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At least 19 recordsLinked to original sources
PubMed2006

A scintigraphic investigation of the disintegration behaviour of capsules in fasting subjects: a comparison of hypromellose capsules containing carrageenan as a gelling agent and standard gelatin capsules.

Two-piece hard shell capsules made from hypromellose (or hydroxypropyl methylcellulose, HPMC) have been proposed as an alternative to conventional gelatin capsules for oral drug delivery; however, little is known about their in vivo behaviour. The aim of this study was to compare the disintegration of HPMC and gelatin capsules in fasted human subjects using the technique of gamma scintigraphy. HPMC capsules containing carrageenan as a gelling agent (QUALI-V(R), Qualicaps) and gelatin capsules (Qualicaps) of size 0 were filled with a lactose-based mixture. The capsules were separately radiolabelled with indium-111 and technetium-99m. Both capsules were administered simultaneously with 180ml water to eight healthy male subjects following an overnight fast. Each volunteer was positioned in front of the gamma camera and sequential 60s images were acquired in a continuous manner for 30min. No differences in the oesophageal transit of the two types of capsules were noted, with the capsules arriving in the stomach in a matter of seconds. All the capsules disintegrated in the stomach. The mean (+/-S.D.) disintegration time for the HPMC capsules was 9+/-2min (range 6-11min). The corresponding mean time for the gelatin capsules was 7+/-4min (range 3-13min). These disintegration times were not significantly different (P=0.108, paired t-test). In conclusion, HPMC and gelatin capsules show rapid and comparable in vivo disintegration times in the fasted state. HPMC capsules containing carrageenan as a gelling agent therefore offer a practical alternative to gelatin capsules as an oral drug delivery carrier.

Adult↗
PubMed1984

The growth and survival of capsulate and non-capsulate Bacteroides fragilis in vivo and in vitro.

The growth of capsulate and non- capsulate Bacteroides fragilis in chambers implanted in the mouse peritoneal cavity was compared. Capsulate and essentially non- capsulate (less than 1% capsulate ) populations of B. fragilis strains NCTC9343 and NCTC10584 consistently grew exponentially to greater than 10(9) cfu/ml within 24 h in vivo, and low numbers of capsulate bacteria were maintained in the essentially non- capsulate population; however, the degree of capsulation of the capsulate population decreased by more than 60%. B. fragilis ATCC23745 differed from strains NCTC9343 and NCTC10584 in that growth was unpredictable and only occurred in some of the implanted chambers. Capsule production by cells of strain ATCC23745 varied from chamber to chamber: sometimes the proportion of capsulate cells increased after prolonged implantation. This could occur with either an increase or decrease in viable numbers in vivo and also after in-vitro incubation of this strain in chambers. The survival of capsulate and non- capsulate B. fragilis strains NCTC9343 and ATCC23745 was compared in aerobic and anaerobic conditions in vitro. In anaerobic conditions, capsulate and non- capsulate strain NCTC9343 survived equally well, whereas capsulate ATCC23745 survived better than its non- capsulate variants. Capsulate populations of both strains survived better than non- capsulate in aerobic conditions.

Aerobiosis↗
PubMed2005

Clinical evaluation of the use of the M2A patency capsule system before a capsule endoscopy procedure, in patients with known or suspected intestinal stenosis.

