Prediction of Drug Dissolution Profiles Using Artificial Neural Networks

This paper investigates the efficacy and reliability of Artificial Neural Networks (ANNs) as an intelligent decision support tool for pharmaceutical product formulation. Two case studies have been employed to evaluate capabilities of the Multilayer Perceptron network in predicting drug dissolution/release profiles. Performances of the network were evaluated using similarity factor (&fnof[sub 2]) — an index recommended by the United States Food and Drug Administration for profile comparison in pharmaceutical research. In addition, the bootstrap method was applied to assess the network prediction reliability by estimating confidence intervals associated with the results. The Multilayer Perceptron network also demonstrated a superior performance in comparison with multiple regression models. The results reveal that the ANN system has potentials to be a decision support tool for profile prediction in pharmaceutical experimentation, and the bootstrap method could be used as a means to assess reliability of the network prediction. [ABSTRACT FROM AUTHOR].

Clinical association between pharmacogenomics and adverse drug reactions

Adverse drug reactions (ADRs) are a major public health concern and cause significant patient morbidity and mortality. Pharmacogenomics is the study of how genetic polymorphisms affect an individual’s response to pharmacotherapy at the level of a whole genome. This article updates our knowledge on how genetic polymorphisms of important genes alter the risk of ADR occurrence after an extensive literature search. To date, at least 244 pharmacogenes identified have been associated with ADRs of 176 clinically used drugs based on PharmGKB. At least 28 genes associated with the risk of ADRs have been listed by the Food and Drug Administration as pharmacogenomic biomarkers. With the availability of affordable and reliable testing tools, pharmacogenomics looks promising to predict, reduce, and minimize ADRs in selected populations.

Manufacturing techniques and surface engineering of polymer based nanoparticles for targeted drug delivery to cancer

The evolution of polymer based nanoparticles as a drug delivery carrier via pharmaceutical nano/microencapsulation has greatly promoted the development of nano- and micro-medicine in the past few decades. Poly(lactide-co-glycolide) (PLGA) and chitosan, which are biodegradable and biocompatible polymers, have been approved by both the Food & Drug Administration (FDA) and European Medicine Agency (EMA), making them ideal biomaterials that can be advanced from laboratory development to clinical oral and parental administrations. PLGA and chitosan encapsulated nanoparticles (NPs) have successfully been developed as new oral drug delivery systems with demonstrated high efficacy. This review aims to provide a comprehensive overview of the fabrication of PLGA and chitosan particulate systems using nano/microencapsulation methods, the current progress and the future outlooks of the nanoparticulate drug delivery systems. Especially, we focus on the formulations and nano/micro-encapsulation techniques using top-down techniques. It also addresses how the different phases including the organic and aqueous ones in the emulsion system interact with each other and subsequently influence the properties of the drug delivery system. Besides, surface modification strategies which can effectively engineer intrinsic physicochemical properties are summarised. Finally, future perspectives and potential directions of PLGA and chitosan nano/microencapsulated drug systems are outlined.

Nanoparticulate drug delivery to colorectal cancer : formulation strategies and surface engineering

The evolution of polymer-based nanoparticle as a drug delivery carrier has greatly contributed to the development of advanced nano and micro-medicine in the past few decades. The polymer-based nanoparticles of biodegradable and biocompatible polymers such as poly (lactide-co-glycolide) and chitosan which have been approved by Food & Drug Administration and/or European Medicine Agency can particularly facilitate the maintaining of specific properties for a real transition from laboratory to the clinical oral and parental administration. This review presents an overview of the strategies of preparing polymeric nanoparticles and using them for targeting colorectal cancer. Theranostics and surface engineering aspects of nanoparticle design in colonic cancer delivery are also highlighted.

