Chronic pelvic pain syndrome: Highlighting medicinal plants toward biomolecules discovery for upcoming drugs formulation.

Chronic pelvic pain syndrome (CPPS) can be triggered by a various types of gynecological, gastrointestinal, urological, and musculoskeletal disorders. Recently, the role of the central nervous system has proven to be an integral part on the development of any chronic pain syndrome, including CPPS. However, owing to the complex and heterogeneous etiology and pathophysiology of CPPS, the establishment of effective therapeutic interventions remains challenging for both physicians and patients. Nonetheless, recent studies have pointed that medicinal plants and their secondary metabolites can be effectively used in CPPS therapy, besides contributing to restore the patients' quality of life and potentiate the conventional CPPS management. In this sense, this review aims to provide a careful overview on the biomedical data for the use of medicinal plants use and their secondary metabolites on CPPS management.

Vitamin D microencapsulation and fortification: Trends and technologies.

Today, as per the latest medical reports available, majority of the population throughout globe is facing vitamin D (Vit D) deficiency. Even in sub-tropical countries like India and many others Vit D deficiency is highly prevalent despite the exuberant available sunshine (a major source of Vit D) throughtout the year. The reason could be attributed to an array of factors including socioeconomical, cultural and religious. Further, other than the sunlight, there are very limited sources of Vit D to fulfil the recommended dietary allowance of Vit D (RDA: 400-800 IU per day). A large proportion of Vit D is lost during food processing and storage due to environmental stress conditions such as temperature, pH, salt, oxygen and light. Vita D, an important micronutrient, is essentially required for the prevention of disorders such as neurodegenerative diseases, cardiovascular diseases, cancer etc. in addition to its traditional role in bone metabolism. Therefore, in order to meet the daily requirements of Vit D for human body, WHO has recognized fortification as the most efficient and safest method to address malnutrition. But there are innumerable chellenges involved during food fortification using Vit D as fortificants such as homogeneity into the food matrix, physico-chemical/photochemical degradation, loss during processing and storage, interactions with other components of food matrix resulting into change in taste, texture and appearance thus affecting acceptability, palatability and marketability. Fortification of Vit D into food products especially the ones which have an aqueous portion, is not simple for food technologist. Recent advances in nanotechnology offer various microencapsulation techniques such as liposome, solid-lipid particles, nanostructured lipid carriers, emulsion, spray drying etc. which have been used to design efficient nanomaterials with desired functionality and have great potential for fortification of fortificants like Vit D. The present review is an undate on Vit D, in light of its fortification level, RDA, factors affecting its bioavailability and various microencapsulation techniques adopted to develop Vit D-nanomaterials and their fate in food fortification.

Improved in vitro models for preclinical drug and formulation screening focusing on 2D and 3D skin and cornea constructs.

The present overview deals with current approaches for the improvement of in vitro models for preclinical drug and formulation screening which were elaborated in a joint project at the Center of Pharmaceutical Engineering of the TU Braunschweig. Within this project a special focus was laid on the enhancement of skin and cornea models. For this reason, first, a computation-based approach for in silico modeling of dermal cell proliferation and differentiation was developed. The simulation should for example enhance the understanding of the performed 2D in vitro tests on the antiproliferative effect of hyperforin. A second approach aimed at establishing in vivo-like dynamic conditions in in vitro drug absorption studies in contrast to the commonly used static conditions. The reported Dynamic Micro Tissue Engineering System (DynaMiTES) combines the advantages of in vitro cell culture models and microfluidic systems for the emulation of dynamic drug absorption at different physiological barriers and, later, for the investigation of dynamic culture conditions. Finally, cryopreserved shipping was investigated for a human hemicornea construct. As the implementation of a tissue-engineering laboratory is time-consuming and cost-intensive, commercial availability of advanced 3D human tissue is preferred from a variety of companies. However, for shipping purposes cryopreservation is a challenge to maintain the same quality and performance of the tissue in the laboratory of both, the provider and the customer.

