Melt-processed polymeric cellular dosage form
A cell-like, dosage-form technology, applied in the direction of pill delivery, bulk delivery, organic active ingredients, etc., can solve the problems of low drug release rate, only suitable for long-term release or sustained release, not suitable for immediate drug release, etc.
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example 1
[0175] Example 1: Preparation of Cellular Dosage Forms
[0176] This example demonstrates exemplary fabrication of cellular dosage forms. Acetaminophen and polyethylene glycol 8000 were chosen as active ingredients and excipients for this example.
[0177] Preparation of cellular dosage forms:
[0178] The acetaminophen powder was first screened using a stainless steel mesh (size No. 270) with a nominal opening of 53 μm. The drug particles were then combined with solid polyethylene glycol 8000 (PEG 8000) flakes to obtain a formulation of 63% acetaminophen and 37% PEG 8000 by weight. Then, the mixture was heated to 90° C. and kneaded until a homogeneous paste was formed. Subsequently, aliquots of the paste were placed in stainless steel molds maintained at 25°C. The aliquot was compressed and cooled to obtain a casting pan with a diameter of 13 mm and a thickness of 2.5 mm. This disc was used as a reference for the unfoamed sample. For the preparation of cell-like dosag...
example 2
[0180] Example 2: Images and Characterization of Microstructures
[0181] This example demonstrates exemplary characterization of the microstructure in cellular dosage forms using scanning electron microscope images.
[0182] Scanning Electron Microscope (SEM):
[0183] A cross-section of the dosage form showing its microstructure for SEM imaging was obtained by first scoring the sample with a razor blade and then fracturing it along the score. A Zeiss Merlin high resolution SEM with GEMINI column was used to acquire images. Imaging is performed with a lensed secondary electron detector. An accelerating voltage of 5 kV and a probing current of 95 pA were applied.
[0184] Referring to Figure 1, this shows the morphology of the structure which can be customized by adjusting the process conditions. High T s and p s Increased void volume fraction and open cell fraction. τ r Only minimally affects the void volume fraction, but has a dramatic effect on the diameter of the...
example 3
[0196] Example 3A: Lysis of Cellular Dosage Forms
[0197] This example demonstrates an exemplary dissolution test of a cellular dosage form showing that the dosage form is suitable for immediate drug release.
[0198] Dissolution test:
[0199]The dosage form is first attached to the annular disc. Then, the sample was placed at the bottom of a dissolution vessel (in Sotax dissolution bath) filled with 900 ml of 0.05 M phosphate buffer solution (using sodium dihydrogen phosphate and dihydrogen phosphate) at pH 5.8 and temperature 37°C sodium). The solution was stirred with a paddle rotating at 50 rpm. The concentration of dissolved drug was measured by UV absorbance at 244 nm using a fiber optic probe (Pion) with a path length of 2 mm.
[0200] Dissolving time t 0.8 OK for:
[0201] The time to dissolve 80% of the drug content was determined from a curve showing the amount of drug dissolved versus time.
[0202] Snapshots of dissolved closed-cell and open-cell dosage fo...
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Abstract
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