5]
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