BACKGROUND AND STUDY AIM: The main complication of video capsule endoscopy (VCE) is the blocking of the capsule by a gastrointestinal stenosis. The "patency capsule" is a self-dissolving capsule that is the same size as the video capsule. It contains a radiofrequency identification (RFID) tag that allows it to be detected by a scanning device placed on the abdominal wall. When its passage is blocked by a stenosis, the patency capsule dissolves in 40-80 hours after ingestion. The aim of this study was to evaluate the usefulness of this system in patients with suspected intestinal stenosis but also requiring VCE. PATIENTS AND METHODS: 22 patients (16 men; 46 +/- 18 years; 15 with diagnosed or suspected Crohn's disease, two with suspected intestinal tumor, and two on nonsteroidal anti-inflammatory drugs) were first investigated with an abdominal CT plus enteroclysis (entero-CT, n = 15) or a small-bowel follow-through (SBFT, n = 7). The patency capsule was then administered at around 09.00 to fasting patients. The presence of the patency capsule in the digestive tract was assessed 30 hours later using the hand-held scanner. When the patency capsule was detected, a plain abdominal film was obtained, and this was repeated every 24 hours until capsule expulsion. RESULTS: At 30 hours after ingestion, the patency capsule was detected in 17 patients (72.3 %): in the area of the small intestine (n = 6) and in the colon (n = 11). In all the patients in whom the capsule was blocked in the small intestine, the stenosis had been suspected on CT or SBFT. In three patients, the delay in progression of the patency capsule led to cancellation of the VCE procedure. In three patients, the patency capsule induced a symptomatic intestinal occlusion, which resolved spontaneously in one and required emergency surgery in two. Although these two patients would have been obliged to undergo operation for their primary disease in any case, the procedure had to be brought forward. In one patient, the capsule passed through the stenosis without symptoms. All patients in whom the progression of the patency capsule was delayed had an established or suspected diagnosis of Crohn's disease. CONCLUSIONS: The current technical development of the patency capsule limits its use in clinical practice, as it did not detect stenoses undiagnosed by CT or SBFT. The start of dissolution at 40 hours after ingestion is too slow to prevent episodes of intestinal occlusion. Patients with Crohn's disease are most likely to be at risk of blockage of progression of the capsule and should benefit from a CT investigation before VCE. However, a careful interview eliciting the patient's medical history and symptoms remains the most useful indicator with regard to suspicion of an intestinal stenosis.

Adolescent↗
PubMed2006

Immunoproteomic analysis of capsulate and non-capsulate strains of Lactococcus garvieae.

A comparative immunoproteomic study was carried out to investigate the immunogenicity of capsulate (KG9408) and non-capsulate (NSS9310) strains of Lactococcus garvieae. Immunoblot assays, following two-dimensional gel electrophoresis (2-DE) for L. garvieae strains, revealed a significant difference between anti-capsulate and anti-non-capsulate rabbit sera with respect to the number and antigenicity of antigenic spots. Anti-capsulate and anti-non-capsulate rabbit sera reacted with an average of 72 and 127 antigenic spots, respectively. The strong reaction of anti-non-capsulate sera with elongation factor (EF)-G and -Tu, and GMP synthase, of the L. garvieae strains identifies these as specific major antigens. This study clearly demonstrates the differences in 2-DE immunoblot profiles between the capsulate and non-capsulate strains of L. garvieae. These differences may be the reason for variations in immunogenicity between capsulate and non-capsulate strains. Glyceraldehyde-3-phosphate dehydrogenase, phosphoglycerate kinase, arginine deaminase and ornithine carbamoyltransferase were identified from the 2-DE immunoblot profiles of both strains. Therefore, these common antigens are potential markers for the development of vaccines against L. garvieae, irrespective of strain. Immunoproteomics, a powerful tool for studying antigens at the proteomic level, allowed a comparative investigation of the immunogenicity of capsulate and non-capsulate strains of L. garvieae for vaccine development.

Animals↗
PubMed1997

Capsule opacification after refilling the capsule with an inflatable endocapsular balloon.

PURPOSE: To describe the features of capsule opacification in rabbits and cynomolgus monkeys after the capsules were refilled with an inflatable endocapsular balloon. SETTING: Nishi Eye Hospital, Jinshikai Medical Foundation, Osaka, Japan. METHOD: Capsule opacification was evaluated by slitlamp examination, Miyake view, and histopathological examination in 15 eyes of 15 rabbits and 16 eyes of 13 primates from 4 to 32 months after the lens capsule had been refilled. RESULTS: The incidence of capsule opacification was 94%. In the eyes that did not have lens epithelial cell (LEC) removal, a monolayer of LECs was seen on the posterior capsule when the lens capsule was tautly refilled, whereas a thick layer was seen when the lens capsule was moderately or poorly refilled. In the eyes that had LEC removal, the opacification was generally less marked regardless of the amount of refilling. In two rabbit capsules that were refilled moderately or tautly and had LEC removal, the capsule remained clear. Neodymium:YAG capsulotomy in two eyes did not cause herniation of the injected silicone. CONCLUSIONS: Filling the capsule tautly and removing the LECs effectively reduced capsule opacification but could not completely inhibit LEC migration. This suggests the need for more efficient and thorough LEC removal or even a pharmaceutical approach to prevent capsule opacification after lens refilling.

