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PubMed1995

Expression of capsules by Haemophilus influenzae in mixed infections.

The pathogenicity of eight clinical isolates of non-type b Haemophilus influenzae was investigated by inoculating them subcutaneously into mice, alone or mixed with viable or non-viable bacteria of certain other species. Three of the H. influenzae isolates were non-capsulated while five were slightly capsulated (less than 1% of organisms had capsules). The other strains of bacteria tested were four isolates of capsulated and four isolates of non-capsulated pigmented strains of Prevotella sp. and Porphyromonus sp. as well as a capsulate Klebsiella pneumoniae ("helpers"). None of the non-capsulated strains induced an abscess when inoculated alone. Following co-inoculation of viable or non-viable "helpers" with H. influenzae, abscesses were formed in all instances in which the "helper" had a capsule. Profusely capsulated cells of H. influenzae were recovered, however, only from abscesses induced with the five slightly capsulated strains of H. influenzae. These capsulated organisms were found serologically to be of type b and induced abscesses when inoculated alone. Our findings illustrate the ability of non-capsulated strains of H. influenzae to produce progeny of capsulated type b organisms after co-inoculation with certain other species.

Abscess↗

PubMed2001

Factors affecting capsule size and production by lactic acid bacteria used as dairy starter cultures.

The effects of sugar substrates on capsule size and production by some capsule-forming nonropy and ropy dairy starter cultures were studied. Test sugars (glucose, lactose, galactose, or sucrose) were used as a sole carbohydrate source and the presence of a capsule and its size were determined by using confocal scanning laser microscopy. Nonropy strains produced maximum capsule size when grown in milk. Strains that did not produce capsules in milk did not produce them in any other growth medium. Specific sugars required for capsule production were strain-dependent. Increasing lactose content of Elliker broth from 0.5 to 5% or adding whey protein or casein digest produced larger capsules. Whey protein concentrate stimulated production of larger capsules than did casamino acids or casitone. Some Streptococcus thermophilus strains produced capsules when grown on galactose only. Nonropy strains of Lactobacillus delbrueckii subsp. bulgaricus produced capsules on lactose, but not on glucose. A ropy strain of Lactobacillus delbrueckii subsp. bulgaricus produced a constant capsule size regardless of the growth medium. The ability of some strains of Streptococcus thermophilus to use galactose in capsule production could reduce browning of mozzarella cheese during baking by removing a source of reducing sugar. Media that do not support capsule production may improve cell harvesting.

Animals↗

PubMed1993

The dissolution and bioavailability of etodolac from capsules exposed to conditions of high relative humidity and temperatures.

The dissolution and bioavailability of etodolac from capsules exposed to high relative humidity and temperature were compared to those from capsules stored at room temperature (RT). Dissolution of stressed and control capsules was evaluated using a USP basket apparatus at 100 rpm with 900 mL pH 7.5 phosphate buffer (0.05 M) at 37 degrees C. The dissolution of etodolac from capsules exposed to stressed conditions was also evaluated with enzymes (pancreatin, 1%, w/v) added to the dissolution medium. The bioavailability of etodolac from capsules exposed to stressed conditions was compared in both dogs and humans to capsules stored at RT conditions. Capsules, 200 and 300 mg, exposed to stressed conditions failed the dissolution (without enzymes) specification [not less than 85% released (80% Q) in 30 min]. However, upon enzyme addition, all capsules met the specification. The rate and extent of absorption from these 200 and 300 mg etodolac capsules in dogs were equivalent to those from capsules stored at RT conditions that passed the dissolution specification. Similarly, the bioavailability of etodolac from 300 mg capsules that failed the dissolution specification upon exposure to stressed conditions was equivalent to that of control capsules in 24 adult male volunteers. Thus, an in vitro dissolution test with enzymes provides a better indication of stressed capsule performance in vivo.

Animals↗

PubMed2005

Does passage of a patency capsule indicate small-bowel patency? A prospective clinical trial?

