Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents

<p>Abstract</p> <p>Background</p> <p>Accurately monitoring adherence to treatment with recombinant human growth hormone (r-hGH) enables appropriate intervention in cases of poor adherence. The electronic r-hGH auto-injector, easypod™, automatically records the patient's adherence to treatment. This study evaluated adherence to treatment of children who started using the auto-injector and assessed opinions about the device.</p> <p>Methods</p> <p>A multicentre, multinational, observational 3-month survey in which children received r-hGH as part of their normal care. Physicians reviewed the recorded dose history and children (with or without parental assistance) completed a questionnaire-based survey. Children missing ≤2 injections per month (92% of injections given) were considered adherent to treatment. Adherence was compared between GH treatment-naïve and treatment-experienced children.</p> <p>Results</p> <p>Of 834 recruited participants, 824 were evaluated. The median (range) age was 11 (1-18) years. From the recorded dose history, 87.5% of children were adherent to treatment over the 3-month period. Recorded adherence was higher in treatment-naïve (89.7%, n = 445/496) than in treatment-experienced children (81.7%, n = 152/186) [Fisher's exact test FI(X) = 7.577; <it>p </it>= 0.0062]. According to self-reported data, 90.2% (607/673) of children were adherent over 3 months; 51.5% (421/817) missed ≥1 injection over this period (mainly due to forgetfulness). Concordance between reported and recorded adherence was 84.3%, with a trend towards self-reported adherence being higher than recorded adherence. Most children liked the auto-injector: over 80% gave the top two responses from five options for ease of use (720/779), speed (684/805) and comfort (716/804). Although 38.5% (300/780) of children reported pain on injection, over half of children (210/363) considered the pain to be less or much less than expected. Given the choice, 91.8% (732/797) of children/parents would continue using the device.</p> <p>Conclusions</p> <p>easypod™ provides an accurate method of monitoring adherence to treatment with r-hGH. In children who received treatment with r-hGH using easypod™, short-term adherence is good, and significantly higher in treatment-naïve children compared with experienced children. Children/parents rate the device highly. The high level of acceptability of the device is reflected by a desire to continue using it by over 90% of the children in the survey.</p

Topical semi-solid drug delivery: kinetics and tolerance of ophthalmic hydrogels

The efficacy of ophthalmic semi-solid hydrogels is mostly based on an increase of ocular residence time, via enhanced viscosity and mucoadhesive properties. Preformed and in particular in situ gelling systems improve bioavailability and decrease the side effects induced by the systemic absorption of topically applied ophthalmic drugs. Since increased viscosity often causes the discomfort of blurred vision and foreign body sensation, it is important to assess the optimal range of viscosity as well as the most suitable rheological behavior which will ensure good efficacy and tolerance

In vitro characterization of a novel polymeric-based pH-sensitive liposome system

AbstractThis study demonstrates rapid and pH-sensitive release of a highly water-soluble fluorescent aqueous content marker, pyranine, from egg phosphatidylcholine liposomes following incorporation of N-isopropylacrylamide (NIPA) copolymers in liposomal membranes. The pH-sensitivity of this system correlates with the precipitation of the copolymers at acidic pH. In vitro release can be significantly improved by increasing the percentage of anchor in the copolymer and thus favoring its binding to the liposomal bilayer. In the case of liposomes containing a poly(ethylene glycol)–phospholipid conjugate, the insertion of the pH-sensitive copolymer in the liposomal membrane appears to be sterically inhibited. Dye release from these formulations at acidic pH can still be achieved by varying the anchor molar ratio and/or molecular mass of the polymers or by including the latter during the liposome preparation procedure. Removal of unbound polymer results in decreased leakage only when the copolymer is inserted by incubation with preformed liposomes, but can be overcome by preparing liposomes in the presence of polymer. Aqueous content and lipid mixing assays suggest contents release can occur without membrane fusion. The results of this study indicate that the addition of pH-sensitive copolymers of NIPA represents promising strategy for improving liposomal drug delivery

Ocular drug delivery in veterinary medicine

This paper provides a comprehensive overview of the various approaches currently used in the development of ocular drug delivery systems for the treatment of ocular diseases in animals. It is obvious from the literature that most of the products that are currently available are derived from human medicine without consideration given to the differences which exist between the anatomy and physiology of the eye of various animal species which ultimately affect product design and performance. As a result, many of the products for animal use seem in many circumstances inappropriate for animal care. The article deals with some aspects of eye anatomy and physiology of different animals, and then provides an overview of the most commonly encountered pathologies. The paper then discusses the currently available drug products and finally reviews new delivery concepts. Several hundred references are included in the paper and provide access to further information on the subject

Improved biocompatibility of a viscous bioerodible poly(ortho ester) by controlling the environmental pH during degradation

The poly(ortho ester), POE, used in this investigation, is a viscous bioerodible polymer (8 kDa), which rapidly degrades into a triol and an acidic by-product, acetic acid. In order to improve biocompatibility, we have evaluated the addition of various basic excipients, such as sodium acetate, hydroxyapatite, calcium carbonate and magnesium hydroxide, which buffered and neutralized the acidic degradation product and prolonged the polymer lifetime and drug release. This decrease of POE degradation rate results in a decreased rate of formation of the acidic by-product. Similarly, a POE of higher molecular weight (14 kDa) has been tested. Sodium acetate was too hydrophilic to affect the drug release and the biocompatibility of the polymer, whereas the presence of magnesium hydroxide markedly prolonged the drug release and improved the acceptability of the polymer. The increased molecular weight POE did not improve biocompatibility and a similar but delayed, inflammatory reaction was observed