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PubMed2003

Progress in the delivery of therapeutic oligonucleotides: organ/cellular distribution and targeted delivery of oligonucleotides in vivo.

Oligonucleotide (ODN) therapy is a powerful tool for modulation of gene expression in vivo. With advances in ODN chemistry and progress in formulation development, ODNs are becoming widely acceptable drugs. This review summarizes the current status and future trend of the in vivo application of ODN therapeutics, especially antisense ODNs. Here, we review the current understanding of the tissue/organ distribution and cellular uptake of ODN drugs administered parenterally or nonparenterally to intact animals. The problems and advantages inherent in the use of different delivery methods for the treatment of particular diseases are discussed in detail. Emphasis is placed on the most widely studied ODN analogs, the phosphorothioates (PS). Lessons learned from antisense PS studies have broad implications for ODN therapeutics in general.

Animals↗
PubMed2001

In-vitro nasal drug delivery studies: comparison of derivatised, fibrillar and polymerised collagen matrix-based human nasal primary culture systems for nasal drug delivery studies.

The aim of this study was to establish a collagen matrix-based nasal primary culture system for drug delivery studies. Nasal epithelial cells were cultured on derivatised (Cellagen membrane CD-24), polymerised (Vitrogen gel) and fibrillar (Vitrogen film) collagen substrata. Cell morphology was assessed by microscopy. The cells were further characterised by measurement of ciliary beat frequency (CBF), transepithelial resistance (TER), permeation of sodium fluorescein, mitochondrial dehydrogenase (MDH) activity and lactate dehydrogenase (LDH) release upon cell exposure to sodium tauro-24, 25 dihydrofusidate (STDHF). Among the three collagen substrata investigated, the best epithelial differentiated phenotype (monolayer with columnar/cuboidal morphology) occurred in cells grown on Cellagen membrane CD-24 between day 4 and day 11. Cell culture reproducibility was better with Cellagen membrane CD-24 (90%) in comparison with Vitrogen gel (70%) and Vitrogen film (< 10%). TER was higher in cells grown on Vitrogen gel than on Cellagen membrane CD-24 and Vitrogen film. The apparent permeability coefficient (Papp x 10(-7)cm s(-1)) of sodium fluorescein in these conditions was 0.45+/-0.08 (Vitrogen gel) and 1.91+/-0.00 (Cellagen membrane CD-24). Except for LDH release, CBF and cell viability were comparable for all the substrata. Based on MDH activity, LDH release, CBF, TER and permeation studies, Cellagen membrane CD-24- and Vitrogen gel-based cells were concluded to be functionally suitable for in-vitro nasal drug studies. Vitrogen film-based cultures may be limited to metabolism and cilio-toxicity studies.

Administration, Intranasal↗
PubMed1999

Delivery of erythromycin to subcutaneous tissues in rats by means of a trans-phase delivery system.

Topical administration of antibiotics is associated with reduced risk of systemic side-effects and alteration of gut microflora, and results in higher concentrations of antibiotics at the site of application (and so a lower dose of the drug is required). In conditions such as acne vulgaris, infiltration of the antibiotics into the infected subcutaneous layers is highly desirable. A trans-phase delivery system (TPDS), a mixture of benzyl alcohol, acetone and isopropanol, has been shown to enhance the effective transport of the antibiotic erythromycin across the epidermal barrier and enhance accumulation in the dermis. Two formulations containing N-methyl[14C]erythromycin were compared, a TPDS solution and a propylene glycol solution. They were applied to the dorsal areas of 4-6 week old Fischer rats and tissues were removed for analysis of radioactivity after 2, 4, 8, 12 or 24 h and skin was biopsied and sectioned for autoradiography. The erythromycin dissolved in the TPDS solvent mixture penetrated the stratum corneum and a relatively high concentration was maintained in adjacent tissues for up to 24 h. Penetration was very effective and the erythromycin was detected in significant amounts in the underlying muscle, various organs and later in the urine. In contrast the propylene glycol carrier, probably because of its primarily hydrophilic character, caused the erythromycin to traverse tissue barriers rapidly and appear in the urine. Microautoradiographs qualitatively revealed progressive disappearance of radioactivity from the surface; this correlated with results obtained by direct isotope counting. The route of penetration, in addition to following the interkeratinocyte spaces, seemed to include the perimeter of the pilosebaceous glands and their appendages before diffusion into the capillaries. The propylene glycol solution seemed to traverse the epidermis and the papillary and reticular dermis more rapidly, which might explain its rapid appearance in the urine. These data suggest that the different solutions penetrate the skin by different mechanisms.

