New Orodispersible Mini Tablets of Enalapril Maleate by Direct Compression for Pediatric Patients

BACKGROUND:

In many countries, the hypertension in the pediatric population is considered an important risk of mortality and morbidity. In this sense, it is important to design and develop new pharmaceutical forms for pediatric patients with hypertension. The development of orodispersible mini-tablets (ODMTs) for paediatric use has gained importance within recent years the WHO authorities set up regulations for developing suitable and palatable dosage forms for paediatric patients.

OBJECTIVE:

The aim of this study was to design and develop orodispersible mini tablets of enalapril maleate for pediatric use.

METHODS:

Five pharmaceutical formulations were designed. The effects of different co-processed excipients and active pharmaceuthical ingredient at different doses were study. Lactose co-processed excipients selected were Tablettose® 80, MicroceLac® 100 and StarLac®. The micromeritic properties were evaluated for all the physical mixtures. The mini tablets were obtained by direct compression and quality control parameters were determined in accordance with United States Pharmacopeia.

Preparation, Characterization, and Evaluation of a Novel Co-Processed Excipient as a Directly Compressible Vehicle in Antihypertensive Tablet Formulation

Benefits of an Optimal Tabletability DC Mannitol on Compression Setting Parameters

Amorphous – state Characterization and Dissolution Behaviour of Efavirenz – Tocopheryl Polyethylene Glycol Succinate (TPGS)-1000 Solid Dispersions

RESULTS:

Three OMDTs with StarLac® provide good results of hardness, flowability and fast disintegration. One of them, with 0.1 mg of enalapril maleate, showed the best results for the official parameters of hardness (4.0 kp), friability (< 1%), disintegration time (28 s), drug content uniformity (103.6 %) and the best wetting time (23 s).

CONCLUSION:

The orodispersible mini tablets with StarLac® showed good officially quality parameters. One of them showed the best wetting time and doses for pediatric patients. This formulation could be considered eligible to be elaborated on an industrial scale.

See the article

Keywords: Enalapril maleate, orodispersible mini tablets, pediatric form, co-processed excipients, hypertension, direct compression.

Claudia A. Ortega, Laura S. Favier, Valeria A. Cianchino, Diego A. Cifuente
Current Drug Delivery
DOI : 10.2174/1567201817666200508093442

excipients formulation