Use In Drug Delivery Devices Research Articles

Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone: A multicenter, 2-Month, single-arm, open-label clinical trial in patient-caregiver dyads

Background: Improved ease of use of drug-delivery devices may enhance compliance. Development of an easier-to-use device for administration of recombinant human growth hormone (rhGH) may thus be beneficial for patients and their caregivers. Objective: This study compared ease of use and preference for a new disposable rhGH injection pen relative to previous experience with the currently available reusable pen in standard practice. Both pens deliver the same formulation of rhGH. Methods: This multicenter, single-arm, open-label study assessed ease of use and preference for the 2 injection pens in patient-caregiver dyads. Eligible children were aged 8 through 18 years, were currently being treated with rhGH, and had been compliant with use of the current reusable pen for ≥3 months before study entry. A validated self-reported Injection Pen Assessment Questionnaire was administered twice during the study—at baseline (to assess perceptions of the reusable pen) and after 2 months of use of the new disposable pen—to assess ease of use of the individual pens (rated on a 5-point Likert-type scale), the comparative ease of use of the 2 pens, and pen preference. The primary end point was the proportion of dyads who rated the new pen as no different or easier to use than the current pen. Regardless of treatment or suspected causal relationship to the investigational product, all observed or volun- teered adverse events (AEs) were recorded and rated as mild, moderate, or severe. Results: Of 137 screened dyads, 136 (91 boys, 45 girls) were included in the safety population and 133 were included in the efficacy population. The children had a mean age of 12.3 years, a mean weight of 42.2 kg, a mean height of 145.9 cm, and a mean body mass index of 19.3 kg/m 2; 84.6% of the children were white. The majority (82.4%) of adult dyad members were subjects' mothers. The adult dyad members were more likely than the child members to be responsible for preparing the injection (82.0%) and administering the injection (72.9%). Overall, 73.7% of dyads rated the new disposable pen no different or easier to use than the reusable pen (95% CI, 66.2%–81.2%), and 65.2% rated the disposable pen no different or preferable to the reusable pen (95% CI, 57.0%–73.3%). Overall, 60 all-causality AEs occurred in 28 subjects (20.6%), most of them (93.3%) either mild or moderate in intensity. Eight device-related AEs occurred in 7 subjects (5.1%) (injection-site hematoma in 3 and injection-site pain in 5). The most common AEs were headache (7 events), injection-site pain (5), upper respiratory tract infection (4), and pyrexia (4). No deaths or serious AEs were reported. Conclusions: Nearly three quarters of patients and caregivers reported that the new disposable pen was no Accepted for publication October 1, 2010. different or easier to use than the reusable pen, and nearly two thirds preferred the disposable pen. No safety concerns were identified. The findings suggest that the improvements in the new pen were recognized by patients and caregivers.

Lactic and Glycolic Acid based Polymers for use in Biomedical Applications

Keeping in view the potential of biodegradable polymers for different biomedical applications, in the present study, an attempt has been made to synthesize the poly(lactic acid), poly(glycolic acid) and poly(lactic-co-glycolic acid) based polymer matrices and thereafter use in drug delivery devices. The polymers and copolymers thus prepared were characterized by SEMs, FTIR, swelling studies (as a function of time, pH, temperature and [NaCl]), hydrolytic and biocompatibility studies. The Non-Fickian diffusion mechanism has been observed for the release of a model drug (famotidine) from these polymer matrices. It has been observed that hydrolytic degradation of polymeric matrix is strongly influenced by the pH of the medium and nature of the polymer matrix.

Retinoids: new use by innovative drug-delivery systems

Background: Retinoids represent an old class of bioactives used in the treatment of different skin pathologies (such as acne and psoriasis) and in the treatment of many tumors. Unfortunately, they present several side effects, i.e., burning of skin and general malaise after systemic administration and they are very unstable after exposition to light. Methods: One of the most promising new approaches for reducing the side effects of retinoids while improving their pharmacological effect is the use of drug-delivery devices. This review explains the current status of retinoid drug transport, which has been developing over the last few years, explaining the modification of their biopharmaceutical properties in detail after encapsulation/inclusion in vesicular and polymeric systems. Results/conclusion: Different colloidal and micellar systems containing retinoid drugs have been realized furnishing important potential advancements in traditional therapy.

Colloidal carriers for the enhanced delivery through the skin

Background: The skin is the largest organ of our body and acts as a protective barrier with sensory and immunological functions. Its peculiar structure influences the passage of bioactives and only its modulation can facilitate the drug dermal/transdermal diffusion. In the past few years research in this field has assured better use of this application area. Methods: One of the most promising approaches is the use of drug delivery devices; this review explains the state of the art of drug transport through the skin by means of vesicular (classic liposomes, Transfersomes, niosomes and ethosomes) and particulate systems. Results/conclusion: Colloidal drug delivery systems are important in the field of drug delivery systems as their different characteristics make them suitable for various purposes.

Non-photolithographic pattern transfer for fabricating arrayed three-dimensional microstructures by chemical anisotropic etching

We propose a new fabrication process for different types of microneedle structures on silicon wafers that does not use photolithography technology. The process consists of anisotropic wet etching and a dicing technology using a dicing saw, and it does not require any expensive plasma-based equipment. We fabricated several arrayed microneedle structures for use in drug delivery devices in medical application. The needle height ranged from 100 to 400 μm, and the distance between the two needles was 70–200 μm.

Microstructural Characterization of Polyanhydride Blends for Controlled Drug Delivery

AbstractThis research examines the microstructure of polyanhydride blends for use in drug delivery devices. Atomic force microscopy (AFM) and small-angle X-ray scattering (SAXS) studies were performed on the homopolymers and blends of the polyanhydrides poly(1,6-carboxyphenoxy hexane) (CPH) and poly(sebacic anhydride) (SA). AFM of the CPH/SA blends 20:80, 50:50, and 80:20 showed distinct patterns indicating spinodal decomposition and phase separation on the micron-scale. Because it has been shown that incorporated drugs will thermodynamically partition into phase-separated domains depending on their hydrophobicity, polyanhydride blends will be able to encapsulate larger bioactive compounds including nucleotides, proteins, and vaccines. Preliminary SAXS studies of the CPH/SA blend systems provide information on the crystalline morphology of the polymer. A peak shift to a lower q from poly(SA) to the blends indicates that the poly(CPH) is incorporated into and causes swelling of the interlamellar amorphous regions of poly(SA).