Polymer coated polymeric microneedles for intravitreal delivery of dexamethasone.

The polymer coated polymeric (PCP) microneedles (MNs) is a novel approach for controlled delivery of drugs (without allowing release of the excipients) to the target site. PCP MNs was explored as an approach to deliver the drug intravitreally to minimize the risks associated with conventional intravitreal injections. The core MNs was fabricated with polyvinyl pyrrolidone K30 (PVP K30) and coating was with Eudragit E100. Preformulation studies revealed that the films prepared using Eudragit E 100 exhibited excellent integrity in the physiological medium after prolonged exposure. FTIR studies were performed to investigate the possible interaction between the API and the polymer. The PCP MNs fabricated with different drug loads (dexamethasone sodium phosphate) were subjected to in vitro drug release studies. The drug release from uncoated MNs was instantaneous and complete. On the other hand, a controlled release profile was observed in case of PCP MNs. Likewise, even in the ex vivo porcine eye model, the drug release was gradual into the vitreous humor in case of PCP MNs. The uncoated microneedles released all the drug instantaneously where the PCP MNs retarded the release up to 3 h.

Continuous Manufacturing of Oil in Water (O/W) Emulgel by Extrusion Process.

Pharmaceutical industries and drug regulatory agencies are inclining towards continuous manufacturing due to better control over the processing conditions and in view to improve product quality. In the present work, continuous manufacturing of O/W emulgel by melt extrusion process was explored using lidocaine as an active pharmaceutical ingredient. Emulgel was characterized for pH, water activity, globule size distribution, and in vitro release rate. Additionally, effect of temperature (25°C and 60°C) and screw speed (100, 300, and 600 rpm) on the globule size and in vitro release rate was studied. Results indicated that at a given temperature, emulgel prepared under screw speed of 300 rpm resulted in products with smaller globules and faster drug release.

Polymer-Coated Polymeric (PCP) Microneedles for Controlled Dermal Delivery of 5-Fluorouracil.

Polymeric microneedles were prepared with Polyvinyl Pyrrolidone (PVP) K-30 using the mold casting technique. The core microneedles were coated with Eudragit E-100 by dip and spin method. The amount of 5-fluorouracil (FU) loaded in the core microneedles was 604 ± 35.4 µg. The coating thickness was 24.12 ± 1.12 µm. The objective was to deliver the 5-FU gradually in a controlled release manner at the target site in the sub-stratum corneum layer. This approach is anticipated to improve the safety and efficacy of topical melanoma treatment. The release of the drug was prolonged for up to 3 h from the polymer-coated polymeric (PCP) microneedles. The entire amount was found to release within 15 min in uncoated MNs. Likewise, the permeation of the drug from the uncoated microneedles was rapid, whereas the PCP microneedles were able to prolong the permeation up to 420 min. The PCP microneedles were subjected to stability studies at 25°C ± 2°C/60%RH, and 40°C ± 2°C/75%RH condition for 3 months. The formulations were found intact, and the release rate was not significantly different form the fresh formulation. The drug content was found to meet the acceptability criteria as well (98.12 ± 1.8% and 97.8 ± 2.1% at 25 and 40°C respectively after 3 months). Overall, this study demonstrated the feasibility of fabrication of PCP microneedles using Eudragit E100 for intraregional controlled delivery of drugs.

Prenatal care reduces the impact of illicit drug use on perinatal outcomes.

OBJECTIVE: To estimate the extent that prenatal care (PNC) retains its protective influence against prematurity, low birth weight (LBW), and small for gestational age (SGA) status in infants exposed to illicit drug use (IDU) in pregnancy. STUDY DESIGN: This was a prospective cohort analysis including 6673 women residents of the District of Columbia (Washington, DC, USA) delivering at four city hospitals. Women were screened in the immediate postpartum period. Levels of PNC were established according to American College of Obstetrics and Gynecology guidelines and the Kotelchuck index. PNC and IDU were compared between subgroups. Adjusted relative risks for prematurity, LBW and SGA, controlling for maternal and gestational ages, were calculated in different groups according to IDU and level of PNC. RESULTS: IDU was identified in 13% of mothers screened. PNC was classified as none (6%), inadequate (10%), intermediate (20%), and adequate (64%). The highest risk for prematurity, LBW, or SGA occurred in infants born to mothers with no PNC and positive IDU in pregnancy (prematurity OR=12.05, 95% CI: 8.99 to 16.16; LBW OR=14.76, 95% CI: 11.03 to 19.75; SGA OR=9.20, 95% CI: 5.32 to 15.92). As PNC levels increased, significant reductions in risk for prematurity and LBW (not for SGA) in IDU-exposed infants were observed. Risk for SGA in IDU-exposed infants reduced significantly when PNC was introduced. CONCLUSIONS: In infants exposed to IDU, a reduction in risk for prematurity, LBW, and SGA, was consistently demonstrated with improved levels of PNC. In high-risk populations, health care should seek to reach mothers early, especially those identified at risk for IDU, and deliver PNC to them effectively.

The effect of a parenting education program on the use of preventive pediatric health care services among low-income, minority mothers: a randomized, controlled study.

OBJECTIVE: To determine if a community-based intervention program focusing on parenting education will have an impact on preventive health care utilization behaviors among low-income, minority mothers in Washington, DC. DESIGN: The experimental design was a randomized, controlled study in which 286 mother-infant dyads were assigned to either the standard social services (control) group or to the intervention group. Women and their newborn infants were recruited during the immediate postpartum period in 4 Washington, DC, hospital sites from April 1995 to April 1997. The year-long multicomponent intervention included home visits and hospital-based group sessions in addition to the standard social services available at the hospital sites. A total of 286 postpartum women with inadequate prenatal care were assigned randomly to the control or the intervention group. Women and their infants were followed for 1 full year. Outcome measures included usage of preventive health care services including well care infant visits and adherence to immunization schedules during the first year of the infant's life. RESULTS: Infants in the intervention group initiated well care at an earlier age than controls (by 6 weeks, 62.5% vs 50% had received their first well infant visit). Infants in the intervention group had more frequent well visits (by 12 months of age, 3.5 vs 2.7 visits). Multivariate analyses showed infants in the intervention group to be more likely to complete their scheduled immunizations (by 9 months, odds ratio = 2.2, 95% confidence interval: 1.09-4.53). Those in the intervention group with more frequent contacts (30+ visits) with study personnel were most likely to have followed age-appropriate immunization schedules when compared with controls (at 9 months odds ratio = 3.63, 95% confidence interval: 1.58-8.33). CONCLUSIONS: It is possible to influence health care usage patterns of high-risk minority populations through public health interventions that are global in their perspective. Focusing on parental knowledge and beliefs regarding health-related issues and life skills in a self-efficacy model is associated with improved usage of infant health care resources.