Formulation and Evaluation of Orally Disintegrating Films of Levocetirizine Dihydrochloride

Abstract

The present investigation was undertaken with the objective of formulating taste-masked orally-disintegrating films of the bitter levocetirizine dihydrochloride to enhance the convenience and compliance by the elderly or paediatric or bedridden and non-cooperative patients due to its ease of administration. Scope of this study was to explore the film forming properties of various film formers like modified starch, pullulan, hydroxypropyl methylcellulose and polyvinyl alcohol-polyethylene glycol based polymers. Plasticizers like glycerin, propylene glycol, sorbitol and polyethylene glycol 400 were evaluated by studying their effect on folding endurance, peelablity and in vitro disintegration time. Films were prepared by solvent casting method. Drug-loaded films, which composed of the selected polymers with the suitable plasticizer showed excellent film forming capacity along with good folding endurance, in vitro disintegration time within 22 s and >95% drug release in 10 min as compared to marketed immediate release tablets, which showed on 30.4% at the end of 10 min The films prepared were 30-40 mg in weight with pleasant taste with bitter active being successfully taste masked by a mixture of sucralose and monoammonium glycerrhizinate producing an extended sweetness profile. Furthermore, the orally disintegrating films were stable for at least 3 mon when stored at 40° and 75% relative humidity. The formulation developed is simple, easy to prepare and economical with great applicability during the emergency cases such as allergic reactions, whenever immediate onset of action is desired.

Role of freeze drying technology in the development of orally disintegrating films

“…Samples of drug dissolved are collected at pre-determined intervals and are analyzed by using UV-spectrophotometer. Despite of its extensive use, dissolution test is still prone to noteworthy in accuracy and tests let down ( Chaurasiya et al, Irfan et al, 2015;Kathpalia and Patil, 2017).…”

“…The Weight variation test of a film is calculated in triplicate by cutting the film and determining weight of each film. Uniformity in thickness is important to ascertain as it is directly proportional to dose accuracy of the film (Chaurasiya et al, 2016;Kathpalia and Patil, 2017; ). Irfan et al, 2015 Dryness test/Tack test This test is performed to find out the ability of a film to get adhered to a piece of paper pressed between strips.…”

“…According to USP27, the contents should range from 85-115% with the standard deviation of less than or equal to 6%. The content uniformity test is performed to estimating drug contents in individual film (Patel et al, 2016;Chaurasiya et al, 2016;Kathpalia and Patil, 2017).…”

Formulation and Evaluation of Fast Dissolving Film of Lornoxicam

“…Content uniformity is determined by estimating the active ingredient contained in each film. Limit of content uniformity is 85-115% with a SD which must be ≤6% [22]. From Table 3, it can be seen that the levels of drug in the film range between 95% and 112%.…”

Fast Dissolving Oral Films: A Tabular Update

“…The prepared films of Palonosetron were evaluated for parameters like thickness uniformity, weight uniformity, folding endurance, percentage moisture loss, tensile strength, percentage elongation, drug content uniformity, in-vitro disintegration time, invitro dissolution studies 43 Orally disintegrating films of Tramadol Hydrochloride were prepared which disintegrate within 30 seconds. Two polymers such as modified pea starch (Lycoat RS 720) and pullulan were evaluated for film forming capacity and were found to form thin, smooth films at 25% w/w and 2% w/w concentration respectively 48 .…”