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[Arthrography in the diagnosis and treatment of idiopathic adhesive capsulitis].

The painful shoulder--i.e., adhesive capsulitis--present two basic symptoms: painful and impaired motion. Clinics allow the diagnosis to be made, but treatment is difficult. In our opinion, shoulder arthrography is very useful to distinguish idiopathic from secondary capsulitis involving bones and joints: moreover, in the patients with adhesive capsulitis, arthrography is useful when removing adhesions by repeated forceful distensions of the joint capsule. January 1990 through December 1991, forty-five patients with adhesive capsulitis were studied with shoulder arthrography; 19 patients with primary adhesive capsulitis underwent forceful distension with lidocain and contrast medium and the intraarticular injection of 40 mg of triamcinolone enantate to eliminate local adhesions. Arthrographic brisement yielded good results: improved motion was observed in all patients, lasting 2 to 7 months. Forceful joint capsule distension is easy to perform and complication-free and yields valuable results; all of the above make the procedure advisable as a good alternative to surgery in primary adhesive capsulitis patients.

Arthrography↗

New capsule with tailored properties for the encapsulation of living cells.

A new capsule for the encapsulation and transplantation of pancreatic islets has been developed. Five active ingredients are involved in the capsule formation process: high viscosity sodium alginate (SA-HV), cellulose sulfate (CS), poly(methylene-co-guanidine) hydrochloride (PMCG), calcium chloride, and sodium chloride. Complexation reaction exhibits several unique features: (1) solution of SA-HV with CS represents a physical mixture of two entangled polyanions that provide both pH-sensitive (carboxylic) and permanently charged (sulfate) groups; (2) presence of CaCl2 in the cation solution ensures formation of the gelled bead after the drop of polyanion solution is immersed in the cation solution; (3) character of the polycation (PMCG), i.e., low molecular weight and unusually high charge density, combines both high mobility and reactivity; (4) presence of PMCG in cation solution, together with CaCl2, gives rise to the competitive binding of these two cations based on their diffusion and affinity towards the anion groups; and (5) NaCl provides the anti-gelling sodium ions that significantly affect the reaction of CaCl2 with the polyanion matrix, thus altering the final properties of the capsule surface, shape, and permeability. The capsule size, mechanical strength, membrane thickness, and permeability can be precisely adjusted and quantified. Detailed information on the permeability aspects is given in another paper by Brissová et al. [J. Biomed. Mater. Sci., 39, 61 (1998)]. The new features concerning capsule processing and testing are presented. We believe that the capsule characteristics can be optimized in the next step to meet the biological criteria. The initial transplantation results suggest that this capsule is biocompatible and noncytotoxic and is a promising candidate for the immunoisolation of cells such as pancreatic islets.

Animals↗

Preparation and evaluation of micro-porous ethylcellulose capsule as oral sustained-release preparation of theophylline.

Micro-porous ethylcellulose (EC) membrane capsules were prepared by dissolving polyvinylalcohol (PVA) particles from membranes which were made of a mixture of EC (a water-insoluble polymer). The pore size was approximately 400 microns. Since the dissolution rate of theophylline from the micro-porous EC membrane capsules was fast, gel-forming polymer, poly(acyclic) acid (Carbomer), was incorporated inside the capsule at 10, 20 or 30 mg. Using test capsules containing 100 microns of theophylline, in vitro dissolution studies were performed. By including Carbomer in capsule formulations, the dissolution rate of theophylline was decreased. However, there were not significant differences in dissolution rates between preparations containing the three different amounts of Carbomer. In vivo evaluation studies using beagle dogs showed that AUC, Cmax and Tmax were inversely proportional to the formulated amount of Carbomer. The capsule containing 20 mg of Carbomer gave plasma theophylline concentrations between 5 and 15 micrograms mL-1, which reflect levels within the therapeutic window. The effect of food intake on the pharmacokinetics of theophylline was also studied with the same capsule. Food increased AUC, Cmax and Tmax, although plasma theophylline levels were maintained within the therapeutic range.

