Neonatal and pediatric oral drug delivery: Hopes and hurdles.

The neonatal and pediatric populations have long been neglected concerning the development of oral dosage forms. For close to two decades, caregivers have had to adjust the doses of the off-label medicines and drugs for adults to suit the neonatal and pediatric needs. This is due to the lack of rules and regulations regarding neonates and pediatrics clinical trials while pharmaceutical industries see this as a non-lucrative approach. Despite such limitations, the administration of solid and liquid dosage forms to neonates and pediatrics necessitates the development of new technologies and even new strategies to meet the needs. Current approaches have not only focused on the development of suitable dosage forms but also the advancement of devices to enhance drug administration to pediatrics and neonates. Though current approaches have significantly added to the number of pediatric and neonatal oral dosage formulations on the market, there is still more room for improvement(s). While novel dosage forms including multiparticulates, orodispersible tablets/films, and chewable tablets have extensively been researched, some administration devices (e.g., nipple shield, pill swallowing cup, and solid dosage pen) have also been explored. Although a few of these products are in the market, the concerted efforts of regulation administrative bodies, pharmaceutical industry settings, and scientists in academia have been oriented to address all issues and advance the neonatal and pediatric-centric pharmaceutical products.

Development and evaluation of natural gum-based extended release matrix tablets of two model drugs of different water solubilities by direct compression.

The study was aimed at developing extended release matrix tablets of poorly water-soluble diclofenac sodium and highly water-soluble metformin hydrochloride by direct compression using cashew gum, xanthan gum and hydroxypropylmethylcellulose (HPMC) as release retardants. The suitability of light grade cashew gum as a direct compression excipient was studied using the SeDeM Diagram Expert System. Thirteen tablet formulations of diclofenac sodium (∼100 mg) and metformin hydrochloride (∼200 mg) were prepared with varying amounts of cashew gum, xanthan gum and HPMC by direct compression. The flow properties of blended powders and the uniformity of weight, crushing strength, friability, swelling index and drug content of compressed tablets were determined. In vitro drug release studies of the matrix tablets were conducted in phosphate buffer (diclofenac: pH 7.4; metformin: pH 6.8) and the kinetics of drug release was determined by fitting the release data to five kinetic models. Cashew gum was found to be suitable for direct compression, having a good compressibility index (ICG) value of 5.173. The diclofenac and metformin matrix tablets produced generally possessed fairly good physical properties. Tablet swelling and drug release in aqueous medium were dependent on the type and amount of release retarding polymer and the solubility of drug used. Extended release of diclofenac (∼24 h) and metformin (∼8-12 h) from the matrix tablets in aqueous medium was achieved using various blends of the polymers. Drug release from diclofenac tablets fitted zero order, first order or Higuchi model while release from metformin tablets followed Higuchi or Hixson-Crowell model. The mechanism of release of the two drugs was mostly through Fickian diffusion and anomalous non-Fickian diffusion. The study has demonstrated the potential of blended hydrophilic polymers in the design and optimization of extended release matrix tablets for soluble and poorly soluble drugs by direct compression.