Administration, Cutaneous↗
PubMed2001

Development of a new aerosol delivery system for systemic pulmonary delivery in anaesthetized and orotracheal intubated rats.

Over the last decade, the systemic absorption of a broad range of therapeutics after pulmonary application has been demonstrated in animals as well as in humans. The most common method used in the laboratory is the intratracheal instillation of drugs in solution. This method is, however, unsatisfactory, because of discrepancies in particle distribution, clearance, kind of injury and bioavailability between instillation and inhalative application. On the other hand, a precise determination of the amount of drug applied by aerosol, and of the aerosol volume retained within the lungs is rather difficult, and is not possible for use with small animals such as mice or rats. We describe a system which allows the delivery of aerosols directly into the animal's lungs, and calculation of the amount of drug retained in the lungs. Our system was tested in vitro and in vivo and was shown to allow precise and efficient pharmacokinetic and toxicological studies to be carried out.

Absorption↗
PubMedDate not supplied

Therapeutic delivery systems: a new approach to evaluate physical properties of transdermal delivery systems (TDS).

In the present paper a new methodological setup to objectify the parameters adhesiveness and adhesive strengths of Transdermal Delivery Systems is presented. The setup includes 6 steps: Evaluation of skin type, application of the patch by a pneumatic device, evaluation of detached area of the patch by planimetric means, assessment of the adhesive strength by a patch removal unit, evaluation of reddening of the skin, and examination for water uptake of the skin layers by high resolution ultrasound. Each step is described individually. Further problems arising from studies performed with this methodological setup concerning possible adhesive-drug interactions as well as uncorrelated drug behavior to nondetached area of the patch with regard to the pharmacokinetic profile are discussed.

Administration, Cutaneous↗
PubMed1989

Delivery of the low birthweight and the very low birthweight breech: cesarean section or vaginal delivery?

We studied neonatal survival rates, APGAR scores, and length of hospital stay in 199 singleton breeches weighing 1000-2500 grams at birth. We found that in the birthweight range of 1000-1750 grams, breeches who were delivered by cesarean section had a significantly higher survival rate (74%) than those who were delivered vaginally (36%, p less than 0.01), however, in the birthweight range of 1751-2500 grams, there was no significant difference in the survival rates between breeches delivered abdominally and those delivered vaginally. The 1-minute and the 5-minute APGAR scores and the length of the hospital stay were not significantly different between the abdominal and the vaginal delivery groups in either birthweight range. The data indicate that the very low birthweight breech (less than or equal to 1750 grams) may benefit from a prophylactic cesarean section.

Apgar Score↗
PubMedDate not supplied

The Microsponge Delivery System (MDS): a topical delivery system with reduced irritancy incorporating multiple triggering mechanisms for the release of actives.

The Microsponge Delivery System (MDS) is a unique technology for the controlled release of topical agents and consists of macroporous beads, typically 10-25 microns in diameter, loaded with active agent. When applied to the skin, the MDS releases its active ingredient on a time mode and also in response to other stimuli (rubbing, temperature, pH, etc). MDS technology is being used currently in cosmetics, over-the-counter (OTC) skin care, sunscreens and prescription products. By delivering the active gradually to the skin, MDS-benzoyl peroxide formulations, for example, have excellent efficacy with minimal irritation. These are typical benefits from the use of the MDS.

Acne Vulgaris↗
PubMed2004

[An alternative in childbirth education: vaginal delivery following earlier cesarean delivery].

The cesarean rate in Taiwan, at 33.10 percent, is the third highest in the world. Many women who have had a cesarean section for one birth opt to do so for all subsequent deliveries. The VBAC (vaginal birth after c-section) is defined as a vaginal birth subsequent to a cesarean birth. Many women remain skeptical about VBAC, but education can do much to dispel their doubts. Currently, the childbirth education provided by most hospitals in Taiwan is designed solely for women expecting a vaginal birth; it takes no account of those who have previously had a cesarean birth and are considering a vaginal birth. This article describes the current situation as regards VBAC, the reasons why it needs to become a more widespread practice, the necessity for childbirth education to cover the aims and nature of VBAC, and the author's experiences, to serve as a reference for caregivers providing training in VBAC in order to benefit more women.

