ABSTRACT
Low amounts of minoxidil in oral dosage forms are commonly prescribed as anti-alopecic pharmacological treatments. Side effects are usually related to individual susceptibility. However, poor drug content and mass uniformity can lead to a potential risk of overdosing, and higher chances to experience side effects. The impacts of four formulation variables on drug content and mass pharmaceutical quality attributes were studied with an experimental design at two levels. The first variable (A) was the particle size of the direct compression microcrystalline cellulose (MCC) used as a diluent (Avicel® PH 101 vs. LP 200). The second variable (B) was the type of production process (direct filling vs. wet granulation). The third variable (C) was the particle size of riboflavin added as a color mixture indicator agent (granular vs. milled). The fourth variable (D) was the type of oral solid dosage form (capsule vs. tablet). In half of the formulations, the mean minoxidil content and minoxidil uniformity were out of the specification limits of the Pharmacopoeia, demonstrating the importance of carefully selecting the excipients as well as the utilized process when manufacturing low oral dosage minoxidil formulations. The best minoxidil content uniformity was achieved when using MCC LP 200, wet granulation, granular riboflavin, and capsules. However, tablets are the recommended dosage form when utilizing Avicel® PH 101 or direct filling. Meeting these criteria, the content and mass uniformity are more likely to meet the specification limits of the Pharmacopeia. Techniques such as NIR spectroscopy should be implemented to control the quality of extemporaneous compounding formulations with a low dose of active ingredient.
ABSTRACT
BACKGROUND: Vertigo is a common medical condition with a broad spectrum of diagnoses which requires an integrated approach to patients through a structured clinical interview and physical examination. The main cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV), which should be confirmed by a positive D-H positional test and treated with repositioning maneuvers. The objective of this study is to evaluate the effectiveness of Epley's maneuver performed by general practitioners (GPs) in the treatment of BPPV. METHODS/DESIGN: This study is a randomized clinical trial conducted in the primary care setting. The study's scope will include two urban primary care centers which provide care for approximately 49,400 patients. All patients attending these two primary care centers, who are newly diagnosed with benign paroxysmal positional vertigo, will be invited to participate in the study and will be randomly assigned either to the treatment group (Epley's maneuver) or to the control group (a sham maneuver). Both groups will receive betahistine. Outcome variables will be: response to the D-H test, patients' report on presence or absence of vertigo during the previous week (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert-type scale in the previous week, total score on the Dizziness Handicap Inventory (DHI) and quantity of betahistine taken. DISCUSSION: Positive results from our study will highlight that treatment of benign paroxysmal positional vertigo can be performed by trained general practitioners (GPs) and, therefore, its widespread practice may contribute to improve the quality of life of BPPV patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01969513.
Subject(s)
Benign Paroxysmal Positional Vertigo/therapy , Physical Therapy Modalities , Primary Health Care/methods , Benign Paroxysmal Positional Vertigo/diagnosis , Benign Paroxysmal Positional Vertigo/physiopathology , Betahistine/therapeutic use , Clinical Protocols , General Practitioners , Histamine Agonists/pharmacology , Humans , Research Design , Spain , Time Factors , Treatment Outcome , Urban Health ServicesABSTRACT
Non-induced hypothermia is caused by anesthetic techniques, surgical procedures, and the environmental temperature in operating rooms, which affect the body's physiologic thermoregulation mechanisms. Postoperative hypothermia occurs in 93% of surgical patients and is accompanied by shivering in 65% of cases. Non-induced hypothermia affects the patient's postoperative recovery, as it alters metabolic response and reduces the patient's comfort during this period. Within the protocol for controlling postoperative hypothermia, the main objective of the nurses' aide consists of detecting and recording postoperative hypothermia, as well as of correcting the deficit by means of active warming of the body's external surface. These activities not only aid the patient's recovery and reduce complications, but also lower healthcare costs and increase postoperative comfort.
Subject(s)
Hypothermia/nursing , Nursing Assistants , Postoperative Care/nursing , HumansABSTRACT
La hipotermia no inducida está producida por las técnicas anestésicas, los procedimientos quirúrgicos y la temperatura ambiente de los quirófanos que alteran los mecanismos de la termorregulación fisiológica del organismo. La hipotermia posquirúrgica se presenta en un 93% de los pacientes quirúrgicos y en un 65% aparece acompañada de escalofríos. La hipotermia no inducida repercute en la recuperación del paciente posquirúrgico, ya que altera su respuesta metabólica y disminuye su grado de confort durante este período. El objetivo principal del auxiliar de enfermería, dentro del protocolo de actuación de control de la hipotermia posquirúrgica, consiste en detectar y registrar las situaciones de hipotermia postoperatoria, así como corregir el déficit mediante el calentamiento activo externo de la superficie corporal. Estas actividades no sólo repercuten en la recuperación del paciente y en la disminución de complicaciones, sino también en la disminución del gasto sanitario y el aumento del confort postoperatorio(AU)
Non-induced hypothermia is caused by anesthetic techniques, surgical procedures, and the environmental temperature in operating rooms, which affect the body's physiologic thermoregulation mechanisms. Postoperative hypothermia occurs in 93% of surgical patients and is accompanied by shivering in 65% of cases. Non-induced hypothermia affects the patient's postoperative recovery, as it alters metabolic response and reduces the patient's comfort during this period. Within the protocol for controlling postoperative hypothermia, the main objective of the nurses aide consists of detecting and recording postoperative hypothermia, as well as of correcting the deficit by means of active warming of the body's external surface. These activities not only aid the patient's recovery and reduce complications, but also lower healthcare costs and increase postoperative comfort(AU)