The relationship between residence and the pharmacological management of challenging behavior in individuals with intellectual disability

Many individuals with intellectual disability are administered psychotropic drugs to manage their challenging behavior. The increased relocation of individuals from institutions into community-based accommodation during the past decade provides an opportunity to examine the relationship between setting and drug administration. This study provides acomparison of drug use according to the type of residential facility of 873 individuals reported to have been administered drugs for behavioral restraint in March 2000, with 762 individuals reported in March 1993. In 2000, individuals in institutions were reported toreceive a moderately greater number of drugs concurrently than those in the community. However, there were no differences in the proportion of individuals prescribed drugs relative to the total population living in the respective settings. This is in contrast to the findings from 1993, where drug use was greater in individuals who were living in institutions. It was also more common for individuals who continued to be medicated across time to have previously lived in an institution. Although relocation into the community may be associated with improved living conditions, it is important to recognize that this change in living conditions is not necessarily associated with less use of drugs to manage behavior.

Use of medical orders in acute care oxygen therapy

The life of every living organism is sustained by the presence of oxygen and the acute deprivation of oxygen will, therefore, result in hypoxia and ultimately death. Although oxygen is normally present in the air, higher concentrations are required to treat many disease processes. Oxygen is therefore considered to be a drug requiring a medical prescription and is subject to any law that covers its use and prescription. Administration is typically authorized by a physician following legal written instructions to a qualified nurse. This standard procedure helps prevent incidence of misuse or oxygen deprivation which could worsen the patients hypoxia and ultimate outcome. Delaying the administration of oxygen until a written medical prescription is obtained could also have the same effect. Clearly, defined protocols should exist to allow for the legal administration of oxygen by nurses without a physicians order because any delay in administering oxygen to patients can very well lead to their death.

Reaching and influencing consumers in the prescription medicine market

Purpose – Celebrex became the first of a new class of drugs known as COX-2 selective non-steroidal anti-inflammatory drugs. It improves treatment for arthritis sufferers without compromising the protective lining of the stomach. The purpose of this paper is to illustrate how direct-to-consumer advertising (DTCA) of prescription medicines can be used to rebuild faith in the cyclooxygenase-2 (COX-2) product category.

Design/methodology/approach – The case is developed using published sources and no input is required from company representatives. The presentation style follows the classic comprehensive case format used in postgraduate teaching programmes.

Findings – Business executives and strategic marketing students would benefit from a discussion on how external environmental factors can suddenly impose a review of marketing strategy. The reader learns how management addresses the business dilemma using DTCA.

Research limitations/implications – A blockbuster rival drug Vioxx is withdrawn due to cardiovascular (CV) health safety concerns. A resulting dominant market situation soon becomes a business dilemma. The Federal Drug Administration calls for a “black box” warning label on Celebrex, the most serious type of warning.

Practical implications – The implications are that having a product in a class of its own is not enough. It highlights the need to communicate to different audiences, to both the medical profession and the end-user. Getting doctors to recommend the medicine and pulling the product through the channel by stimulating patient demand after a health scare are paramount.

Originality/value – This is the first pharmaceutical business case where the withdrawal of a rival product leaves the dominant competitor in a monopoly situation. Contrary to expectation, market share plummets despite the absence of competition.

Advances in the treatment of malignant gliomas

Local control with surgery, radiation, and temozolomide chemotherapy remain the pillars of treatment for high-grade gliomas. Novel therapeutic strategies, including a variety of antiangiogenic agents, are under investigation. One of these agents, bevacizumab, was recently given accelerated approval by the US Food and Drug Administration as a single agent for recurrent glioblastoma. Recent trial results are generating important clinical questions regarding which patients to treat and when, and how best to monitor response. Encouraging results of recent studies are driving willingness to undertake aggressive treatment and to improve outcomes in this population. In this era, better understanding of biology, molecular aspects of cancer, and clinical trial methodology are crucial for clinicians. This review focuses on recent advances in the treatment malignant gliomas, especially antiangiogenic therapy.

Debating the evidence : oral contraceptives containing drospirenone and risk of blood clots

Skepticism is an essential quality in science. We doubt, re-examine and demand the highest quality of evidence. However, sometimes this puts us in an awkward situation. How much evidence do we need before we act? This dilemma is a constant problem in drug safety. Treatment decisions are always a balance of risks and benefits and there may be a paucity of evidence about rare or very rare adverse events.