Animals↗
PubMed2003

Effect of fill weight, capsule shell, and sinker design on the dissolution behavior of capsule formulations of a weak acid drug candidate BMS-309403.

Two strengths of BMS-309403 capsules were developed from a common stock granulation. Dissolution testing of the capsules was conducted utilizing the USP apparatus 2 (paddle) with a neutral pH dissolution medium. Unexpectedly, the lower-strength capsules exhibited slower dissolution than the higher-strength capsules filled with the same stock granulation. Higher variability was also observed for the lower-strength capsules. This was found to be mainly caused by a low fill weight in a relatively large size hard gelatin capsule shell. Instead of bursting open, some gelatin capsule shells softened and collapsed onto the granulation, which delayed the release of the active drug. The problem was aggravated by the use of coil sinkers which hindered the medium flow around the capsules. Switching from the gelatin capsule shells to the HPMC (hydroxypropyl methylcellulose) shells reversed the dissolution rate ranking between the two capsule strengths. However, both dissolved at a slower rate initially than the gelatin capsules due to the inherent dissolution rate of the HPMC shells at pH 6.8. Notably, the HPMC shells did not occlude the granulation as observed with the gelatin shells. The study demonstrated that the dissolution of capsule formulations in neutral pH media was significantly affected by the fill weight, sinker design, and capsule shell type. Careful selection of these parameters is essential to objectively evaluate the in vitro drug release.

Capsules↗
PubMed1985

Contraception with subdermal ST-1435 capsules: side-effects, endocrine profiles and liver function related to different lengths of capsules.

One Silastic capsule of 15 mm, 20 mm or 30 mm length was inserted subcutaneously into the ventral aspect of the left forearm or upper arm of 28 healthy women during menstrual bleeding or not later than on the seventh day of the menstrual cycle. A new capsule of the same length was inserted after six months and both capsules were removed twelve months after the first insertion. Side-effects, including changes in body weight, blood pressure, menstrual bleeding and liver function test results, were registered. Blood samples were taken from selected subjects twice a week during the 1st, 2nd, 3rd, 6th, 7th and 12th month of use. Plasma concentrations of ST-1435 were measured by radioimmunoassay and the effects of treatment on pituitary and ovarian function were determined by assaying plasma concentrations of LH, FSH, estradiol and progesterone. There were no differences in hormonal side-effects between subjects who had a 30 mm capsule or subjects who had 20 mm or 15 mm capsules, but subjects who had 20 or 15 mm capsules had significantly longer bleeding or spotting periods in comparison with subjects who had a 30 mm capsule. There were no changes in blood pressure, body weight or liver function test results in comparison with pre-insertion values. The plasma level of ST-1435 was not significantly higher during the use of 30 mm capsules than during the use of 20 or 15 mm capsules. During the use of the shorter ST-1435 capsules, plasma estradiol elevation and slightly suppressed FSH were seen, while the use of longer capsules resulted in a slight suppression of LH. Progesterone concentrations during monitored cycles indicated anovulation. No pregnancies occurred during the study period of one year. The continuation rate at one year was 71% in the 30 mm capsule group and 57% in the 20 and 15 mm capsule groups taken together.

Adult↗
PubMed1998

A study on gelatin capsule brittleness: moisture tranfer between the capsule shell and its content.

