Therapeutic proteins as biopharmaceuticals have emerged as a very important class of drugs for the treatment of many diseases. However, they are less stable compared to conventional pharmaceuticals. ...Their long-term stability in solid forms, which is critical for product performance, depends heavily on the retention of the native protein structure during the lyophilization (freeze-drying) process and, thereafter, in the solid state. Indeed, the biological function of proteins is directly related to the tertiary and secondary structure. Besides physical stability and biological activity, conformational stability (three-dimensional structure) is another important aspect when dealing with protein pharmaceuticals. Moreover, denaturation as loss of higher order structure is often a precursor to aggregation or chemical instability. Careful study of the physical and chemical properties of proteins in the dried state is therefore critical during biopharmaceutical drug development to deliver a final drug product with built-in quality that is safe, high-quality, efficient, and affordable for patients. This review provides an overview of common analytical techniques suitable for characterizing pharmaceutical protein powders, providing structural, and conformational information, as well as insights into dynamics. Such information can be very useful in formulation development, where selecting the best formulation for the drug can be quite a challenge.
Tacrolimus-loaded modified nanolipid carrier (T-MNLC) achieved long-term therapeutic success due to site-specific delivery of anti-inflammatory agent, tacrolimus and restoration of skin barrier ...properties by proper hydration thereby preventing repeated episodes of inflammation in atopic dermatitis.
In atopic dermatitis (AD), topical anti-inflammatory therapy with skin barrier restoration to prevent repeated inflammatory episodes leads to long-term therapeutic success. Tacrolimus, although effective against AD, is a challenging molecule due to low solubility, low-penetration, poor-bioavailability, and toxicity. Part I of this paper, reported novel modified nanolipid carrier system for topical delivery of tacrolimus (T-MNLC), offering great opportunity to load low-solubility drug with improved entrapment efficiency, enhanced stability and improved skin deposition. Present investigation focused on restoration of skin barrier, site-specific delivery, therapeutic effectiveness, and safety of novel T-MNLC. T-MNLC greatly enhanced occlusive properties, skin hydration potential and reduced transepidermal water loss. This might help to reduce the number of flares and better control the disease. Cutaneous uptake and drug deposition in albino rats by HPLC and confocal laser scanning microscopy revealed prominently elevated drug levels in all skin strata with T-MNLC as compared to reference. T-MNLC demonstrated efficient suppression of inflammatory responses in BALB/c mice model of AD. Safety assessment by acute and repeated-dose dermal toxicity demonstrated mild keratosis and collagenous mass infiltration at the treatment area with repeated application of reference. Interestingly, T-MNLC showed no evident toxicity exhibiting safe drug delivery. Thus, novel T-MNLC would be a safe, effective, and esthetically appealing alternative to conventional vehicles for treatment for AD.
Objective To evaluate the drug information cards in drug safety management in clinical settings. Methods A set of cards contains image and specification of drug were designed and applied in drug ...safety management in clinical settings. The condition of drug safety management was evaluated before implementation (from Jan, 2015 to December 2015) and after implementation (from Jan, 2016 to December 2016). Results The rate of awareness on oral medication among patients increased from 56. 00% before implementation to 94. 67% after implementation. The rate of compliance with oral medication among patients increased from 92. 20% before implementation to 99. 40% after implementation. The rate of implementation of health education on medication among nurses increased from 80. 50% before implementation to 99. 40% after implementation. Conclusion The application of drug information cards is help to increase pharmacological knowledge level of nurses and reduce medication error. (目的 探讨口服药图集卡在临床安全用药管理中的应用效果。方法 制作口服药图集卡, 比较2015年1月—12月口服药图集卡使用前和2016年1月—12月口服药图集卡使用后的安全用药管理情况。结果 2016年使用口服药物图集后, 患者对口服药物知识知晓率由2015年的56. 00%提高为94. 67%, 患者口服给药依从性由2015年的89. 40%提升为98. 60%, 患者住院满意率由2015年的92. 20%提升为99. 40%, 护士对患者用药健康教育执行率由2015年80. 5%提高到99. 4%。结论 口服药图集卡的应用有助于提高护士对药理知识的掌握水平, 对减少用药差错有重要意义。)
Incorporating the pH-sensitivity of octylamine grafted poly aspartic acid (PASP) with the biocompatibility of liposomes, a novel pH sensitive drug delivery system, octylamine-graft-PASP (PASP-g-C8) ...modified liposomes (OPLPs), was obtained. Since hydrophobic chains have been grafted into PASP backbones, the octylamine chain could act as the "anchor" to implant onto liposomes. The structure of PASP-g-C8, involving long-chain and hydrophobic anchors can significantly enhance the stability of the drug carrier. The shortcoming of single PASP chain modified liposomes (PLPs), that cannot sustain a slow and controlled release especially in a physiological pH solution (resembling normal tissues of pH 7.4) is thus overcome. Drug release experiments were carried out and the result showed that OPLPs sustained a slow and steady release in comparison with PLPs in the physiological pH 7.4 environment. However, OPLPs can provide a fast release in subacid environment (pH 5.0 of resembled tumor tissues). The results of diameter analysis and zeta potential demonstrated that OPLPs presented a larger diameter and higher electronegativity. Furthermore, in the "chain-anchor" structure of PASP-g-C8, the degree of substitution (DS) of the "anchor" is a remarkable factor to alter the pH-sensitivity of OPLPs. The in vitro tumor inhibition and cell toxicity studies revealed that tumor cells treated with OPLPs survived only 35.0% after 48 h whereas normal cells survived 100% in the same condition. The pH sensitive OPLPs are promising tumor targeting drug delivery with high tumor inhibition and insignificant cytotoxicity.