The Pharmaceutical Industry and Access to Medicines in India

Pharmaceutical policy in India as elsewhere is shaped by conflicting economic and social interests and opposing values and priorities. Tensions can be understood as revolving around the contradiction between use value and exchange value in the production of medicinal drugs as commodities, as per Marx’s original analysis. The use value of medicines – if safe and efficacious, of good quality, and prescribed and consumed appropriately – is the prevention, cure or alleviation of ill-health and disease. Health policy is – or should be – aimed at optimising the use value of medicines. For this purpose government agencies administer regulatory oversight of the manufacturing, marketing and distribution of medicines. Drugs made available to patients are expected to meet adequate safety, quality and efficacy standards, but regulation to ensure such standards is subject to controversy in most countries. This is a domain where definition and interpretation of scientific-technological principles and criteria is infused by partiality and bias grounded in social and material interests, as evidenced by recurrent debates about industry ‘capture’ of regulatory agencies, including the world’s most regulator, the US Food and Drug Administration (Angell 2005; Law 2006). In India, a Parliamentary Committee Report in 2012 depicted the Central Drugs Standard Control Organisation (CDSCO) as dysfunctional and influenced inappropriately by the exchange value perspective of manufacturers (Parliamentary Standing Committee on Health and Welfare 2012). The clash between use and exchange value perspectives is starkly illustrated by cases of products known to cause more harm than good, particularly common in poorly regulated markets such as India’s, as shown by Srinivasan & Phadke.

Brain targeted PLGA nanocarriers alleviating amyloid-Β expression and preserving basal survivin in degenerating mice model

The chronic systemic administration of d-Galactose in C57BL/6J mice showed a relatively high oxidative stress, amyloid-β expression and neuronal cell death. Enhanced expression of pyknotic nuclei, caspase-3 and reduced expression of neuronal integrity markers further confirmed the aforesaid insults. However, concomitant treatment with the recombinant protein (SurR9-C84A) and the anti-transferrin receptor antibody conjugated SurR9-C84A (SurR9+TFN) nanocarriers showed a significant improvement in the disease status and neuronal health. The beauty of this study is that the biodegradable Food and Drug Administration (FDA) approved poly(lactic-co-glycolic acid) (PLGA) nanocarriers enhanced the biological half-life and the efficacy of the treatments. The nanocarriers were effective in lowering the amyloid-β expression, enhancing the neuronal integrity markers and maintaining the basal levels of endogenous survivin that is essential for evading the caspase activation and apoptosis. The current study herein reports for the first time that the brain targeted SurR9-C84A nanocarriers alleviated the d-Galactose induced neuronal insults and has potential for future brain targeted nanomedicine application.

Intranasal naloxone for the treatment of suspected heroin overdose

AIMS: This paper reviews available literature regarding the effectiveness, safety and utility of intranasal (i.n.) naloxone for the treatment of heroin overdose.

METHODS: Scientific literature in the form of published articles during the period January 1984 to August 2007 were identified by searching several databases including Medline, Cinahl and Embase for the following terms: naloxone, narcan, intranasal, nose. The data extracted included study design, patient selection, numbers, outcomes and adverse events.

RESULTS: Reports of the pharmacological investigation and administration of i.n. naloxone for heroin overdose are included in this review. Treatment of heroin overdose by administration of i.n. naloxone has been introduced as first-line treatment in some jurisdictions in North America, and is currently under investigation in Australia.

CONCLUSION: Currently there is not enough evidence to support i.n. naloxone as first-line intervention by paramedics for treatment of heroin overdose in the pre-hospital setting. Further research is required to confirm its clinical effectiveness, safety and utility. If proved effective, the i.n. route may be useful for drug administration in community settings (including peer-based administration), as it reduces risk of needlestick injury in a population at higher risk of blood-borne viruses. Problematically, naloxone is not manufactured currently in an ideal form for i.n. administration.