Administration, Oral↗

Zeta-potentials of alginate-PLL capsules: a predictive measure for biocompatibility?

Alginate-poly-L-lysine (PLL) microencapsulation of cells is a promising approach to prevent rejection in the absence of immunosuppression. Clinical application, however, is hampered by insufficient insight in factors influencing biocompatibility of the capsules. By now, it has been accepted that not only the chemical composition of the materials applied but also other factors contribute to bioincompatibility. The zeta-potential serves as a measure for the electrical charge of the surface and has been shown to be a predictive value for the interfacial reactions between the biomaterial and the surrounding tissue in other applications. In the present study, we have assessed the streaming potential of alginate-PLL capsules composed of either low-, intermediate-, or high-guluronic (G) alginate to calculate the zeta-potential. The zeta-potentials of the capsules were compared to the biological response against the capsules at 4 weeks after implantation in the rat. We show that high-G and low-G alginates provoke a more severe response in the rat than capsules prepared of intermediate-G alginate. This correlates with a higher zeta-potential of the high-G and low-G alginates and by a change in zeta-potential at lower pH. These lower pH-levels are common directly after implantation as the consequence of a host-response associated with mandatory surgery. Our results suggest that we should not only consider the capsule properties under physiological circumstances to explain bioincompatibility but also the capsule features during common pathophysiological situations.

Alginates↗

Possible changes in secondary structure and composition of human lens capsules in hereditary congenital cataract.

BACKGROUND: Scanty information is available on the changes in conformational structure and composition of human lens capsule in cases of hereditary congenital cataract. The purpose of this study was to use Fourier-transformed infrared (FT-IR) spectroscopy to determine the secondary structure and composition of hereditary cataractous human lens capsule, as compared with normal human lens capsule. METHODS: FT-IR spectroscopy with the Fourier self-deconvolution and curve-fitting program was performed, and second-derivative analysis was used to verify the peak positions and assignments of the IR spectra. RESULTS: The curve-fit FT-IR spectra revealed that the content of hydroxylysine and arginine were clearly higher in the lens capsule of the hereditary congenital patient, but the content of aspartic acid significantly lower, than in normal human lens capsules. The secondary conformational changes in alpha-helix, triple helix and random coil structures were important findings in the lens capsule of a hereditary cataractous patient. CONCLUSION: Possible alterations in secondary structures and compositions of lens capsule are observed in the hereditary congenital cataractous patient by using FT-IR spectroscopy with curve-fitting and second-derivative analysis.

Adult↗

Intrauterine capsules for incubation of gametes and subsequent release of embryos.

In order to obtain incubation in uteri of spermatozoa, oocytes, and embryos, for treatment of patients referred for in vitro fertilization, a capsule was produced which could contain the human gametes and allow human fertilization and embryo growth after intrauterine introduction. Agar was chosen for capsule material and a mold was constructed for the production of capsules. The material was tested in vitro using mouse embryos and human oocytes and sperm. Intrauterine resolution was tested on mice and by insertion on 11 women. Empty capsules were inserted into the uterine cavity in 15 cycles the day after the luteinizing hormone peak and followed by daily ultrasound examinations. The resolution time was adjusted by changing the wall thickness of the capsules. The final type was dissolved after 3 to 4 days. No complications were observed and capsules could be inserted on all occasions. The major problem was expelling of capsules, which occurred in seven cycles. The problem seemed to be solved by the administration of indomethacin at the day of insertion.

Adult↗

Ultrastructure of the anterior lens capsule after vitrectomy with silicone oil injection. Correlation of clinical and morphological features.

To clarify the mechanical difficulties experienced when performing anterior capsulorhexis in vitrectomized eyes filled with silicone oil. Five anterior lens capsules removed from eyes with a silicone oil history were submitted to light and electron microscopic analysis and then compared to two capsules from eyes with trauma history and seven capsules from eyes without silicone oil or trauma history. Comparable abnormalities of the inner and outer surface of the anterior lens capsule were consistently observed after silicone oil fill of the vitreous cavity or after traumatic impact to the lens: patches of multilayer epithelial cells with interspersed capsule material and connective tissue were observed on the posterior surface of the anterior lens capsule. The development of this anterior subcapsular tissue plaque is obviously influenced not only by the PVR process or by side effects of the surgical procedure but also by the silicone oil tamponade or a trauma history. The plaque can be considered primarily responsible for the increased mechanical resistance of the lens capsule in all eyes with silicone oil / trauma history examined in this study.