Variation in moisture content of the capsule shells either due to the change of storage conditions or the moisture transfer between the capsule shell and its contents may lead to undesired physical properties, such as capsule brittleness and stickiness. DMP 504, a developmental bile-acid sequestrant, is a strongly basic anion-exchange polymer which contains randomly distributed primary, secondary, tertiary, and quaternary amine groups in their hydrochoride salt form. The alkylammonium groups which comprise this polymer form a random network containing a high level of branching and a low level of cross-linking. DMP 504 is very hygroscopic and has a tendency to gain or lose moisture with ease. The transfer of moisture from the capsule shell to DMP 504 powder contained in a hard gelatin capsule can be expected, and if a low water content of the capsule shell is achieved, the capsules become brittle and fracture easily. The sorption isotherm for DMP 504 was generated by storing the drug substance under various relative humidity conditions. After equilibrium, the moisture contents for the samples of individual isotherm points were measured by thermogravimetric analyses. This report applies the sorption-desorption moisture transfer (SDMT) model to predict the equilibrium relative humidity in a system containing DMP 504 in hard gelatin capsules and to establish target loss on drying values for DMP 504 and the capsule shell. Application of this SDMT model resulted in finding a solution to the brittleness problem. The moisture levels of capsule shells and contents for two formulations in a 12-month stability program are also reported here. Results of this study further demonstrate that the SDMT model can be used as a tool to guide the formulator to select optimal initial moisture contents for the empty capsule shell and the formulation to avoid the incidence of brittle capsule problems.

Absorption↗
PubMed2002

Bioavailability and in vitro oesophageal sticking tendency of hydroxypropyl methylcellulose capsule formulations and corresponding gelatine capsule formulations.

The overall aim of the present study was to widen our knowledge about the biopharmaceutical behaviour of novel hydroxypropyl methylcellulose (HPMC)-based two-piece capsules by comparing them with the classic hard gelatine capsules. Firstly, the tendency of the HPMC capsules to stick to isolated porcine oesophageal preparation was evaluated. The force needed to detach the HPMC capsules from the oesophagus was significantly lower than that for the gelatine capsules (P<0.001), which is evidently an advantage of this new dosage form. The second aim was to investigate the possibility of preparing sustained-release capsules using different powdered HPMCs as diluents (K100, K4M and K15M) and the effect of the molecular weight of HPMC powder on the in vitro and in vivo behaviour of the capsules. In addition to peroral drug administration also rectal dosing was applied. Two groups of eight healthy volunteers participated in randomised, cross-over, single-dose studies. One group was administered capsules orally and the other rectally. There were no marked differences in the bioavailability properties of either the oral or rectal HPMC capsules containing ibuprofen as model drug as compared with corresponding gelatine capsule formulations. Using different viscosity grades of HPMC powders as diluents it was possible to control the absorption rate of the model drug both from gelatine and HPMC capsules as far as the oral route was concerned. After rectal administration there were no statistically significant differences between the formulations containing different grades of HPMC powder. Only partial correlation was observed between the results of the bioavailability studies and the in vitro dissolution studies. From a biopharmaceutical point of view these two shell materials can be regarded as interchangeable.

Administration, Oral↗
PubMed2004

Frequency and clinical outcome of capsule retention during capsule endoscopy for GI bleeding of obscure origin.

BACKGROUND: Capsule endoscopy is now commonly performed for GI bleeding of obscure origin. Regional transit abnormality refers to slowed capsule movement during capsule endoscopy. The frequency and clinical outcome of capsule retention and regional transit abnormalities are unknown. METHODS: Initial capsule endoscopies performed at a single institution in 52 patients with GI bleeding of obscure origin were reviewed retrospectively. For patients with capsule retention or regional transit abnormality, preprocedural characteristics, and post-procedural outcomes were recorded. OBSERVATIONS: Capsule retention occurred in 7 patients, all of whom remained asymptomatic. Regional transit abnormality was noted in 3 patients. Sources of bleeding were localized in all cases. Seven patients underwent surgery. Stricture induced by non-steroidal anti-inflammatory drugs was the major cause of retention. In all patients, anemia resolved during follow-up. CONCLUSIONS: Capsule retention and regional transit abnormality occurred in almost 20% of patients who had capsule endoscopy for GI bleeding of obscure origin. These capsule movement abnormalities led to the diagnosis of bleeding sources and thereby influenced patient management. A history of non-steroidal anti-inflammatory drugs use may be associated with an increased risk of capsule retention.

