Formulation and evaluation of orodispersible tablet of taste masked doxylamine succinate using ion exchange resin

Abstract

Doxilamine orodispersible tablets were developed with considerable increase in drug release as compared to marketed formulations, seven formulations were developed and studied. The difference in drug release values was found to be 100.45 ± 1.89 and 56.47 ± 1.89, respectively. To prevent bitter taste and unacceptable odour of the drug, the drug was taste masked with weak cation exchange resins like Indion 234, Indion 204 and Indion 414. The drug was characterized according to different compendial methods, on the basis of identification by UV spectroscopy, pH, organoleptic properties and other tests. Among the three resins, one was selected for further studies i.e., Indion 234, because of high drug loading capacity. Drug-resin complex was prepared using batch method and effect of various processing parameters viz. drug-resin ratio, pH, temperature and drug concentration was studied to optimize the loading conditions. Maximum loading was obtained at drug-resin ratio 1:2, pH 5, temperature 50°C and drug concentration 4 mg/ml. A successful taste masking of resinate was confirmed by time intensity method and also by taking drug release in 0.01 N hydrochloric acid and in simulated salivary fluid. The values of pre-compression parameters evaluated, were within prescribed limits and indicated good free flowing properties. The data obtained of post-compression parameters such as weight variation, hardness, friability, wetting time, water absorption ratio, content uniformity, disintegration time and dissolution and was found superior over conventional formulation. The F5 batch with disintegration time 25.24 ± 0.75 and dissolution 100.46% ± 3.78 was selected as optimized formulation. This was compared with conventional marketed formulation and was found superior. Batch F5 was also subjected to stability studies for three months and was tested for its disintegration time, drug contents * Corresponding authors.

Mouth dissolving tablets- A unique dosage form curtailed for special purpose: a review

“…Hence, careful handling is required, along with that the tablets may leave unpleasant taste and/or grittiness in mouth if not formulated properly. In recent past many technologies have been developed to improve the formulation and purpose of MDTs with very interesting features, like extremely low disintegration time, exceptional taste masking ability, pleasant mouth feel and sugar free tablets for diabetic patients [3]. Each technology has a different mechanism and some of them will be reviewed later in this article, and each fast-dissolving / disintegrating dosage form varies regarding the following: * Mechanical strength of final product; * Drug and dosage form stability; * Mouth feel; * Taste; * Rate of dissolution of drug formulation in saliva; * Swallow ability; * Rate of absorption from the saliva solution; * Overall bioavailability.…”

“…MDTs are known by various names such as ast-melting, fast-dissolving, oral disintegrating or orodisperse The European Pharmacopoeia defines the term orodispersible tablet ""uncovered tablet for buccal cavity, where it disperses before ingestion"" [2,3]. Suitable drug candidates for such systems include neuroleptics, cardiovascular agents, analgesics, anti-allergics and drugs for erectile dysfunction [1,4].…”

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“…Tablet from each batch was individually weighed and wrapped in an aluminium foil and packed in black bottle and kept at above specified conditions in a heating humidity chamber for three months. After each month, tablet sample was analyzed for drug content, dissolution and disintegration time 8 .…”

Formulation and in vitro evaluation of fast dissolving tablets of metoprolol tartrate

“…On the basis of requests from patients to enhance their quality of life (QOL), new types of FDTs have been developed and then released globally by many pharmaceutical companies (Okuda et al, 2011). These tablets display a fast and spontaneous de-aggregation in the mouth, soon after coming into contact with saliva, dissolving the active ingredient and allowing absorption through all possible membranes it comes into contact with during deglutition (Puttewar et al, 2010).…”

“…The hardness is a function of physical properties of granules such as hardness and deformation under load, binders and above all the compressional force. The hardness has an influence on disintegration and dissolution times and is, as such, a factor that may affect bioavailabilities (Puttewar et al, 2010).…”