| Recurrent aphthous ulcer is a disease that often occurs in the oral mucosa of the human body and the lesion surface is actively individualized.The incidence rate is extremely high,and the susceptible population is gender,age and race.The pathogenesis of recurrent aphthous ulcer is still unclear.It is characterized by a round or round-like gray-white pseudo-membrane erythema with a radius of 3-5 mm at the oral mucosa,and persistent inflammation and pain;due to the particularity of the diseased part Traditional pharmaceutical dosage forms do not treat the disease well,causing it to seriously interfere with the normal life of the patient.Dexamethasone acetate is a representative drug in the first-line treatment of recurrent aphthous ulcers.It has a powerful anti-inflammatory effect and slows down pain edema by inhibiting the synthesis of prostaglandins,which can effectively slow the recurrence of aphthous.The pain caused by ulcers is less,and the side effects are less and controllable.The dexamethasone acetate oral paste on the market now has problems such as low adhesion,slow drug release rate,strong foreign body sensation in the oral cavity,and inability to achieve individualized administration of the patch administration area,which greatly reduces the problem.Drug treatment effects and patient medication compliance.Therefore,oral dexamethasone acetate patch is urgently needed and designed to be a patch with strong adhesion,fast drug release rate and individualized administration.The layer-by-layer preparation technique is to construct a designed 3D model by depositing or bonding materials in a continuous layer,to achieve precise control of the spatial distribution of active pharmaceutical ingredients(API)in the dosage form,to generate complex geometries,and to deposit a very small amount of API.Reduce waste and allow rapid preparation of different compositions to screen for drug activity and to prepare individualized strength.In this research,the dexamethasone acetate oral patch was prepared by layer-by-layer preparation technique and individualized research was carried out.Firstly,the tablet's appearance,in vitro adhesion,in vitro adhesion time,and cumulative release at 3 hours were used as indicators.The filler was selected as corn starch,the adhesive was hydroxypropyl methylcellulose(HPMC E50),and the penetration enhancer was used.Polyethylene glycol(PEG 6000),binder is povidone,ethanol concentration is 60%,75%,90%,followed by single factor screening and orthogonal test optimization prescription,the best prescription is:corn starch 74.14%,HPMC E5020%,PEG 6000 is 5%,ethanol concentration is 75%,binder is povidone(PVP K30),and the optimum individualized tablet process parameters are:tablet radius 3mm,4mm,5mm The sheet thicknesses are 1.6mm,1.0mm,0.6mm,the layer height is 0.31mm,and the number of layers is 5,3,and 2 layers respectively.Then,the quality evaluation of these three radius oral patches is evaluated.Indicators include tablet hardness,in vitro adhesion,in vitro adhesion time,dissolution,content determination,content uniformity,tablet appearance,microstructure,differential scanning calorimetry,infrared absorption spectroscopy,friability,weight difference,results Show that all three tablets are of acceptable quality;Release of the study;the study of the stability of the final tablets behavior,including stress testing,accelerated testing and long-term stability tests have indicated three different radii tablet quality.In this experiment,the dexamethasone acetate oral patch with different radii was prepared by layer-by-layer preparation technique.By comparing the traditional tableting technology,the operation was faster,the tablet quality was more perfect,and the properties were stable.This article takes a new perspective to understand the concept of individualized drug delivery in 3D drug printing,and provides new ideas for establishing new therapeutic concepts and intelligently addressing individualized drug delivery protocols and approaches. |
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