BACKGROUND AND STUDY AIMS: At many centers wireless capsule endoscopy (WCE) without prior radiographic examination to rule out relevant strictures is considered to be contraindicated in suspected obstructive small-bowel disease. However, the accuracy of radiography in this situation has often been questioned. The purpose of this prospective study was to investigate the feasibility and safety of the recently developed patency capsule, and its predictive value regarding the clinical relevance of radiographic small-bowel strictures. PATIENTS AND METHODS: 22 patients with suspected obstructive small-bowel disease and/or radiological evidence of small-bowel strictures underwent a patency capsule examination. Intact passage, patient experience of pain, and capsule disintegration were correlated with radiographic findings, clinical variables, and outcome. RESULTS: 13 patients passed an intact capsule without complaints, despite radiographically observed small-bowel stenosis; the subsequent video capsule examination was uneventful in all. In nine patients either intact passage was painful or the capsule disintegrated; in one of these, impaction of an intact capsule led to an ileus and emergency surgery. The type of capsule passage did not correlate with radiographic presence of a stricture, underlying diagnosis, or previous surgery. There was a statistically significant correlation between outcome (surgery performed or recommended) and occurrence of painful capsule passage and disintegration ( P < or = 0.05). CONCLUSIONS: Painless egestion of an intact patency capsule indicates safety of WCE. Patients without obstructive symptoms require neither small-bowel radiography nor a patency capsule study prior to WCE. Disintegration of the patency capsule or painful passage seems to be associated with a clinically relevant small-bowel stricture and with a high probability of surgery.

Adult↗

PubMedDate not supplied

Time domain 1H NMR as a new method to monitor softening of gelatin and HPMC capsule shells.

Defined mechanical properties are an essential requirement for any pharmaceutical dosage form and this is particularly important in the case of liquid-filled capsules. Changes in the mechanical properties may be induced by exposure of the capsules to humidity or by a shift of the water equilibrium that typically occurs when hydrophilic or amphiphilic fill masses are used, for example, in self-emulsifying drug delivery systems. This study aims to characterize the softening of empty hard gelatin and hydroxypropyl methylcellulose (HPMC) capsules by means of mechanical tests, a Bareiss hardness test, and a stiffness test using a texture analysis method. A benchtop time domain NMR method is applied in addition to characterize the physico-chemical state of water in the capsule shells and to correlate this with the results of the mechanical tests. Hardness and stiffness measurements resulted in corresponding values, showing a softening for both capsule materials in a humid environment, which was most pronounced beyond 60% relative humidity. The capsules made of gelatin exhibited in general higher stiffness and hardness values compared to the HPMC capsules. The physico-chemical state of water in the capsule shells, as probed by a time domain NMR method, was interpreted in terms of a population balance model. Three different water populations were identified that differ in their molecular mobility, as indicated by their characteristic spin-lattice relaxation times, T1. The most loosely bound water fraction dominated in the capsule shells in the range beyond 60% relative humidity. Numerical correlation of the data led to a heuristic equation between the NMR-derived fraction of loosely bound water in the capsule shells and their mechanical stiffness and hardness. Adequate models were obtained for both capsule types, gelatin, and HPMC. Mechanical measurements of pharmaceutical capsules are generally destructive and time consuming. Testing is usually performed in an analytical laboratory, off-line from the manufacturing process, and involves only a small number of samples. Based on the here presented correlation between mechanical stiffness measurements and benchtop time domain NMR data, the latter method may be used as a nondestructive alternative for mechanical testing. This study also opens the possibility to investigate liquid-filled capsules and to establish a process analytical technology (PAT) during manufacturing.

Capsules↗

PubMed2003

The effect of capsule composition in the reversal of hyperglycemia in diabetic mice transplanted with microencapsulated allogeneic islets.

