The Impact of Food on Bioavailability of Oxycodone Myristate: A Case Report.

BACKGROUND: In efforts to reduce misuse of opioids, new abuse deterrent formulations of medications have been developed. Insurers increasingly give abuse-deterrent opioid formulations preferred formulary status, which can result in required formulation rotation for patients. Xtampza® (oxycodone myristate extended-release) is an abuse-deterrent opioid formulation that maintains its extended-release properties with any physical manipulation. Blood levels of oxycodone myristate extended-release (OxyM-ER) may vary with dietary caloric and fat intake. CASE DESCRIPTION: A woman with metastatic breast carcinoma had severe myalgias and arthralgias well-managed with oxycodone hydrochloride extended-release (OxyHCl-ER) and hydrocodone/acetaminophen. A switch from OxyHCl-ER to OxyM-ER resulted in worsened pain management, decreased functional status, and a referral to palliative care (PC). Recognizing calorie-depending pharmacokinetic variability with OxyM-ER, the interdisciplinary PC team obtained a detailed dietary history from the patient, which revealed a low-fat, low-calorie healthy diet with inconsistent meals. After repeated education, the patient changed her diet and had improved pain and functional status without increasing her total daily opioid dose. CONCLUSION: The efficacy of OxyM-ER may be compromised in patients with cancer experiencing anorexia, decreased or inconsistent food intake, or low-fat/low-calorie diets. An interdisciplinary team approach can improve pain control in the setting of "forced" formulary switches to OxyM-ER.

Head lice.

INTRODUCTION: Head louse infection is diagnosed by finding live lice, as eggs take 7 days to hatch (but a few may take longer, up to 13 days) and may appear viable for weeks after death of the egg. Infestation may be more likely in school children, with risks increased in children with more siblings or of lower socioeconomic group. Factors such as longer hair make diagnosis and treatment more difficult. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of physically acting treatments for head lice? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found six studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review, we present information relating to the effectiveness and safety of the following interventions: 1,2-octanediol, dimeticone, herbal and essential oils, and isopropyl myristate.

Effectiveness of isopropyl myristate/cyclomethicone D5 solution of removing cuticular hydrocarbons from human head lice (Pediculus humanus capitis).

BACKGROUND: In the treatment of human head lice infestation, healthcare providers are increasingly concerned about lice becoming resistant to existing pesticide treatments. Traditional pesticides, used to control these pests, have a neurological mechanism of action. This publication describes a topical solution with a non-traditional mechanism of action, based on physical disruption of the wax layer that covers the cuticle of the louse exoskeleton. This topical solution has been shown clinically to cure 82% of patients with only a 10-minute treatment time, repeated once after 7 days. All insects, including human head lice, have a wax-covered exoskeleton. This wax, composed of hydrocarbons, provides the insect with protection against water loss and is therefore critical to its survival. When the protective wax is disrupted, water loss becomes uncontrollable and irreversible, leading to dehydration and death. A specific pattern of hydrocarbons has been found in all of the head louse cuticular wax studied. Iso-octane effectively removes these hydrocarbons from human head lice's cuticular wax. METHODS: A method of head louse cuticle wax extraction and analysis by gas chromatography was developed. Human head lice (Pediculus humanus capitis) were collected from infested patients and subjected to any of three extraction solvents comprising either the test product or one of two solvents introduced as controls. A gas chromatograph equipped with a flame ionization detector (GC/FID) was used to determine the presence of hydrocarbons in the three head lice extracts. RESULTS: In the study reported herein, the test product isopropyl myristate/cyclomethicone D5 (IPM/D5) was shown to perform comparably with iso-octane, effectively extracting the target hydrocarbons from the cuticular wax that coats the human head louse exoskeleton. CONCLUSIONS: Disruption of the integrity of the insect cuticle by removal of specific hydrocarbons found in the cuticular wax appears to offer a mechanism for killing lice without the likelihood of encountering genetic resistance.

Efficacy of anti-wrinkle products in skin surface appearance: a comparative study using non-invasive methods.

BACKGROUND/PURPOSE: Age has a huge influence on skin roughness; with increasing age, the number of collagen and elastine fibers is reduced and elasticity decreases significantly. Pharmaceutical and cosmetics, environmental factors and lifestyle have an important effect on skin. In this study, the efficacy of 12 commercial anti-wrinkle products was evaluated using a direct non-invasive method to measure the skin surface morphology. Four clinical parameters surface evaluation of the living skin (SELS) (Ser, Sesc, Sesm, and Sew) were evaluate using Visioscan(®) VC98. METHODS: Two hundred and forty-eight healthy female volunteers, aged between 30 and 70 years, were chosen for this study. The duration of treatment was 28 days. Skin microrelief parameters were evaluated using the Visioscan(®) VC98 - SELS 2000 from Courage+Khazaka. Measurements were made in the crow's feet area and the differences were evaluated for statistical significance. RESULTS: Significant differences were found for some of the SELS parameters. According to the results obtained for SELS Sew, products that showed to be more effective against aging were V, M, N, T, P, R and L. We think this methodology may be considered very useful for the direct study of the skin surface and may be suitable as a routine method in wrinkle evaluation.

North American efficacy and safety of a novel pediculicide rinse, isopropyl myristate 50% (Resultz).

BACKGROUND: Head lice infestations are a major nuisance in school-aged children and are a worldwide public health problem. There are growing concerns about the effectiveness of current treatments owing to increasing resistance, safety, and patient noncompliance. A safe, easy to use, effective alternative is needed. OBJECTIVE: A pediculicide rinse, 50% isopropyl myristate (IPM), was assessed in two phase 2 trials conducted in North America. The first trial was a nonrandomized (proof of concept) trial without a comparator conducted in Winnipeg, Canada. The second trial, conducted in the United States, was an evaluator-blinded, randomized superiority trial comparing 50% IPM rinse with a positive control (RID; pyrethrin 0.33%, piperonyl butoxide 4%). The primary end points were to determine the safety and efficacy of 50% IPM as a pediculicide rinse. METHODS: Subjects meeting inclusion criteria were enrolled in the above-mentioned trials with efficacy end points 7 and 14 days post-treatment. Subjects were also evaluated on days 0, 7, 14, and 21 for the presence of erythema and edema using the Modified Draize Scale. Other comments associated with the safety evaluation (ie, pruritus) were collected. RESULTS: IPM was found to be effective in the proof of concept study and comparator trial using a positive control. IPM was also well tolerated, with minimal adverse events. All adverse events were mild, resolving by completion of the study. CONCLUSION: Data suggest that IPM is a safe and effective therapy for the treatment of head lice in children and adults. IPM's mechanical mechanism of action makes development of lice resistance unlikely.

The HIV-1 Tat transactivator protein: a therapeutic target?

The human immunodeficiency virus-1 (HIV-1), the causative agent of autoimmune deficiency syndrome (AIDS) is a major health problem world-wide. Central to HIV infection is the transactivator protein Tat, that plays a critical role in the nucleus during the HIV infectious cycle, by binding the transactivation-responsive region (TAR) and thereby enhancing transcriptional elongation. Tat appears to gain nuclear entry through a novel mechanism, independent of the normal cellular importin/Ran-dependent pathways, and regulated by a cytoplasmic retention mechanism. Since blocking Tat nuclear import is likely to prevent HIV infection, detailed delineation of Tat's nuclear import pathway is critical to assessing its viability as a therapeutic target. Other feasible anti-HIV therapies include approaches to inhibit Tat-TAR interaction.