Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives

Orally disintegrating tablets (ODTs) rapidly disintegrate or dissolve in the oral cavity without using water. Demand for ODTs has increased, and the field has overgrown in the pharmaceutical industry and academia. It is reported that ODTs have several advantages over other conventional tablets. Since some of them are absorbed from the mouth, pharynx, and esophagus as the saliva passes down into the stomach, in such cases, the bioavailability of the drug improves meaningfully. Furthermore, the immediate release property of ODTs makes them a popular oral dosage form in patients with swallowing challenges, children, and for cases with a need for rapid onset of action. The current review article explains the features of active ingredients and excipients used in the formulation of ODTs, discusses multiple ODT formulation and preparation techniques with their merits and demerits, and also, offers remedies for problems associated with ODTs. Moreover, quality control steps and required considerations are presented.

Formulation and evaluation of oral disintegrating tablets of furosemide

Orally disintegrating tablets of Furosemide were prepared, evaluated and the comparison of the action of different concentrations of disintegrants on disintegration and dissolution of the tablets were studied. Direct compression method was used to prepare the orally disintegrating tablets containing 20 mg of Furosemide. The formulation was conducted using different concentrations of crospovidone, croscarmellose and sodium starch glycolate as superdisintegrants and their interactions with Furosemide were also evaluated using FTIR. FTIR studies using the drug and its mixtures with the excipients showed that the peaks correlate with one another which signify that there is no interaction between the drug molecule and the excipients used. The obtained results revealed that the disintegration time of ODTs were between 9 to 59 seconds. The percentage drug content of tablets in all the formulations was found between 91.51% to 106.69%, which complies with the limits established in pharmacopoeia. The in-vitro dissolution studies show maximum release of 89.47% in formulation F3 and minimum of 77.64% in formulation F12. Higher concentration of crospovidone and croscarmellose in formulations F3 and F6 showed better dissolution properties than SSG. So by varying the concentrations of superdisintegrants, oral disintegrating tablets can be formulated.

Natural Superdisintegrants for the Formulation of Orally Disintegrating Tablets

Oral route is the most favoured and preferred route for the administration for most of the dosage forms because it offers so many advantages over other routes of administration. Sometimes the oral route is associated with a problem called dysphagia. This condition can be seen in a population of paediatric, geriatric, patients with neurological problems, bedridden patients and so on. In order to overcome such a problem orodispersible tablets will be a better choice, because it will disintegrate within seconds when comes in contact with saliva. Natural agents offers so many advantages like nontoxic, easy availability, low cost, biocompatible and biodegradable in nature over synthetic agents. This superdisintegrants will cause the increase in drug release and decrease the disintegration time. This natural superdisintegrants will be a good option for the preparation of ODTs. Keywords: orodispersible tablets, natural superdisintegrants, advantages, dysphagia .

Formulation development and evaluation of Orally Disintegrating Tablets Rizatriptan Benzoate

Formulation research is oriented towards safety, efficacy and quick onset of action of existing drug molecule through novel concepts of drug delivery. Orally disintegrating tablets of Rizatriptan benzoate were prepared by direct compression method to provide faster relief from pain to migraine sufferers. About eleven formulations for the present study were carried out. Croscarmellose sodium, Crospovidone and Sodium starch glycolate (SSG) were used as superdisintegrants, while microcrystalline cellulose was used as diluent. The prepared batches of tablets were evaluated for weight variation, hardness, friability, wetting time, invitro dispersion time, drug content and invitro dissolution studies. The formulation containing combination of Croscarmellose sodium and Sodium starch glycolate showed rapid invitro dispersion time as compared to other formulations. The optimized formulation dispersed in 8 seconds. It also showed a higher water absorption ratio and 99.58% of drug is released within 2 minutes.

Computational Intelligence Model of Orally Disintegrating Tablets: An Attempt to Explain Disintegration Process

We obtained a curated database based on the database published elsewhere. Chemical descriptors were introduced as characteristics of active pharmaceutical ingredients (APIs). We used H2O AutoML platform in order to develop a Deep Learning model and SHAP method to explain its predictions. Obtained results were satisfactory with NRMSE of 8.1% and R2 of 0.84. Finally, we identified critical parameters affecting the process of disintegration of directly compressed ODTs.