Interprofessional collaborative patient‐centered care (IPCPC) improves healthcare quality and cost. Drug‐related morbidity drives healthcare costs, thus requiring IPCPC approaches. The lack of ...educational preparedness for would‐be IPCPC practitioners underlies the failure of historic IPCPC attempts, hence today's emphasis on pre‐licensure interprofessional education (IPE). A pilot IPE class was conducted on rational drug use (RDU) through rational drug prescribing. Twenty fourth‐year nursing students and 88 second‐year medical students participated (8–10 medical per 2–3 nursing students) in small group activity in a lecture hall. A case study on rational drug choice and prescription writing processes from medical and nursing perspectives was used. Eighty of 108 (74%) students completed the post‐activity questionnaire and were satisfied with the class, with a mean weighted score (mws) of 0.8. The learning outcomes (mws = 1.0) contributed more (P < 0.05) to students satisfaction than the organization/delivery (mws = 0.6). A majority (84–94%) agreed the class objectives were achieved and favored more classes. Interaction with other healthcare professionals and the crowded classroom were, respectively, the most‐ and least‐liked aspects of the class. The study revealed students' appetite for IPE, highlights the challenges in developing IPE curricula, and could serve as impetus for schools developing IPE for RDU curricula.
Mesalazine is a safe drug, although adverse events may be seen in a minority of patients. This applies also to pregnant women and children. The role of mesalazine in combination therapy to improve ...efficacy and concomitant drug pharmacokinetics, or in chemoprevention against-inflammatory bowel disease （IBD）-related colonic carcinoma has not yet been completely elucidated. Therapeutic success of mesalazine may be optimized by a combination of high dose and low frequency of dosage to improve compliance. Therefore, due to its superior safety profile and pharmacokinetic characteristics, mesalazine is preferable to sulphasalazine. This paper reviews the literature concerning mechanisms of action, indications and off-label use, pharmacokinetic properties and formulations, therapeutic efficacy, compliance, paediatric indications, chemoprevention, and safety issues and adverse event profile of mesalazine treatment versus sulphasalazine. It also highlights these controversies in order to clarify the potential benefits of mesalazines in IBD therapy and evidence for its use.
Purpose: This study aimed to investigate the safe medication utilization and the education demands during pregnancy and it further reported the development of educational materials for pregnant ...women.
Methods: A survey was conducted in two tertiary care university hospitals and one community hospital specialized in obstetrics and gynecology from July 2 to 29 2014. The survey questionnaires included the usage of medications and the unmet needs on medication use during pregnancy. Ad ditionally, pregnant women’s requests regarding to medication use were collected through group interviewing of community pharmacists. Based on these results, educational materials were de veloped and implemented. After implementing the education sessions, the satisfaction was evaluated.
Results: A total of 152 pregnant women answered completely the questionnaire. Among them, 130 participants (42.8%) were given the medication information from their physicians. Exposure to a teratogenic drug during pregnancy was a major concern for most pregnant women (79.6%). The majority (90.1%) of subjects reported a necessity of medication-related education during their pregnancy. The interview with 48 pharmacists indicated that the most commonly used OTC drugs in pregnancy were vitamins (25.2%), iron supplements (23.7%), and the most frequently used prescription drugs were antiinflammatory-analgesics (25.3%), followed by antibiotics (20.9 %). Based on the results, booklets of drug therapy during pregnancy, leaflet of pregnancy category index were made. Also, on-line flash and presentation materials for instructors were prepared. Through the trial education with the developed materials, it was confirmed that the contents of education materials were well understood and satisfied by the pregnant women.
