Physicochemical Characterization and Evaluation of the Binding Effect of Acacia etbaica Schweinf Gum in Granule and Tablet Formulations.

This study is aimed at evaluating the binding effect of Acacia etbaica gum in granule and tablet formulations using paracetamol as a model drug. Some physicochemical properties of the purified gum such as pH, the presence of tannin and dextrin, solubility, viscosity, loss on drying, total ash value, water solubility index, swelling power, moisture sorption, and powder flow properties were investigated. Paracetamol granules were prepared using wet granulation method at 2%, 4%, 6%, and 8% w/w of the Acacia etbaica gum and compared with granules prepared with reference binders (PVP K-30 and Acacia BP) in similar concentrations. The granules were characterized for bulk and tapped densities, compressibility index and Hausner ratio, angle of repose, flow rate, and friability. Finally, the prepared granules were compressed into tablets and evaluated for different tablet characteristics: weight uniformity, thickness, diameter, crushing strength, tensile strength, friability, disintegration time, and in vitro release profile. The physicochemical characterization revealed that tannins and dextrin are absent in the gum, and the gum has acidic pH. Both the moisture content and total ash values were within the official limits. Furthermore, the gum was found to be soluble in cold and hot water but insoluble in organic solvent and exhibited a shear thickening viscosity profile and excellent flow properties with excellent compressibility. The granules prepared with the gum of Acacia etbaica and reference binders showed good particle size distribution and excellent flow and compressibility properties. All the prepared tablets passed pharmacopeial specifications with respect to their uniformity of weight, thickness, and disintegration time. Tablets formulated with Acacia etbaica gum and acacia BP meet the compendial specification for friability at binder concentrations more than 2%. Drug release properties of all the batches formulated with Acacia etbaica, PVP, and acacia BP complied with the pharmacopeial specification. It can be concluded that the gum of Acacia etbaica could be explored as an alternative excipient for its binder effect in granule and tablet formulations.

Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations.

BACKGROUND: One of the major challenges in pediatric treatment is the lack of suitable drug preparations specifically designed and marketed for children. Most of the FDA approved drug formulations for adults have not been approved for use in pediatric patients. Shortage of suitable pediatric dosage information often leads health professionals to use adult formulations in an off-label manner. The aim of this work was to review the safety and biopharmaceutical challenges of commonly found excipients in off-label pediatric formulations as well as to show the current progress to alleviate pediatric toxicity related to excipients. METHODS: Research findings and medical case reports were searched from credible sources including Scopus, PubMed, OVID, Google Scholar, Embase, Cochrane Library, and Web of Science. RESULTS: As several studies and clinical case reports have revealed, off-label adult formulations usage causes pediatric patients to become exposed to potentially harmful excipients, which are essential components of drug products. In addition to their toxicities, some of the excipients affect the biopharmaceutical property of different drugs. Immature organ and body composition, large body surface area and slower metabolism and elimination capabilities of pediatrics are the main causes of toxicities associated with different excipients. Recent studies have also shown that good progress is being made to develop safe and suitable excipients for pediatric use. CONCLUSION: A risk and benefit assessment should be done before using off-label formulation as excipients cause mild to severe toxicities and biopharmaceutical problems to pediatric patients.

Evaluation of Grewia ferruginea Hochst ex A. Rich Mucilage as Suspending Agent in Metronidazole Benzoate Suspension.

Various species of the genus Grewia have been investigated for different pharmaceutical applications as excipients, yet a study on the potential use of Grewia ferruginea mucilage (GFM) as a suspending agent is lacking. Thus, this study is aimed at evaluating the efficacy of Grewia ferruginea mucilage (GFM) as a suspending agent in metronidazole benzoate suspension. The suspensions were prepared using 0.5%, 1%, 1.5%, and 2% w/v of GFM and compared with suspensions prepared from xanthan gum (XGM) and sodium carboxyl methyl cellulose (SCMC) in similar concentrations. The prepared suspensions were evaluated for visual appearance, pH, rheology, sedimentation volume, redispersibility, degree of flocculation, and in vitro drug release profile. Stability study was done at different storage conditions for three months. The results indicated that all the prepared suspension formulations exhibited pseudoplastic flow characteristics with viscosity imparting ability of the suspending agents in the order of XGM > GFM > SCMC (p < 0.05). The flow rate and redispersibility of the formulations prepared with GFM were significantly lower than those with SCMC and higher than those prepared with XGM. At 0.5% w/v suspending agent concentrations, the sedimentation volume of the formulations was in the order of XGM > GFM > SCMC (p < 0.05). However, at all other concentrations, the sedimentation volume of the formulations prepared with GFM had similar results with XGM but exhibited significantly higher sedimentation volume than SCMC. The formulations with GFM showed a higher degree of flocculation at 0.5% w/v concentration but were comparable at 1.5% w/v with XGM containing formulations. The pH, assay, and in vitro release profile of all assessed formulations were within the pharmacopial limit. Thus, based on the finding of this study, it can be concluded that Grewia ferruginea bark mucilage has the potential to be utilized as a suspending agent in suspension formulations.

Drug Use during Acute Illness in Tigray Region, Northern Ethiopia: A Household Study.

BACKGROUND: Drug use study in the community enables health authorities to understand pattern of drug utilization and its related aspects. This, in turn, can help to develop rational drug policies to be harmonized in accordance to the need of the community. OBJECTIVE: The aim of this study was to assess drug use during acute illness by the general population in Tigray region, Northern Ethiopia. METHOD: A community based cross-sectional study was undertaken in April 2013 in Tigray Region, Ethiopia. A total of 1034 households were interviewed in the study. A multi-stage sampling technique was used to select households. Data were collected using a pre-tested structured questionnaire. Data were analyzed using descriptive statistics and bivariate and multivariate logistic regression model. RESULTS: Out of 1000 households, 210(21%) reported an episode of acute illness. The prevalence of acute illnesses in rural areas 126(25%) (AOR = 1.83, 95% CI: 1.21-2.76) was significantly higher than that of urban areas 84(17%). Cough, runny nose, sore throat, earache, fever and headache added up to 155(52%) of all reported symptoms of acute illnesses. The majority of the patients 162 (77%) took modern medications for the managements of their diseases. Half 105(50%) of the consumed medications were antibiotics. The large proportions 173(83%) of medicines for acute illness were taken orally. The greater proportions 150(93%) of medications were prescribed by health professionals. Thirty-four households (21%) reported treatment discontinuation. CONCLUSION: The prevalence of acute illnesses in this study was found to be 21%. Acute illnesses were more common in rural areas than urban areas. Antibiotics were the most frequently used drugs for acute illnesses.