Cesarean Section↗
PubMed2005

UK childbirth delivery options in 2001-2002: alternatives to consultant unit booking and delivery.

BACKGROUND: Government policy advocates maternal choice in pregnancy care. Two key issues are place of birth and type of lead professional. Anecdotal evidence suggests there is variation in both these issues across the UK, but there has been no recent national assessment of whether maternal options are in line with government policy. AIM: To establish the range of women's childbirth delivery options, degree of midwife autonomy, and supporting training and governance mechanisms. DESIGN: Two postal questionnaires. SETTING: UK maternity units. METHOD: Questionnaires were sent to maternity services managers. MAIN OUTCOME MEASURES: number and type of units and births, transfers and care types; midwifery procedures; clinical governance and training activities. RESULTS: Completed questionnaires were received from 301 out of 308 (97.7%) units in 2002 and from 258 out of 309 (83.5%) units in 2001. Midwife-led care is available in 186 English (76.9%), 15 Welsh (78.9%), 18 Scottish (48.6%) and three Northern Ireland (30.0%) units. There are 73 (24.3%) stand-alone, 22 (7.3%) alongside, 127 (42.2%) integrated and 79 (26.2%) consultant units (for definitions of unit types, see main text), with a median 2215 hospital, 25 home and 210 midwife-led births. The median antenatal and labour transfers from midwife-led units are 25.5% (interquartile range [IQR] = 18.5-36.5%) and 18.0% (IQR = 13.4-24.8%) respectively; transfers are independent of distance to nearest consultant unit, country and unit type. CONCLUSIONS: Despite government policy promoting greater parental choice, this is not in evidence in many parts of the UK. The wide variations in home birth, midwife-led care and maternity-unit types merit further exploration. If more midwife-led units are to be established as a way of promoting parental choice and dealing with junior doctor rota problems, then such units must have adequate governance and training activities in place.

Appointments and Schedules↗
PubMed2006

Postpartum outcomes in supine delivery by physicians vs nonsupine delivery by midwives.

CONTEXT: Clinically preferred maternal position during childbirth has varied between supine and nonsupine over time and from patient to patient. Preferred maternal birthing position is coming under increasing scrutiny. OBJECTIVE: To compare postpartum maternal and infant outcomes resulting from supine and nonsupine positions maintained during the second stage of labor. DESIGN AND METHODS: Nonrandomized clinical trial comparing low-risk women (N=198) in two separate obstetrics practices. In one practice, parturients (n=100) used only the supine position as their birthing position. In the other practice, parturients (n=98) used any or all of three nonsupine positions (sitting, squatting, or kneeling/hands-and-knees). Data collection took place immediately after birth by provider survey and included: Apgar scores, demographics, estimated blood loss, neonatal weight, perineal integrity, position during second-stage labor and birth, and vulvar edema. RESULTS: Infants born to mothers in nonsupine positions were delivered with significantly less tearing of the perineum (P<.001) and less vulvar edema (P<.001). Although the length of second-stage labor was shorter among the women who were nonsupine, this result lacked statistical significance. There did not appear to be increased risk to the infant from the mother's nonsupine posture. CONCLUSION: Nonsupine positions during labor and delivery were found to have clinical advantages without risk to mother or infant. Enhanced maternal outcomes included improved perineal integrity, less vulvar edema, and less blood loss.

Delivery, Obstetric↗
PubMed1997

Recent trends in drug delivery systems: liposomal drug delivery system--preparation and characterisation.

Liposomes are potential drug carriers for variety of drugs, therapeutic proteins and diagnostic agents. Drug entrapment ability of liposomes makes it more useful in targetting of drugs to specific site within the body. Major components of liposomes include lipids, water, drugs, electrolytes, antioxidants, preservatives and viscosity inducing agents. Considering the widespread use of liposomes in drug therapy and problem of physico-chemical instabilities of liposomes, this article aims at giving an insight into various methods of preparation of different types of liposomes like, unilamellar and multilamellar vesicles, consideration of some critical aspects of manufacturing processes and the characterization of liposomal drug delivery system in reference to vesicle size distribution, determination of residual organic phase in the phospholipid bilayer system, per cent drug encapsulation and identification.

