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Individual Oral Therapy with Immediate Release and Effervescent Formulations Delivered by the Solid Dosage Pen
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf 40225, Germany
* Author to whom correspondence should be addressed.
Received: 18 September 2012; in revised form: 17 October 2012 / Accepted: 29 October 2012 / Published: 6 November 2012
Abstract: New devices enabling freely selectable dosing of solid oral medications are urgently needed for personalized medicine. One approach is the use of the recently published Solid Dosage Pen, allowing flexible dosing of tablet-like sustained release slices from drug loaded extruded strands. Slices were suitable for oral single dosed application. The aim of the present study was the development of immediate release dosage forms for applications of the device, especially for young children. Using two model drugs, two different concepts were investigated and evaluated. Effervescent formulations were manufactured by an organic wet-extrusion process and immediate release formulations by a melt-extrusion process. Dissolution experiments were performed for both formulations to ensure the immediate release behavior. Extruded strands were individually dosed by the Solid Dosage Pen. Various doses of the two formulations were analyzed regarding uniformity of mass and content according to pharmacopoeial specifications. Proof of concept was demonstrated in both approaches as results comply with the regulatory requirements. Furthermore, storing stress tests were performed and drug formulations were characterized after storing. The results show that suitable packaging material has been selected and storage stability is probable.
Keywords: personalized medicine; individual therapy; delivery device; extrusion; pediatrics; geriatrics
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Wening, K.; Laukamp, E.J.; Thommes, M.; Breitkreutz, J. Individual Oral Therapy with Immediate Release and Effervescent Formulations Delivered by the Solid Dosage Pen. J. Pers. Med. 2012, 2, 217-231.
Wening K, Laukamp EJ, Thommes M, Breitkreutz J. Individual Oral Therapy with Immediate Release and Effervescent Formulations Delivered by the Solid Dosage Pen. Journal of Personalized Medicine. 2012; 2(4):217-231.
Wening, Klaus; Laukamp, Eva J.; Thommes, Markus; Breitkreutz, Jörg. 2012. "Individual Oral Therapy with Immediate Release and Effervescent Formulations Delivered by the Solid Dosage Pen." J. Pers. Med. 2, no. 4: 217-231.