Cataract Extraction↗

Assessment of a new modified soft jelly capsule containing nonoxynol as spermicide contraceptive.

The mean rupture time, after its vaginal insertion, of a new modified soft jelly capsule containing nonoxynol-9 (DF-486) was investigated in 40 women. The subjects were randomly allocated to 8 study groups. The capsules remained in the vagina from 2-13 minutes. Vaginal infection, vaginal dryness, and multiparity, were recorded. Capsule rupture was not observed at minute 2; 20% of capsules that remained in the vagina 3 minutes suffered rupture, as did 80% of capsules that remained 4, 5 and 7 minutes, and 100% of those remaining 9 minutes or more. The mean rupture time of the studied capsules was 8.2 minutes with 95% confidence limits of 6.2 and 8.8 minutes. At minutes 2-7, vaginal infection, dryness and tone diminution probably accounted for lack of rupture; after minute 7, these factors did not influence capsule rupture.

Administration, Intravaginal↗

Adhesive capsulitis of the shoulder: evaluation with MR arthrography.

The purpose of this study was to determine the usefulness of magnetic resonance (MR) arthrography for diagnosing adhesive capsulitis. Shoulder MR images of 28 patients with (n=14) and without (n=14) adhesive capsulitis were retrospectively analyzed. MR images were assessed for capsule and synovium thickness as well as the width of the axillary recess on oblique coronal fat-suppressed T1-weighted images and T2-weighted images, respectively. On oblique sagittal fat-suppressed T1-weighted images, the width of the rotator interval and the presence of abnormal tissue in the interval were evaluated. Significant differences were found between the two groups in capsule and synovium thickness on both sides of the recess on oblique coronal T2-weighted images (P=0.000), whereas thickness on the humeral aspect showed no significant difference on oblique coronal fat-suppressed T1-weighted images (P=0.109). On oblique coronal T2-weighted images, a cut-off value of 3-mm thickness gave the highest diagnostic accuracy for adhesive capsulitis with sensitivity, specificity, and accuracy of 79% (11/14), 100% (14/14), and 89% (25/28) at the humeral side and 93% (13/14), 86% (12/14), and 89% (25/28) at the glenoid side, respectively. There were significant differences in rotator interval width, presence of abnormal tissue in the rotator interval, and axillary recess width between the two groups (P<0.05). Thickness of capsule and synovium of the axillary recess greater than 3 mm is a practical MR criterion for diagnosing adhesive capsulitis when measured on oblique coronal T2-weighted MR arthrography images without fat suppression. The presence of abnormal tissue in the rotator interval showed high sensitivity but rather low specificity.

Adult↗

Innervation and functional characteristics of connective tissues, especially elastic fibers, in human fetal thoracic intervertebral articular capsule and its surroundings.

The articular capsules between the thoracic vertebrae, which have physiologically different functions from those of other levels of the vertebrae, have yet to be subjected to neuro-anatomical and fine structural analysis. In the present study, we analyzed serial frozen sections of decalcified thoracic vertebrae in human fetuses, and identified the articular capsule tissue with its unique distribution of elastic fibers. The fine structure of the elastic fibers was studied by transmission electron microscopy. In the early-stage fetus, the fibrous membrane forming the lateral intervertebral articular capsule contained abundant thin elastic fibers consisting of microfibrils. In the late-stage fetus, the lateral capsule of fibrous membrane was occupied by thick elastic fibers. A medial articular capsule, namely the ligamenta flava, contained numerous thick elastic fibers in both early and late-stage fetuses. The distributional differences in nerve fibers between early and late-stage fetuses were determined by immunostaining, using antibodies raised against protein gene product 9.5 (PGP 9.5; ubiquitin carboxyl-terminal hydrolase). Innervation by PGP 9.5 immunoreactive fibers was limited to the areas of the articular capsules near the blood vessels, which may indicate their functional relation with blood flow. No PGP 9.5 immunoreactive fibers were found in the ligamenta flava of the late-stage fetus. Innervation might be directly involved in the development of the intervertebral articular capsules in normal human fetuses.