Drug Carriers↗
PubMed2006

Characterization of polymeric poly(epsilon-caprolactone) injectable implant delivery system for the controlled delivery of contraceptive steroids.

Contraceptive steroids levonorgestrel (LNG) and ethinyl estradiol (EE) have been encapsulated with poly(epsilon-caprolactone) (PCL) microspheres using a w / o /w double emulsion method. The microspheres prepared were smooth and spherical, with a mean size from 8-25 microm. In vitro release profiles of microspheres showed a trend of increasing initially at the first week, and thereafter the release was sustained. At the end of the seventh week LNG/EE from 1:5 and 1:10 PCL microspheres were 60 and 48%, 52 and 46%, respectively. An in vitro degradation study shows that at the 20th week the microspheres maintained the surface integrity. The PCL microspheres showed a triphasic in vivo release profile with an initial burst effect due to the release of the steroid adsorbed on the microsphere surface, a second sustained release phase due to the steroid diffusion through the pores or channels formed in the polymer matrix, and third phase due to polymer bioerodible. Histological examination of PCL microspheres injected intramuscularly into thigh muscle of a rat showed a minimal inflammatory reaction demonstrating that contraceptive steroid-loaded microspheres were biocompatible. The level of inflammatory cytokines determined by immunostaining for IL-1alpha, the tissue response to formulations at the first week was considered mild, whereas at the end of the 20th week the inflammatory response ceased. Thus, this study helped us to evaluate the feasibility of using these microspheres as a long-acting biodegradable drug delivery system for contraceptive steroids.

Animals↗
PubMed1988

Improved delivery through biological membranes. XXXL: Solubilization and stabilization of an estradiol chemical delivery system by modified beta-cyclodextrins.

A dihydropyridine in equilibrium pyridinium salt chemical delivery system (CDS) for estradiol (E2CDS) was complexed with various modified beta-cyclodextrins including hydroxyethyl-beta-cyclodextrin (HECD), hydroxypropyl-beta-cyclodextrin (HPCD), and heptakis(2,6-di-O-methyl)-beta-cyclodextrin (DMCD). Complex formation with all of these cyclodextrins resulted in dramatic increases in the water solubility of E2CDS. Studies on the complex of E2CDS and HPCD (E2CDS-CD) indicated that the encapsulated estrogen was approximately four times more stable than the unmanipulated CDS, producing an estimated half-life of degradation of 4 years compared with 1.2 years for the uncomplexed drug at room temperature. The complexation of E2CDS and HPCD also stabilized the dihydronicotinate in solutions containing potassium ferricyanide. This formulation was shown to be equivalent to E2CDS in dimethyl sulfoxide in delivering the oxidized, estradiol precursor (E2Q+) to the brain, and also produced similar biological responses; these included decreased luteinizing hormone (LH) secretion and a decrease in the rate of weight gain in castrated female rats.

Animals↗
PubMed1995

The delivery of aerosolized steroids from MDIs with nozzle extensions: quantitative laboratory evaluation of a method to improve aerosol delivery to intubated patients.