Medication management by graduate nurses: before, during and following medication administration

The purpose of the present study was to explore graduate nurses' perceptions of their medication management activities in the acute care context. A qualitative research design with a semistructured interview schedule was used to elicit information from participants. The sampling population consisted of graduate nurses involved in direct patient care in medical and surgical wards of a Melbourne metropolitan teaching hospital, completing a graduate nurse program. Twelve graduate nurses participated in the interviews. Two major themes emerged: (i) monitoring medications and (ii) interventions for patient care. The findings indicate that graduate nurses are required to address several facets of the medication management role in their daily practice. It is pertinent to examine ward dynamics to ensure that graduate nurses have ready access to experienced health care professionals. Through collegial support, graduate nurses should also be encouraged to critically examine the different possibilities when making clinical judgments about monitoring patient medications.

Mapping drug calculation skills in an undergraduate nursing curriculum

The ability to calculate drug dosages correctly is an essential skill for registered nurses to possess. Performing drug calculations accurately is not a skill that new graduates have the luxury of developing over time. Drug errors are in many instances directly related to either the administration of an incorrect dose or incorrect infusion rate (Gladstone, 1995) caused by calculation errors. A strategy for implementing drug calculation skills into our new under graduate nursing curriculum was initiated to assist students in developing proficiency in drug calculations. The aim of this program is to promote the development of calculation skills in undergraduate nursing students, rather than simply assessing their skills.

Nursing administration of medication via enteral tubes in adults : a systematic review

Background Enteral tubes are frequently inserted as part of medical treatment in a wide range of patient situations. Patients with an enteral tube are cared for by nurses in a variety of settings, including general and specialised acute care areas, aged care facilities and at home. Regardless of the setting, nurses have the primary responsibility for administering medication through enteral tubes. Medication administration via an enteral tube is a reasonably common nursing intervention that entails a number of skills, including preparing the medication, verifying the tube position, flushing the tube and assessing for potential complications. If medications are not given effectively through an enteral tube, harmful consequences may result leading to increased morbidity, for example, tube occlusion, diarrhoea and aspiration pneumonia. There are resultant costs for the health-care system related to possible increased length of stay and increased use of equipment. Presently what is considered to be best practice to give medications through enteral tubes is unknown.

Objectives The objective of this systematic review was to determine the best available evidence on which nursing interventions are effective in minimising the complications associated with the administration of medications via enteral tubes in adults. Nursing interventions and considerations related to medication administration included form of medication, verifying tube placement before administration, methods used to give medication, methods used to flush tubes, maintenance of tube patency and specific practices to prevent possible complications related to the administration of enteral medications.

Search strategy The following databases were searched for literature reported in English only: CINAHL, MEDLINE, The Cochrane Library, Current Contents/All Editions, EMBASE, Australasian Medical Index and PsychINFO. There was no date restriction applied. In addition, the reference lists of all included studies were scrutinised for other potentially relevant studies.

Selection criteria Systematic reviews of randomised controlled trials (RCTs) and RCTs that compared the effectiveness of nursing interventions and considerations used in the administration of medications via enteral tubes. Other research methods, such as non-randomised controlled trials, longitudinal studies, cohort and case control studies, were also included. Exclusion criteria included studies investigating drug–nutrient interactions or the bioavailability of specific medications.

Data collection and analysis Initial consideration of potential relevance to the review was carried out by the primary author (NP). Two reviewers independently assessed study eligibility for inclusion. A meta-analysis could not be undertaken, as there were no comparable RCTs identified. All data were presented in a narrative summary.

Results There is very limited evidence regarding the effectiveness of nursing interventions in minimising the complications associated with enteral tube medication administration in adults. The review highlights a lack of high quality research on many important nursing issues relating to enteral medication administration. There is huge scope for further research. Some of the evidence that was identified included that nurses should consider the use of liquid form medications as there may be fewer tube occlusions than with solid forms in nasoenteral tubes and silicone percutaneous endoscopic gastronomy tubes. Nurses may need to consider the sorbitol content of some liquid medications, for example, elixirs, as diarrhoea has been attributed to the sorbitol content of the elixir, not the drug itself. In addition, the use of 30 mL of water for irrigation when administering medications or flushing small-diameter nasoenteral tubes may reduce the number of tube occlusions.