Antibodies↗

Bioavailability of phenylalanine and aspartate from aspartame (20 mg/kg) in capsules and solution.

Aspartame (L-aspartyl-L-phenylalanine methyl ester) was given in capsules or solution to compare the bioavailability of its constituent amino acids, aspartate and phenylalanine. Twenty healthy subjects received a single 20 mg/kg dose of aspartame in capsules or solution in a randomized, crossover design. Plasma amino acid concentrations and the phenylalanine to large neutral amino acid ratios (Phe/LNAA) were determined. Plasma aspartate concentrations did not increase with either treatment. For plasma phenylalanine following capsule ingestion, there was a smaller peak plasma concentration (Cmax; 103.3 v 126.6 mumol/L), a longer time to peak concentration (tmax; 108.6 v 36.6 minutes), but no significant difference in the area under the plasma concentration-time curve (AUC) (7,656 v 7,200 mumol.min/L) when compared with solution ingestion. The maximum plasma Phe/LNAA ratio was smaller (0.16 v 0.19) with capsules. The changes for plasma tyrosine were similar to those seen with phenylalanine. There were no significant differences in the plasma concentrations of the other LNAAs between capsule and solution ingestion. Thus, given the small effect on phenylalanine Cmax and Phe/LNAA and no effect on the extent of absorption of phenylalanine, aspartame ingested in capsules at doses up to 20 mg/kg is a suitable dosage form for blinded clinical studies, provided that the slower rate of absorption of phenylalanine from capsules is taken into account.

Adolescent↗

Capsule endoscopy findings in patients with suspected Crohn's disease and biochemical markers of inflammation.

BACKGROUND: Because it provides a direct view of superficial lesions in the small bowel, capsule endoscopy is a promising diagnostic tool for studying patients with suspected Crohn's disease undetected by conventional modalities. AIM: To assess the role of capsule endoscopy in the diagnosis of patients with suspected Crohn's disease. PATIENTS AND METHODS: Thirty-eight patients (16 males, mean age 46.2 years) with suspected Crohn's disease but negative at conventional imaging were examined using capsule endoscopy. They were divided into 2 groups: 12 patients with ongoing symptoms (Group 1), and 26 with ongoing symptoms and biochemical markers of inflammation (Group 2). Capsule endoscopy findings were classified as diagnostic (multiple erosions/ulcerations), suspicious (<or=3 erosions/ulcerations), non-specific and normal. RESULTS: Capsule endoscopy findings were diagnostic for Crohn's disease in 13 (34.2%) patients, suspicious in 2 (5.3%), non-specific in 4 (10.5%) and normal in 19 (50%), with an overall detection rate of 39.5%. The yield of positive findings was 8.3% in Group 1 and 46.2% in Group 2 (p=0.022). Capsule endoscopy findings prompted specific measures or patient management changes in 39.5% of patients. CONCLUSIONS: Capsule endoscopy has a high diagnostic yield in patients with suspected Crohn's disease and both clinical and biochemical markers of inflammation.

Adolescent↗

The capsule plays an important role in Escherichia coli K1 interactions with Acanthamoeba.