OBJECTIVE: Pulmonary deposition of aerosolized drug from a metered dose inhaler (MDI) is low with intubated patients. In the laboratory, extension of the MDI nozzle to the endotracheal tube tip has been shown to increase the delivered dose of albuterol. The objectives of this study were to determine the dose of aerosolized steroid (beclomethasone and triamcinolone) delivered through a MDI nozzle extension, the effect of nozzle extension length and number of actuations on the delivered dose, and particle size delivered through the nozzle extension. DESIGN: A 19-G catheter was used as the MDI nozzle extension. The nozzle extension was attached to a 60-ml syringe via the Luer-Lok connection, and the distal end was directed through a hole drilled into a 15-ml capped tube. The MDI was placed into the syringe and actuated by pressing the syringe plunger. Drug delivered through the nozzle extension into the tube was dissolved in methanol (beclomethasone) or ethanol (triamcinolone). Nozzle extension lengths of 10 cm, 20 cm and 30 cm were studied. For each nozzle extension length, delivery was assessed using one, two, three and five actuations of each drug. Drug remaining in the nozzle extension was recovered by rinsing with the appropriate solvent. Aerosol particle size leaving the nozzle extension was determined using a seven-stage cascade impactor. Beclomethasone and triamcinolone concentrations were determined by spectrophotometry at 239 nm. SETTING: Respiratory care laboratory of a university teaching hospital. RESULTS: For the pooled results, 70.2 +/- 14.1% of the dose was delivered through the nozzle extension, with no difference between beclomethasone and triamcinolone (p = 0.838). The proportion of drug delivered through the 10-cm extension (76.7 +/- 8.4%) was greater than that from the 20-cm (66.1 +/- 16.5%) and 30-cm (67.7 +/- 13.9%) extensions (p = 0.001). Less drug was delivered through the extension with one actuation (54.1 +/- 17.7%) than with two (71.2 +/- 7.7%), three (77.2 +/- 5.5%), or five actuations (78.2 +/- 4.3%) (p < 0.001). There was a decrease in MMAD with increasing nozzle extension length (3.14 +/- 0.61 microns for 10 cm, 2.97 +/- 0.28 microns for 20 cm, 2.37 +/- 0.27 microns for 30 cm; p = 0.005). CONCLUSIONS: A high proportion of aerosolized steroid was delivered with a MDI actuated through a nozzle extension. The proportion delivered through the nozzle extension was significantly less with longer nozzle extensions and with fewer actuations, but this may not be clinically important. Although particle sizes were smaller from longer nozzle extensions, all were within the respirable range. These results suggest that steroids can be delivered efficiently using a MDI nozzle extension.

Aerosols↗
PubMed1989

Tubal ligation at cesarean delivery in five Asian centers: a comparison with tubal ligation soon after vaginal delivery.

Increasingly more tubal sterilizations are being performed at the time of cesarean section in the United States and probably also in developing countries. This descriptive study provides us with hitherto unavailable information on the impact of this combined procedure on the women undergoing it. Five Asian centers were included for study. In these centers, 618 women had concurrent tubal ligation at cesarean section in 1973 and 1974. During this period, 3399 women had tubal ligation soon after term vaginal deliveries. The much higher morbidity and mortality in the former group were judged to be attributable to the indications leading to, or the complications of, cesarean section and not to the concurrent tubal ligation. Women undergoing the combined procedure of tubal ligation and cesarean section were more likely to have characteristics associated with later regretting the sterilization.

Adult↗
PubMed1994

Porous Tube Plant Nutrient Delivery System development: a device for nutrient delivery in microgravity.

The Porous Tube Plant Nutrient Delivery System or PTPNDS (U.S. Patent #4,926,585) has been under development for the past six years with the goal of providing a means for culturing plants in microgravity, specifically providing water and nutrients to the roots. Direct applications of the PTPNDS include plant space biology investigations on the Space Shuttle and plant research for life support in Space Station Freedom. In the past, we investigated various configurations, the suitability of different porous materials, and the effects of pressure and pore size on plant growth. Current work is focused on characterizing the physical operation of the system, examining the effects of solution aeration, and developing prototype configurations for the Plant Growth Unit (PGU), the flight system for the Shuttle mid-deck. Future developments will involve testing on KC-135 parabolic flights, the design of flight hardware and testing aboard the Space Shuttle.

Capillary Action↗
PubMed1988

Improved delivery through biological membranes. 26. Design, synthesis, and pharmacological activity of a novel chemical delivery system for beta-adrenergic blocking agents.

Novel ketoxime analogues of known beta-blockers (propranolol, timolol, carteolol) were synthesized and tested as potential site-specific chemical delivery systems. It was assumed that a hydrolysis-reduction sequence could produce the active beta-blockers in the iris-ciliary body. It was found that some of these bioprecursors are remarkably active in reducing intraocular pressure in rabbits. The ketoxime derivative of propranolol is more effective and much less irritant than its parent beta-blocker. While the ketoximes also displayed activity on isoprenaline-induced tachycardia after iv administration, they were void of activity when given orally. Propranolol was found for a prolonged time and in significant concentrations in the rabbit's eye following topical administration of its ketoxime precursor; however, the inactive ketoximes apparently were not converted to the corresponding beta-blockers in the eye. A correlation was found between the physicochemical properties of the ketoximes and their conversion to the amino alcohol and thus their subsequent activity. The results suggest that at least some of the ketoxime precursors could have a use as antiglaucoma agents without systemic side effects.

Adrenergic beta-Antagonists↗