The transplantation of microencapsulated islets may allow reversal of hyperglycemia in the absence of immunosuppression. Poly-L-lysine (PLL) on capsules may potentiate the fibrotic reaction against implanted capsules. The aims of this study were to investigate how the biocompatibility of such capsules affects their function in vivo and to compare their efficacy relative to naked islets after intraperitoneal transplantation to nude or immune competent mice. Alloxan-diabetic C57BL/6 wild-type or nude (nu/nu) mice were transplanted with naked BALB/c islets, empty capsules, or microencapsulated BALB/c islets. Three types of capsules were used, one containing a high guluronic acid (G) alginate and PLL, one with a high mannuronic acid (M) alginate and PLL, and one high M alginate capsule with no PLL. Hyperglycemia in nude mice was reversed after transplantation of naked islets or islets encapsulated in a capsule containing high M alginate. Nude mice transplanted with islets encapsulated in the high G capsules showed only a transient reversal of hyperglycemia. In an allogeneic system, naked BALB/c islets were rejected by day 10 after transplantation, whereas the islets encapsulated in high M capsules continued to function for at least a month. When PLL was excluded from the capsules, the grafts functioned for up to 8 weeks. Islets microencapsulated in high G alginate capsules fail to reverse hyperglycemia for more than a few days in nude mice. However, islets in high M alginate capsules can reverse hyperglycemia in nude and immune competent mice. Islets microencapsulated in PLL-free high M alginate capsules function for 8 weeks in immune competent mice.

Alginates↗

PubMed2002

The vascular anatomy of the glenohumeral capsule and ligaments: an anatomic study.

BACKGROUND: A detailed description of the vascular anatomy of the shoulder capsule is lacking, yet surgical procedures may put this capsular blood supply at risk. We hypothesized that a hypovascular area is present in the capsule. The purpose of the present study was to describe the vascular anatomy of the human glenohumeral capsule and ligaments and its relevance to surgical treatment of the shoulder. METHODS: In twenty-four fresh adult cadaveric shoulders, the axillary artery proximal to the thoracoacromial branch and the suprascapular artery were injected with India ink. The specimens were sectioned and then cleared with a modified Spalteholz technique. RESULTS: The glenohumeral capsule demonstrates consistent arterial contributions from the anterior circumflex, posterior circumflex, circumflex scapular, and suprascapular arteries. The arterial supply is centripetal in nature. The contributing vessels enter the capsule both laterally and medially and arborize toward the middle of the capsule. The rotator cuff provides additional blood supply to the capsule through perforating vessels. The dominant capsular vessels run horizontally and form intracapsular anastomoses via vertical branches. The anterior and posterior bands of the inferior glenohumeral ligament complex are vascularized by adjacent parallel vessels. In five of twelve specimens, a hypovascular zone was located near the humeral insertion of the anterior aspect of the capsule. In these five specimens, there was an associated hypovascular zone in the underlying capsule. CONCLUSION: The glenohumeral capsule is a well-vascularized structure with direct predictable contributions from four named arteries. These arteries send branches that enter the capsule superficially and from the periphery. These dominant vessels run horizontally toward the midcapsule and to deeper layers of the capsule. Vessels originating from the rotator cuff provide additional blood supply to the capsule.

Adult↗

PubMed1989

A morphometric analysis of the development of the rat lens capsule.

This study analysed patterns of growth of the lens capsule by measuring capsule thickness at 13, 16 and 19 days of embryonic development and 2, 21, 140 and 600 days of post-natal development. The major findings were that, at early stages of embryonic development, the posterior capsule was thicker than the anterior capsule. However, at later stages, the posterior capsule did not increase in thickness whereas the anterior capsule continued to thicken so that, by 2 days of post-natal development, the situation was reversed and the anterior capsule was significantly thicker than the posterior capsule. This trend continued and by 600 days post-natal development, the anterior capsule was 7.5 times thicker than the posterior capsule. In these older lenses the capsule tapered sharply in thickness from the anterior to the posterior equatorial region. These regional differences in thickness of the lens capsule, and the changes reported during development, may reflect changes in capsule production by epithelial and fibre cells as they differentiate.

