Formulation and In Vitro Evaluation of Taste- Masked Prednisolone Orodispersible Tablets

Abstract

Background: Prednisolone is a corticosteroid with a very bitter taste acts as anti- anti-inflammatory and immune suppressant drug and it is used at any age.

Objective: To improve patient compliance by masking the bitter taste of the drug to be delivered as an orodispersible tablet.

Methods: External ionic gelation using sodium alginate (0.5%w/v) and calcium chloride (1% w/v) in presence of 0.5% w/v carbopol 940 was used to prepare taste masked beads loaded with prednisolone to be compressed as orodispersible tablets.

Results: The bitter taste of was masked by preparing beads composed of 1:1:1 (sodium alginate: Carbopol 940: prednisolone) which released only 0.77 % of the drug in pH 6.8 (pH of oral cavity).

The ODT prepared by direct compression using taste masked beads equivalent to 5 mg PRD, 3% crospovidone, 2% PVP, 1% talc, 1% magnesium stearate and combination of Avcil® PH 102 and mannitol at (1:1) ratio was the optimum formula  (T6) with hardness of 3.9± 0.32 kg, , friability 0.45%, thickness 2.5 ± 0.05 mm, % drug content  98.2% ± 1.8, wetting time 18.7 ± 1.3 sec, water absorption 41 ± 2.1%, disintegration time 15.3 ± 0.5 sec. and released only 0.75% ± 0.01 of PRD in an oral pH of 6.8 within one minute (indicating good taste masking). Its release in the stomach (pH 0.1N HCl) and intestine (pH 6.8) was continued for up to two hours.   

Conclusion: It can be concluded that the external ionic gelation method successfully masked the bitter taste of prednisolone and can also be formulated as taste-masked orodispersible tablets by the direct compression method.

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Beads preparation

The preparation of PRD-beads as ODT Taste-masked ODT of PRD  was prepared by direct compression and wet granulation methods using crospovidone as super-disintegrant, mannitol and Avicel® PH 102  as  diluents, talc as a glidant and magnesium stearate as a lubricant as shown in Table (1). The beads-powderblend  was  evaluated  for  its flow  properties  before  compression. After  that,  the blend with accepted flow properties was compressed into tablets.

JFac. Med Baghdad 2023; Vol.65, No.3, Received: Jan. 2023, Accepted: May 2023, Published: Oct.2023, Formulation and In Vitro Evaluation of Taste-Masked Prednisolone Orodispersible Tablets,  Hiba M.Suzi, Eman B. H. Al-Khedairy, Doi:https://doi.org/10.32007/jfacmedbagdad.2057

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