Escherichia coli K1 is shown to bind to, associate with, invade and survive inside Acanthamoeba, but the precise mechanisms associated with these events are unclear. We have previously shown that outer membrane protein A and lipopolysaccharide are critical bacterial determinants involved in E. coli K1 interactions with Acanthamoeba. Using an isogenic K1 capsule-deletion mutant (lacking the neuDB genes cluster that is necessary for the production of cytoplasmic precursors to the exopolysaccharide capsule), we observed that the capsule modulates and enhances E. coli K1 association and survival inside Acanthamoeba. The capsule-deletion mutant exhibited significantly reduced association compared with the wild type strain, E44. Similarly, the K1 capsule-deletion mutant exhibited limited ability for invasion/uptake by and survival inside Acanthamoeba. Next, we determined whether E. coli K1 survive inside Acanthamoeba during the encystment process and that viable bacteria can be isolated from the mature cysts. Using encystment assays, our findings revealed that E. coli K1, but not its capsule-deletion mutant, exhibit survival inside Acanthamoeba cysts. We believe this is the first demonstration that the K1 capsule plays an important role in E. coli K1 interactions with Acanthamoeba.

Acanthamoeba↗

Use of texture analysis to study hydrophilic solvent effects on the mechanical properties of hard gelatin capsules.

The aim of this work was to explore texture analysis for quantitative evaluation of the effect of hydrophilic solvent systems used as capsule fills on the mechanical properties of hard gelatin capsules. For this purpose, a texture analyzer (Stable Micro Systems, model TA.XT Plus) equipped with a capsule separating rod fixture was used. The tests were conducted in a tension mode. Elastic stiffness, tensile force and elongation at break were determined from the experimental stress-strain curve in order to quantitatively describe both brittleness and softening of capsules. In this paper, it has been demonstrated that the effect of various hydrophilic solvent (i.e. propylene glycol (PG), polyethylene glycol 400 (PEG 400), ethanol) mixtures on the mechanical properties of hard gelatin capsules can be easily monitored using texture analysis. Significant counteractive effects between PG and PEG 400 or ethanol on the integrity of capsule shells were discovered in this study. Texture analysis is found to be a convenient tool for studying formulation compatibility. It can be invaluable in early screening studies of liquid filled hard gelatin capsules.

Capsules↗

Near infrared spectroscopy and process analytical technology to master the process of busulfan paediatric capsules in a university hospital.

The prescription of unlicensed oral medicines in paediatrics leads the hospital pharmacists to compound hard capsules, such as busulfan, an alkylating agent prescribed in preparative regimens for bone marrow transplantation. In this study, we have investigated how the general principle of process analytical technology (PAT) can be implemented at the small size of our hospital pharmacy manufacturing unit. Near infrared spectroscopy (NIRS) was calibrated for raw material identification, blend uniformity analysis and final content uniformity of busulfan hard capsules of 11 different strengths. Measurements were performed on capsules from 2 to 40 mg (n=440). After optimisation, accuracy and linearity of the NIRS quantitative method was demonstrated after comparison with a previously validated quantitative high performance thin layer chromatography (HPTLC) method. Such a comparison led to attractive NIRS precision: +/-0.7 to +/-1.0 mg for capsules from 2 to 40 mg, respectively. As NIRS is a rapid and non-destructive technique, the individual control of a whole batch of busulfan paediatric capsules intended to be administrated is possible. Actually, mastering the process of busulfan paediatric capsules with the NIRS integrated into the notion of PAT is a powerful analytical tool to assess the process quality and to perform content uniformity of at least 5mg busulfan-containing capsules.

Alkylating Agents↗

Intraocular lens factors that may affect anterior capsule contraction.