Animals↗

PubMed1988

An improved pressure-sensitive capsule for endoscopic measurement of esophageal variceal pressure.

A new small noninvasive pressure-sensitive capsule for the endoscopic measurement of esophageal varix pressure was evaluated and compared to an initial Yale-designed capsule to test the hypothesis that the diameter of the capsule measuring surface is a limiting factor for the accuracy and variability of capsule pressure measurements. Capsule pressures obtained with each capsule, using rabbit mesenteric vessels comparable in size to human esophageal varices, were correlated with direct intraluminal pressure measurements. There was an excellent correlation between capsule pressure measurements obtained with the small capsule and intraluminal pressure (r2 = 0.97) which was significantly greater than the correlation obtained when the initial capsule was studied (r2 = 0.89, P less than 0.01). The variability of capsule pressure measurements obtained with the small capsule was less than that observed when measurements were obtained with the initial capsule (P less than 0.01). Therefore, this new small capsule should provide the most accurate and reproducible noninvasive measurements of variceal pressure.

Animals↗

PubMed1969

Elastic constants of the human lens capsule.

1. A technique is described whereby the elasticity of the human lens capsule has been determined at birth and throughout life. This technique requires three separate determinations: (a) thickness; (b) stress and strain; (c) Poisson's ratio; (a) the capsule was clamped between accurately perforated ground glass plates and its thickness determined by noting the change in depth of focus between Latex spherules adhering to its upper and lower surfaces; (b) the undisturbed capsule was then placed in a specially designed glass distension apparatus and the relationship between volume and pressure recorded when it was distended with isotonic saline. The permeability of the capsule was also measured; (c) in some cases Poisson's ratio was determined by measuring the change of thickness of the capsule and the height to which it rose when distended with isotonic saline at different pressures. An apparatus was designed for this purpose.2. The average thickness of the anterior capsule increases from birth until about the 60th year but thereafter it decreases slightly.3. Poisson's ratio was about 0.47 for both cat and human capsule, and no significant variations with age in human capsule could be detected.4. Corrected volume pressure curves obeyed Hook's law almost to the point of capsule rupture.5. In childhood Young's Modulus of elasticity is about 6 x 10(7) dyn/cm(2) and decreases to 3 x 10(7) dyn/cm(2) at 60 and 1.5 x 10(7) dyn/cm(2) in extreme old age.6. The ultimate tensile stress was 2.3 x 10(7) dyn/cm(2) in young capsules and 0.7 x 10(7) dyn/cm(2) in old ones. The maximum percentage elongation was 29 per cent and independent of age.7. The implications of these findings are discussed in relation to(a) the mechanical properties of the lens capsule;(b) the ageing of the lens capsule and basement membranes; and(c) the decrease in elasticity of the lens capsule as a cause of presbyopia.

Aging↗

PubMed1965

Structure and composition of the Bacillus anthracis capsule.

Avakyan, A. A. (Academy of Medical Sciences, Moscow, USSR), L. N. Katz, K. N. Levina, and I. B. Pavlova. Structure and composition of the Bacillus anthracis capsule. J. Bacteriol. 90:1082-1095. 1965.-Observations by various methods of light microscopy (phase contrast, dark-field, and fluorescence) revealed the complex structure of the Bacillus anthracis capsule, which changes regularly during the growth cycle of the culture. Special cytological methods of staining the capsule made it possible to study its fine structure, which is not revealed by negative staining with India ink. For example, the capsule shows a membranelike outline, fine transverse lines, and interruptions and transverse septa traversing the entire capsule. By using cytochemical methods, it was found that the capsule has a stratified structure and that the various layers of the capsule differ as to the value of the isoelectric point, metachromatic ability, sensitivity to various enzymes, and, consequently, chemical composition. It was thus shown that the membranelike outline of the capsule consists of peptides and neutral mucopolysaccharides. The middle part of the capsule consists of a complex of substances of both polysaccharide and protein nature, and the inner part consists of acid mucopolysaccharides. Observation of the capsular forms of B. anthracis by means of an electron microscope revealed differences in the osmiophilia and submicroscopic structure of the membranelike outline and the middle and inner parts of the capsule. Immunochemical studies conducted by the fluorescent-antibody method revealed localization of antigens in different parts of the capsule, and made it possible to differentiate the capsular antigens according to their serum-staining ability and according of their relations to enzymes, i.e., their chemical composition. This paper concerns the possibility of studying the fine structure of bacterial capsules in fixed preparations, and the differences and similarities of the antigens of the capsule and cell wall of B. anthracis and of the related species, B. megaterium.