Conclusions: This study showed the need of the medication-related education for the pregnant women. The developed education materials would be helpful sources to provide accurate and reliable medication-related information to health professionals and pregnant women.
Many oral chemotherapy agents have been approved over the last 15 years and are displacing or augmenting parenteral chemotherapy. As 8,000 Baby Boomers turn 65 years of age every day, more elders ...will migrate to long-term care and assisted living facilities, and consultant pharmacists may need to manage chemotherapy for the first time. Though many therapeutic classes of oral drugs are hazardous, the majority of oral chemotherapy agents are hazardous by virtue of their mechanisms of action. Previous hazardous drug-handling recommendations from the Occupational Safety and Health Administration, the National Institute of Occupational Safety and Health, the American Society of Health-System Pharmacists, the American Society of Clinical Oncology, the Hematology/Oncology Pharmacy Association, and the Oncology Nursing Society have matured into new standards from the United States Pharmacopeial Convention (USP), Chapter , "Hazardous Drugs-Handling in Health Care Settings." These standards provide a comprehensive approach for safe drug handling across all health care settings and underscore the need for consultant pharmacist involvement in nursing and assisted living facilities.
Amiodarone (AD) is an effective antidysrythmic drug, however, there can be serious side effects, such as hepatic and neurological alterations, as well as skin photosensitization, as seen in ...porphyrias. Clinical signs in porphyrias might be triggered by the so-called porphyrinogenic drugs. Without sound basis, Amiodarone has been classified as an unsafe drug for porphyric patients. The aim of this work has been to study the effect of AD, both in vivo and in vitro, on heme metabolism. In the in vivo assays, the activities of 5-aminolevulinate synthetase (ALA-S), ALA dehydratase (ALA-D), porphobilinogenase (PBGase) and PBG-deaminase (PBG-D) in blood, liver, and kidney; hepatic and fecal porphyrins, urinary ALA, PBG and porphyrins in male mice strain CF1 treated with AD (100 mg i.p. daily) for 1 week and 1 month, were measured. No significanat differences were found for any of these parameters in the AD treated animals as compared to controls. In the in vitro experiments human bood, and mice blood, liver, and kidney, were used to measure the activities of ALA-S, ALA-D, PBGase, PBG-D and uroporphyrinogen decarboxylase, in the presence of varying concentrations of AD (0.0172–4.304 mM). AD did not modify any of the enzyme activities. All of the above biochemical parameters were studied in 17 cardiac patients under AD treatment for 3 to 20 years. Neither the activieis of the heme enzymes, nor the levels of precursors and porphyrins in urine and plasma were altered. These findings clearly demonstrate that AD is a pharmacologically safe drug and can be used for the treatment of associated pathologies in porphyrias.
Abstract
Antidiabetic medications are commonly used around the world, but their safety is still unclear. The aim of this study was to investigate whether long-term use of insulin and oral ...antidiabetic medications is associated with cancer risk.
We conducted a well-designed case–control study using 12 years of data from Taiwan's National Health Insurance Research Database and investigated the association between antidiabetic medication use and cancer risk over 20 years. We identified 42,500 patients diagnosed with cancer and calculated each patient's exposure to antidiabetic drugs during the study period. We matched cancer and noncancer subjects matched 1:6 by age, gender, and index date, and used Cox proportional hazard regression and conditional logistic regression, adjusted for potential confounding factors, that is, medications and comorbid diseases that could influence cancer risk during study period.
Pioglitazone (adjusted odds ratio AOR, 1.20; 95% confidence interval CI, 1.05–1.38); and insulin and its analogs for injection, intermediate or long acting combined with fast acting (AOR, 1.22; 95% CI, 1.05–1.43) were significantly associated with a higher cancer risk. However, metformin (AOR, 1.00; 95% CI, 0.93–1.07), glibenclamide (AOR, 0.98; 95% CI, 0.92–1.05), acarbose (AOR, 1.06; 95% CI, 0.96–1.16), and others do not show evidence of association with cancer risk. Moreover, the risk for specific cancers among antidiabetic users as compared with nonantidiabetic medication users was significantly increased for pancreas cancer (by 45%), liver cancer (by 32%), and lung cancer (by 18%).
Antidiabetic drugs do not seem to be associated with an increased cancer risk incidence except for pioglitazone, insulin and its analogs for injection, intermediate or long acting combined with fast acting.
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