PURPOSE: To examine the various factors comprising intraocular lenses (IOLs) that may affect the degree of anterior capsule contraction after cataract surgery. DESIGN: Randomized controlled clinical trials. PARTICIPANTS: Three hundred thirty-one patients scheduled for bilateral cataract surgery were studied to compare the degree of anterior capsule contraction in fellow eyes that received different IOLs with regard to the following factors: (1) optic material-acrylic optic versus silicone optic; (2) optic design-round-edge optic versus sharp-edge optic; (3) haptic material-polymethyl methacrylate (PMMA) loop versus polyvinylidene fluoride loop; and (4) haptic material and design-single-piece acrylic haptic versus 3-piece PMMA haptic. The 2 IOLs implanted in the fellow eyes of each patient had almost the same material and design, except for the specific factor being compared. METHODS: All patients underwent phacoemulsification surgery with implantation of different IOLs in fellow eyes. MAIN OUTCOME MEASURES: The area of the anterior capsule opening was measured using the Scheimpflug videophotography system at 3 days or 1 week (baseline) and at 1, 3, and 6 months after surgery. The percent reduction in the anterior capsule opening area from baseline was determined at 1, 3, and 6 months after surgery. RESULTS: The mean percent reduction of the anterior capsule opening area was significantly greater in eyes with a silicone optic IOL than in eyes with an acrylic optic IOL. However, no significant difference was observed in the percent reduction between round-edge and sharp-edge optic IOLs, between PMMA and polyvinylidene fluoride loop IOLs, and between single-piece acrylic and 3-piece PMMA haptic IOLs. Strong associations were found in the percentage between round-edge and sharp-edge optic IOLs, between PMMA and polyvinylidene fluoride loop IOLs, and between single-piece acrylic and 3-piece PMMA haptic IOLs, whereas there was a relatively weak association between silicone and acrylic optic IOLs. CONCLUSIONS: Among the IOL factors examined, optic material affects most significantly the degree of anterior capsule contraction, whereas optic design and haptic material and design are not strongly related to anterior capsule contraction.

Acrylic Resins↗

Reduction in the area of the anterior capsule opening after polymethylmethacrylate, silicone, and soft acrylic intraocular lens implantation.

PURPOSE: To report reduction in the area of anterior capsule opening at various postoperative intervals after continuous capsulorrhexis and to compare any differences in the area reduction between polymethylmethacrylate, silicone, and soft acrylic intraocular lenses. METHODS: Prospectively, 240 eyes of 240 patients undergoing phacoemulsification and intraocular lens implant surgery were randomized into three groups based on the type of intraocular lens used: polymethylmethacrylate, silicone, and soft acrylic. The area of the anterior capsule opening was quantitated, and examinations were performed at 1 week and 1, 3, and 6 months postoperatively. RESULTS: After intraocular lens implantation, the mean anterior capsule opening area 3 months postoperatively was significantly smaller than that at 1 week in all groups (polymethylmethacrylate, P = .0090; silicone, P < .0001; soft acrylic, P = .0127). Mean percentages in area reduction at both 3 and 6 months postoperatively were significantly greater than those at 1 week and 1 month (P < .0001). In comparing the three intraocular lenses at 1 week postoperatively, no statistical significance was observed regarding the anterior capsule opening area between the three groups. However, the mean anterior capsule opening areas in the polymethylmethacrylate and soft acrylic intraocular lens groups were significantly larger than those in the silicone intraocular lens group at 1 month (P = .0024), and 3 months (P = .0032), and 6 months (P = .0022) postoperatively. CONCLUSIONS: After continuous capsulorrhexis and intraocular lens implant surgery, the area of the anterior capsule opening gradually decreased for up to 3 months postoperatively. The contraction of the anterior capsule opening was greater in the silicone group than in either the polymethylmethacrylate or the soft acrylic groups.

Acrylates↗

Ultrastructural fragility and type IV collagen abnormality of the anterior lens capsules in a patient with Alport syndrome.

PURPOSE: To investigate ultrastructural and immunohistological abnormalities of the lens capsules in a patient with Alport syndrome. METHODS: Two anterior lens capsules were obtained at phacoemulsification from a 43-year-old female patient with bilateral lenticonus who was affected by Alport syndrome. The right capsule was examined by transmission electron microscopy and the left capsule was stained with two monoclonal antibodies against the triple-helical domains of type IV collagen alpha2 and alpha5 chains. RESULTS: Numerous vertical dehiscences with many disrupted interdigitations were observed in the right anterior lens capsule. Decreased reactivity of monoclonal antibodies against type IV collagen alpha5 chain and normal reactivity against the alpha2 chain were shown in the left anterior lens capsule. CONCLUSION: The ultrastructural fragility of the anterior lens capsules in this patient with Alport syndrome appears to be associated with the abnormality of the type IV collagen molecules including the alpha5 chain.

Adult↗