Bacillus anthracis↗

PubMed1976

Free amino acids in the normal and cataractous bovine and human lens capsule and lens.

With circular chromatography on paper, we have tested the content of the free amino acids in the normal and cataractous bovine and human lens capsule and lens. The interpretation of the data shows that the normal bovine lens without capsule presents a greater quantity of free amino acids in relation to the bovine cataractous lens without capsule; the lens capsule of normal bovine lens presents a lesser quantity of free amino acids in relation to the lens capsule of the bovine cataractous lens; the normal human lens without capsule presents a relative increase in quantity of free amino acids in relation to the cataractous human lens without capsule (cortical and nuclear cataract); the lens capsule of the normal human lens presents a decrease in the quantity of free amino acids in relation to the lens capsule of the cataractous human lens (cortical and nuclear cataract); the human cataractous lens in "cataracta nigra" presents a marked decrease in quantity of free amino acids in relation to cataractous human lens without capsule (nuclear and cortical cataract), while the lens capsule of "cataracta nigra", presents a marked increase in quantity of free amino acids in relation to the normal human lens capsule, and decrease in relation to the lens capsule of the cataractous human lens (cortical and nuclear cataract).

Amino Acids↗

PubMed2004

[Formation mechanisms of the fibrous capsule around hepatic and splenic hydatid cyst].

OBJECTIVE: To investigate the formative mechanisms of the fibrous capsule around hepatic and splenic hydatid cyst. METHODS: HE stain was used to observe the histopathologic changes of the fibrous capsules around hepatic and splenic hydatid cysts and the adjacent parenchyma. The expression of collagen IV, fibronectin (FN), laminin (LN), transforming growth factor-beta1 (TGF-beta1) and tumor necrosis factor-alpha (TNF-alpha) were detected by using immunohistochemistry or in situ hybridization in fibrous capsules around 40 hepatic hydatid cysts and 15 splenic hydatid cysts including adjacent parenchyma. RESULTS: A special delaminated phenomenon was observed in the fibrous capsules around hepatic hydatid cysts. Granuloma-like pathologic changes were found in the fibrous capsules near worm and there were many depressed Glisson capsules and hepatic vein system in the fibrous capsules near hepatic parenchyma while these phenomena could not be observed in splenic hydatid cysts. All parameters were highly expressed in the fibrous capsules near hepatic parenchyma and the difference between the two fibrous capsules was significant (P<0.01). CONCLUSION: The mechanisms of forming fibrous capsule around hepatic and splenic hydatid cysts are different. The fibrous capsule around hepatic hydatid cyst is a granuloma-like structure, covered by the pressed Glisson system and hepatic vein system with a small gap between them; while the fibrous capsule around splenic hydatid cyst is formed by granuloma-like tissue covering the worm and there is no gap between the capsule and the splenicparenchyma.

Echinococcosis↗

PubMed2005

Modified conventional hard gelatin capsules as fast disintegrating dosage form in the oral cavity.