Protocol: changes in rates of opioid overdose and poisoning events in an integrated health system following the introduction of a formulation of OxyContin® with abuse-deterrent properties.

BACKGROUND: Addiction, overdoses and deaths resulting from prescription opioids have increased dramatically over the last decade. In response, several manufacturers have developed formulations of opioids with abuse-deterrent properties. For many of these products, the Food and Drug Administration (FDA) recognized the formulation with labeling claims and mandated post-marketing studies to assess the abuse-deterrent effects. In response, we assess differences in rates of opioid-related overdoses and poisonings prior to and following the introduction of a formulation of OxyContin® with abuse-deterrent properties. METHODS/DESIGN: To assess effects of this formulation, electronic medical record (EMR) data from Kaiser Permanente Northwest (KPNW) and Kaiser Permanente Northern California (KPNC) are linked to state death data and compared to chart audits. Overdose and poisoning events will be categorized by intentionality and number of agents involved, including illicit drugs and alcohol. Using 6-month intervals over a 10-year period, trends will be compared in rates of opioid-related overdoses and poisoning events associated with OxyContin® to rates of events associated with other oxycodone and opioid formulations. Qualitative interviews with patients and relatives of deceased patients will be conducted to capture circumstances surrounding events. DISCUSSION: This study assesses and tracks changes in opioid-related overdoses and poisoning events prior to and following the introduction of OxyContin® with abuse-deterrent properties. Public health significance is high because these medications are designed to reduce abuse-related behaviors that lead to important adverse outcomes, including overdoses and deaths.

The effect of the European traditional use directive on the register of herbal medicinal products in Spain / Efecto en España de la directiva Europea de uso tradicional sobre el registro de medicamentos a base de plantas

Background: Directive 2004/24/EC, which came into force in 2011, created new regulatory requirements for traditional herbal medicines (THM). This study compared the Spanish THM registry before and after the Directive came fully into force in 2011. Methods: We consulted the herbal medicinal plant and drug catalogues (General Council of the Official Colleges of Pharmacists), the website of the European Medicines Agency (EMA), and retail web sites. Results: Of 315 THM (from 39 companies) licensed in Spain in 2010, only 48 (10 companies) remained licensed in 2013, mainly due to their withdrawal: the EMA had received just 123 applications from Spain and at least 34% formerly licensed THM had shifted to the less strictly regulated food sector, while up to 54% might have disappeared from the market. However, there is still a significant presence of retail websites making illegal health claims. Conclusion: In Spain, the public health benefits of the Directive 2004/24/EC might be less than expected (AU)

Antecedentes: En 2011 entró totalmente en vigor la Directiva 2004/24/CE, que impone nuevos requerimientos a los medicamentos tradicionales a base de plantas. Este trabajo analiza el efecto sobre su registro en España. Métodos: Se consultaron los catálogos de plantas medicinales y de medicamentos (CGCOF), la página web de la Agencia Europea del Medicamento (EMA) y sitios de venta en Internet. Resultados: De los 315 medicamentos a base de plantas autorizados en 2010, procedentes de 39 compañías; solo quedaban 48 (10 compañías) en 2013 por renuncia de la mayoría: sólo 123 solicitudes fueron recibidas a la EMA y al menos un 34% se pasó al sector de alimentación (menos estrictamente regulado). Hasta un 54% podría no comercializarse actualmente. Sin embargo, existe una presencia significativa de sitios web anunciando ilegalmente propiedades saludables para sus productos. Conclusión: Los beneficios de la Directiva 2004/24/CE para la salud pública española podrían ser menos de los esperados (AU)

[Review of traditional Chinese medicine processed by fermentation].