Aged↗
PubMed2001

The effect of host factors and capsule composition on the cellular overgrowth on implanted alginate capsules.

Microencapsulation of islets of Langerhans in alginate/poly-L-lysine (PLL)/alginate capsules may provide a method for transplantation in the absence of immunosuppression. The aim of this study was to investigate the problem of overgrowth on implanted capsules with regard to the composition of the capsules and host factors such as cytokine and nitric oxide production. Empty capsules were implanted to C57BL/6 mice for 1, 3, 7, or 28 days. Glucose oxidation rates showed the metabolic activity of the cellular overgrowth on retrieved capsules. DNA content, histological score, and retrieval rates were also measured to assess the overgrowth. It was noted that the pericapsular host reaction arose by day 7 and had not increased further by day 28. Capsules of varying alginate compositions and different concentrations of PLL were implanted for 7 days to either C57BL/6 or Balb/c mice. Capsules were also implanted to mice lacking the inducible nitric oxide synthase enzyme. Glucose oxidation rates, DNA content, and histological score were positively correlated to each other and negatively correlated to retrieval rates. The pericapsular reaction was reduced if PLL was omitted from the capsule or if a high mannuronic acid alginate was used. Balb/c mice had reduced cellular overgrowth on implanted capsules and had reduced mRNA expression of interleukin-1 beta and tumor necrosis factor-alpha in their peritoneal macrophages. The capsular overgrowth seemed more severe in animals lacking inducible nitric oxide synthase compared with wild-type controls. It is concluded that alginate composition, PLL, and recipient factors such as nitric oxide production and cytokine expression affect the cellular overgrowth on implanted alginate capsules.

Alginates↗
PubMed2006

Dynamics of capsule swallowing by healthy young men and capsule transit time from the mouth to the stomach.

We examined the dynamics of capsule swallowing by healthy young men using the anterior-posterior view of videofluoroscopy as a first step in a study on capsule swallowing by dysphagic patients. The subjects were 14 healthy men who did not have any complaint of dysphagia. They were asked to swallow a #4 hard gelatin capsule filled with barium sulfate with 15 ml of water during the videofluoroscopic examination. This examination was repeated three times for each subject (total of 42 trials). In four of the 14 subjects, a swallowed capsule was retained at the upper esophageal sphincter, or the broncho-aortic constriction of the esophagus, or the lower esophageal sphincter. Except where retention occurred, the average capsule transit time from the mouth to the stomach was 6.0 +/- 2.4 s. Three of the four subjects who had capsule retention did not realize that the swallowed capsule was retained en route to the stomach. By considering the dynamics of swallowing a capsule with 15 ml of water in healthy men, we should be able to reveal the dynamics of capsule swallowing in dysphagic patients, and the capsule transit time from the mouth to the stomach.

Adult↗
PubMed2004

The effect of lens edge design versus anterior capsule overlap on posterior capsule opacification.

PURPOSE: To determine whether lens edge design or anterior capsule overlap on the intraocular lens (IOL) has greater effect on posterior capsule opacification (PCO). DESIGN: Retrospective cohort clinical study. METHODS: Retrospective. SETTING: Academic clinical practice. PATIENT POPULATION: The patient population consisted of 259 uncomplicated surgical patients (259 eyes) with no confounding comorbidity and at least 1 year of follow-up after surgical placement of a silicone or hydrophobic acrylic lens. OBSERVATION PROCEDURES: Digital retroilluminated photographs were taken to ascertain PCO, anterior capsular opacification (ACO), previous neodymium:YAG capsulotomy and degree of anterior capsule overlap on the IOL optic. MAIN OUTCOME MEASURES: PCO, ACO, YAG capsulotomy rate, and anterior capsule overlap on the IOL optic. RESULTS: One hundred forty-eight digital images (74 silicone and 74 acrylic) were measurable for both anterior capsule overlap and PCO. Complete 360 degrees of anterior capsule overlap on the IOL was associated with decreased PCO (P = <.001). A significant negative correlation was found between the degree of anterior capsule overlap and PCO (P = <.001). Evaluation of PCO, and YAG capsulotomy rates were similar between acrylic and silicone lenses. Minimal anterior capsule overlap may also be associated with PCO prevention. CONCLUSIONS: Implanting a lens with complete anterior capsule overlap on the IOL was found to significantly reduce PCO, which advantage appeared to be greater than PCO prevention by a truncated, sharp edge IOL design.