Fast disintegrating capsules for administration in the oral cavity were prepared either by perforation or by vacuum-drying of conventional hard capsules. When compared to other fast disintegrating dosage forms (e.g. lyophilized sponges or tablets), these capsules have various advantages, in particular, a high drug loading capacity and no compression steps. The disintegration time of conventional hard gelatin capsules (HGC) was reduced from 91 to 39 s by introducing 6-10 small holes (diameter =25-50 microm) into the capsule shell. Vacuum-drying of conventional hard gelatin capsules resulted in brittle capsules, which broke rapidly in the oral cavity. The brittleness of the hard gelatin capsules correlated well with their moisture content. The critical moisture value for sufficient brittleness of hard gelatin capsules was <4% w/w. In contrast, HPMC capsules remained flexible, even at low moisture content. The moisture uptake of various capsule fillers was in the order of Avicel PH101 > lactose > Avicel PH112 > or = mannitol. Hard gelatin capsules filled with mannitol and packaged in bottles with silica gel kept their desired brittleness during 6 months storage at various relative humidities.

Administration, Oral↗

PubMed2006

Fate of anterior capsule tears during cataract surgery.

PURPOSE: To determine the incidence of anterior capsule tears, at what stage of surgery they occurred, and their intraoperative behavior. SETTING: Ambulatory surgery center, Cincinnati Eye Institute, Cincinnati, Ohio, USA. METHODS: This 5-year retrospective study was of patients having phacoemulsification with posterior chamber intraocular lens (IOL) implantation complicated by unplanned peripheral extension of the capsulorhexis tear or a radial anterior capsule tear. The operative notes and a videotape of the surgery were reviewed. The stage at which the tear was initially observed and when it extended were identified, as was whether the tear extended to the posterior capsule. Anterior vitrectomy and the design and location of the IOL implanted were also analyzed. RESULTS: A discontinuous anterior capsulorhexis or a break in the anterior capsule rim was observed in 21 eyes of 2646 cases, for an overall incidence of 0.79%. Anterior capsule tears were identified during ophthalmic viscosurgical device injection in 1 eye, capsulorhexis in 13 eyes, hydrodissection in 2 eyes, phacoemulsification in 3 eyes, irrigation/aspiration (I/A) in 1 eye, and implantation of a prosthetic iris device in 1 eye. Seven of the 13 tears identified during the capsulorhexis were managed by redirecting the second edge of the "safety" capsulorhexis to incorporate the tear. In 14 eyes, the tear in the anterior capsule extended into the zonules; 4 of these tears were limited. Ten tears extended around the equator and through the posterior capsule, occurring during the hydrodissection in 1 eye, phacoemulsification in 2 eyes, I/A in 1 eye, and IOL implantation in 6 eyes. An anterior vitrectomy was required in 4 eyes that had posterior capsule involvement. Endocapsular fixation of a 1-piece acrylic IOL was achieved in 18 eyes. Three eyes required implantation of a 3-piece acrylic IOL in the ciliary sulcus. CONCLUSIONS: Extension of an anterior capsule tear can complicate cataract surgery at any stage. Extension of the tear through the posterior capsule occurred in almost half the eyes with an anterior capsule tear, often requiring an anterior vitrectomy. Managing an anterior capsule tear can be challenging yet compatible with implantation of a posterior chamber IOL.

Capsulorhexis↗

PubMed2006

After-cataract evaluation after using balanced salt solution, distilled deionized water, and 5-fluorouracil with a sealed-capsule irrigation device in the eyes of 4-week-old rabbits.

PURPOSE: To evaluate the Perfect Capsule sealed-capsule irrigation device (Milvella Pty., Ltd.) using 3 substances in young rabbit eyes. SETTING: St. Erik's Eye Hospital, Stockholm, Sweden. METHODS: Thirty 4-week-old rabbits had clear lens extraction in both eyes. In 1 randomly selected eye, the Perfect Capsule was applied and the lens capsule was irrigated for 5 minutes with 1 of 3 substances: balanced salt solution (BSS), distilled deionized water (DDW), or 5-fluorouracil (5-FU) 50 mg/mL. In the other eye, no sealed capsule irrigation was used. Forty days postoperatively, the animals were killed and the eyes fixed in formalin for histologic analysis. After-cataract was evaluated in 3 ways: clinically, from photographs, and histologically. Central posterior capsule thickness was evaluated using a microscope, camera, and computer. RESULTS: The Perfect Capsule sealed-capsule irrigation system could be used in all selected eyes. The vacuum to the anterior capsule was tight, and the system was sealed in all eyes. After-cataract developed in the BSS group and DDW group, but not in the 5-FU group. The 5-FU group had significantly less after-cataract than the other 2 groups (P<.05). There was no difference between the groups in capsule thickness. CONCLUSIONS: The Perfect Capsule sealed-capsule irrigation system could be used in small eyes. Distilled deionized water did not prevent after-cataract in rabbit eyes with highly proliferative cells, but 5-FU was effective in preventing after-cataract.