The fermentation processing of traditional Chinese medicines (TCMs), as an important processing method for TCM, originated from the ancient brewing technology. It has a long history in China. Fermented TCMs (FTCMs) are widely applied among folks for preventing and treating many diseases. There are many kinds of TCM processed by spontaneous fermentation, including Massa Medicata Fermentata, Rhizoma Pinelliae Fermentata, Red fermented rice, Semen Sojae Praepaaratum, Mass Galla chinesis et camelliae Fermentata and Pien Tze Huang. This essay summarizes historical origin, main varieties, the effect of microbial strains, current processing techniques and existing problems of FTCM, and look into the prospect of modern development of FTCMs.

Improvement of an encapsulation process for the preparation of pro- and prebiotics-loaded bioadhesive microparticles by using experimental design.

The purpose of this study was to design a new vaginal bioadhesive delivery system based on pectinate-hyaluronic acid microparticles for probiotics and prebiotics encapsulation. Probiotic strains and prebiotic were selected for their abilities to restore vaginal ecosystem. Microparticles were produced by emulsification/gelation method using calcium as cross-linking agent. In the first step, preliminary experiments were conducted to study the influence of the main formulation and process parameters on the size distribution of unloaded microparticles. Rheological measurements were also performed to investigate the bioadhesive properties of the gels used to obtain the final microparticles. Afterwards an experimental design was performed to determine the operating conditions suitable to obtain bioadhesive microparticles containing probiotics and prebiotics. Experimental design allowed us to define two important parameters during the microencapsulation process: the stirring rate during the emulsification step and the pectin concentration. The final microparticles had a mean diameter of 137µm and allowed a complete release of probiotic strains after 16h in a simulated vaginal fluid at +37°C.

Estudio jurisprudencial de la responsabilidad legal del personal sanitario en la reformulación de medicamentos / common law study of the legal responsability of health care staff related to drug reformulation

Objetivo: Analizar la responsabilidad del personal sanitario alelaborar reformulaciones (modificación de la dosis, forma farmacéuticao vía de administración de especialidades farmacéuticas)desde la jurisprudencia del Tribunal Supremo y la AudienciaNacional.Método: Búsqueda y análisis de jurisprudencia y estudios jurídicosen las bases de datos “El Derecho”, “Difusión Jurídica” e“Indret”.Resultados: El personal sanitario tiene una obligación demedios –no de resultados– aplicando unas normas de cuidadoque constituyen la “Lex Artis”, y que pueden ir más allá de lasmeras normas jurídicas. La falta a estas normas de cuidado, ladenegación de auxilio o la falta de respeto a la autonomía delpaciente pueden ser comportamientos negligentes. Se encontraron4 casos en la jurisprudencia. En los dos casos en que secumplieron las normas de cuidado, incluyendo la reformulación,los profesionales sanitarios fueron absueltos, mientras queen otros dos casos en que no se aplicaron reformulaciones,cuando las “Lex Artis” así lo imponía, los profesionales fueroncondenados.Conclusiones: La reformulación de especialidades farmacéuticas,incluidas en la Lex Artis, es una práctica aceptada por elTribunal Supremo y la Audiencia Nacional, siendo causa de condenael no recurrir a las mismas cuando los conocimientos científicosdel momento así lo aconsejen

Objective: To analyze the responsibility of health care staff indrug reformulation (change of dose, pharmaceutical form or routeof administration of medicinal products) based on the commonlaw of the High Court and the National Court.Method: Search and analysis of common law and legal studiesincluded in databases “El Derecho”, “Difusión Jurídica” and“Indret”.Results: Health care staff has means –not outcomes– obligationsaccording to the care standards included in the “Lex Artis”that can go beyond the mere legal standards. Failure to apply thiscare standards, denial of assistance or disrespect to the autonomyof the patient can be negligent behaviors. We found 4 cases incommon law. In the two cases in which care standards were compliedwith, including reformulation, health care professionals wereacquitted, whereas in the other two cases in which reformulationswere not used even though the “Lex Artis” required them, theprofessionals were condemned.Conclusions: Reformulation of medicinal products, as setforth in the Lex Artis, is a practice accepted by the High Courtand the National Court and failure to use it when the scientificknowledge advises so is a cause for conviction