Acrylic Resins↗
PubMedDate not supplied

The effect of capsule composition on the biocompatibility of alginate-poly-l-lysine capsules.

The encapsulation of islets of Langerhans in alginate-poly-l-lysine has been proposed as a method for the immunoprotection of transplanted islets. Although several capsule compositions have been reported, there has been no published study concerning the effect of capsule composition on the severity of the foreign body reaction. Empty capsules were prepared from high mannuronic acid alginate and were coated with: (1) poly-l-lysine alone, (2) poly-l-lysine plus high guluronic acid alginate, or (3) poly-l-lysine plus high mannuronic acid alginate. The capsules were placed in the renal subcapsular space or the peritoneal cavity, and retrieved after three weeks of histological examination. The recipients were WAG/01a, nude (athymic), diabetic BB, and non-diabetes prone BB rats. The severity of reaction to the capsules was determined by measuring the thickness of the pericapsular cell infiltrate or by a scoring system. The severity of the reaction to the capsules was strain-dependent in both the renal and peritoneal sites, with the BB and nude rats displaying the most severe responses. The degree of response was not affected by capsule composition in the renal subcapsular space, but in the peritoneum, the high mannuronic acid alginate capsules provoked the weakest response, and this type of capsule will be used for future transplantation work. The infiltrating cells were characterised by immunohistochemistry and electron microscopy and found to be mostly fibroblasts and macrophages.

Alginates↗
PubMed1981

Effect of implant location on compressibility and capsule formation around miniprostheses in rats, and experimental capsule contracture.

Our study of experimental contracture in rats confirms the existence in laboratory animals of a phenomenon very much like human capsule contracture. The ultrastructural features of capsules in rats are essentially identical to those for humans and rabbits. Macrophages with silicon-containing material were present. Star-shaped myofibroblasts with extended processes appeared in contracted and noncontracted capsules. The myofibroblasts contained bundles of 60 to 80 A microfilaments with included dense bodies, convoluted nuclei, and extensive peripheral vesiculation. The myofibroblasts tended to be associated with more extensive ground substance and smaller diameter extracellular fibrils than were normal synthetic fibroblasts. The incidence of contracture was similar for implants beneath different amounts of overlying soft tissue dorsally and sternally, while compressibility and subjective softness were greater for implants beneath lesser amounts of overlying tissue. A greater mass of capsule formed beneath the heavier covering, however, suggesting that in clinical experience, cosmetically more acceptable results from submuscular prosthesis placement are probably due to a padding effect. Capsule glycosaminoglycans were primarily hyaluronic acid and dermatan sulfate. The occurrence of myofibroblasts in these capsules at a relatively late period (26 weeks) implicates myofibroblasts in the contracture mechanism, but details are still unknown. Contracture is a property of the capsule tissue; preliminary observations suggest that its occurrence is independent of species, anatomical site, surgical procedure, presence of extruded gel, presence of myofibroblasts, capsule thickness, or protein, collagen, or glycosaminoglycan composition. Cells within the capsule were geometrically asymmetrical, being extremely flattened in the plane parallel to the prosthesis surface.

Animals↗
PubMed2004

Anterior capsule relationship of the AcrySof intraocular lens optic and posterior capsule opacification: a prospective randomized clinical trial.