Acetates↗

PubMed2005

Wireless capsule endoscopy for obscure small-bowel disorders: final results of the first pediatric controlled trial.

BACKGROUND AND AIMS: Obscure small-bowel disorders are jejunal and ileal lesions undiagnosed by traditional imaging techniques (endoscopic, radiologic). We evaluated the diagnostic usefulness and safety of capsule endoscopy for obscure small-bowel disorders in children and adolescents. METHODS: Comparative, prospective, self-controlled trials in patients (age, 10-18 y) suspected to have either small-bowel Crohn's disease, polyps, or obscure gastrointestinal (GI) bleeding. Capsule results were compared with the diagnostic imaging studies normally used in this age group. RESULTS: Among 20 patients suspected of Crohn's disease, multiple lesions consistent with this diagnosis were observed by capsule endoscopy in 50%. Small-bowel Crohn's disease was ruled out in 8 patients. Eosinophilic enteropathy was found in 2 others. For polyp detection (n = 6), capsule endoscopy yielded 100% concordance with the control studies when analyzed per patient. However, capsule endoscopy revealed a greater number (50%) of polyps. Among patients with obscure bleeding (n = 4), the capsule examination confirmed a diagnosis of vascular malformations in 3. Capsule endoscopy more accurately identified the precise source of bleeding compared with angiography. All 30 capsule studies were well tolerated, although 1 capsule was retained owing to an inflammatory stenosis. The capsule eventually was expelled after corticosteroid therapy. CONCLUSIONS: Capsule endoscopy correctly diagnosed or excluded a bleeding source, small-bowel polyps, or Crohn's disease of the small bowel in 29 of 30 patients. Capsule endoscopy permits an accurate, noninvasive approach for diagnosing obscure small bowel lesions in children over the age of 10.

Adolescent↗

PubMed2000

The effect of gelatin cross-linking on the bioequivalence of hard and soft gelatin acetaminophen capsules.

PURPOSE: To determine if changes in the in vitro dissolution of hard and soft gelatin acetaminophen capsules, which result from gelatin crosslinking, are predictive of changes in the bioavailability of the capsules in humans. METHODS: Both hard and soft gelatin capsules were "stressed" by a controlled exposure to formaldehyde, resulting in unstressed, moderately stressed and highly stressed capsules. In vitro dissolution studies were conducted using water or SGF with and without pepsin as the media. Separate 24-subject, 3-way crossover human bioequivalence studies were performed on the unstressed and stressed acetaminophen capsules. Plasma acetaminophen was determined by high performance liquid chromatography (HPLC) for 12 hr after each dose. RESULTS: The in vitro rate of dissolution of hard and soft gelatin capsules was decreased by crosslinking. The bioequivalence studies showed that both hard and soft gelatin capsules, which failed to meet the USP dissolution specification in water, but complied when tested in SGF containing pepsin, were bioequivalent to the unstressed control capsules. The capsules that were cross-linked to the greatest extent were not bioequivalent to the unstressed control capsules, based on Cmax. A trend toward an increase in Cmax with increased level of cross-linking was observed, but this was only significant for the severely stressed capsules. CONCLUSIONS: On the basis of this study a two-tier in vitro dissolution test was developed using enzymes to distinguish between bioequivalent and bioinequivalent gelatin capsules.

Acetaminophen↗