OBJECTIVE: To evaluate the relationship of the anterior capsule and the AcrySof MA30BA intraocular lens (IOL) and its impact on the development of central posterior capsule opacification (PCO). DESIGN: Prospective, randomized, controlled trial. PARTICIPANTS: Two hundred two patients with senile cataracts received an AcrySof IOL between July and December 1998 at Iladevi Cataract and IOL Research Center, Ahmedabad, India. INTERVENTION: Patients were randomized prospectively to receive 1 of the 3 possibilities of anterior capsule and IOL optic relationship: group 1, total anterior capsule cover (360 degrees ) of the optic; group 2, no anterior capsule cover (360 degrees ) of the optic; group 3, partial anterior capsule cover (<360 degrees ) of the optic. After surgery, slit-lamp video photography was performed every 6 months for 3 years. Analyses of variance and chi-square tests were used to compare treatment groups. MAIN OUTCOME MEASURES: Incidence of PCO in the 3 groups. The posterior capsule was divided into 3 zones: peripheral, central 3 mm, and midperipheral (the space between the peripheral and the central zones). RESULTS: The average follow-up was 35.3 +/- 1.52 months in all the groups. At 3 years, the rate of central PCO was 6.4% in group 1, 7.1% in group 2, and 5.9% in group 3 (P = 0.9). Midperipheral PCO was present in 24.2% in group 1, 16% in group 2, and 20.6% in group 3 (P = 0.9). Peripheral PCO was seen in 100% of patients in all groups. The neodynium:yttrium-aluminum-garnet laser (Nd:YAG) posterior capsulotomy rate was 0% in all groups. CONCLUSIONS: There was no significant difference in the incidence of development of central PCO among the 3 groups. No patient experienced central PCO that required Nd:YAG capsulotomy. When using the AcrySof IOL model MA30BA, the relationship of the anterior capsule and the IOL does not seem to be a factor that relates to the development of central PCO.

Acrylic Resins↗
PubMed2000

Bioequivalence study of stressed and nonstressed hard gelatin capsules using amoxicillin as a drug marker and gamma scintigraphy to confirm time and GI location of in vivo capsule rupture.

PURPOSE: Evaluate if crosslinked hard gelatin capsules (HGCs) having different in vitro dissolution profiles changed in vivo release times or altered bioavailability of a drug marker; assess if a two-tier dissolution test (with and without enzyme) predicted in vivo performance. METHODS: Two classifications of stressed HGCs were artificially produced by exposure to formaldehyde (HCHO). HGCs were categorized as, a) pass/pass (p/p) which met in vitro dissolution criterion (75% drug dissolution at 45 min), b) moderately crosslinked fail/pass (f/p) which failed dissolution criterion in the absence of enzymes and passed in the presence of enzymes, and c) severely crosslinked fail/fail (f/f) which failed in vitro standards with or without enzymes. A six-way, single dose bioequivalence study (n = 10) administered the three HGCs under the fasted and fed condition. In vivo capsule rupture and GI transit were monitored via gamma scintigraphy, and blood samples were collected through six hours. RESULTS: Each crosslinked HGC was bioequivalent to the control p/p capsule when using AUC(0-infinity) and Cmax for comparison. Mean in vivo disintegration of the p/p capsule was 7 +/- 5 min for the fasted condition and 11 +/- 7 min for the fed condition. In vivo rupture for the f/p capsule was 22 +/- 12 min and 23 +/- 11 min for the fasted and fed studies, respectively, while the f/f HGC ruptured at 31 +/- 15 min and 71 +/- 19 min under the fasted and fed condition, respectively. Onset of amoxicillin absorption was dependent on in vivo HGC rupture and subsequent entry of the released radioactive marker into the small intestine. Consequently, fasted Tmax values were significantly later for the f/p HGC (1.62 +/- 0.53 hr) and f/f HGC (1.85 +/- 0.58 hr) as compared to the p/p HGC (1.17 +/- 0.30 hr). Fed Tmax values were statistically different only for the f/f capsule (2.55 +/- 0.44 hr) where Tmax values for the p/p and f/p HGCs under the fed condition were 1.50 +/- 0.47 hr and 1.60 +/- 0.46 hr, respectively. CONCLUSIONS: A two-tier dissolution procedure that retested a crosslinked hard gelatin capsule with addition of gastric or intestinal enzymes provided an adequate in vitro indicator of the formulation's in vivo performance. The observed delays in the onset of amoxicillin absorption and Tmax for the severely crosslinked f/f HGC was attributed to delayed in vivo capsule rupture, however, this delay did not adversely change AUC(0-infinity) nor Cmax.

Adult↗