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58 records · Page 4Linked to original sources
PubMed1992

Influence of higher rates of agitation on release patterns of immediate-release drug products.

The dissolution procedure serves as a quality control test to assure batch-to-batch uniformity and bioequivalence of a product once the bioavailability of the product has been established. It can also be used to detect manufacturing and/or process variations that could reduce product bioavailability. Dissolution testing must be conducted at an appropriate agitation rate. Tests conducted at high agitation rates may lose the ability to differentiate between good and bad products. Although the effect of high agitation rates has been known for some time, several immediate-release drug products still have United States Pharmacopeia (USP) monograph dissolution procedures that require very high agitation rates. A systematic survey was conducted on marketed tablets of chloroquine phosphate, griseofulvin, hydroxychloroquine sulfate, isocarboxazide, primaquine phosphate, and sulfadiazine. Each of these products has a USP monograph requiring a dissolution test at a paddle speed of 100 rpm. To study the influence of agitation rate on the dissolution rate of these products, dissolution studies were conducted at paddle speeds of 50, 75, and 100 rpm with the USP apparatus 2 (paddle method). The dissolution rate increased with an increase in the agitation rate from 50 to 75 rpm. However, no significant increase in the dissolution rate was noted with an increase in the agitation rate from 75 to 100 rpm. The data support the position that the higher agitation rate of 100 rpm is not necessary for a quality control procedure or a compendial standard for the products tested.

Chloroquine↗
PubMed1989

Comparison of the pharmacokinetics and pharmacodynamics of two commercial products containing glibenclamide.

This investigation was carried out to evaluate the in vitro dissolution as well as the pharmacokinetic and pharmacodynamic properties of two tablet oral dosage forms of glibenclamide, Daonil (product A) and Glucomid (product B). The two products were found to comply with the compendial requirements for both disintegration and content uniformity. Further, the in vitro dissolution characteristics of the two products are similar. The bioavailability and pharmacodynamic studies were carried out on 16 healthy male adult volunteers who received a single dose of each product in a double-blind crossover design. Blood samples were obtained over a 12-h interval and analyzed for serum glucose by glucose-oxidase method, insulin by radioimmunoassay and glibenclamide by a sensitive HPLC assay. The two products were not found to be significantly different with respect to peak serum concentrations (187.9 +/- 13.3 and 167.6 +/- 9.1 ng.ml-1 for A and B, respectively) or to the corresponding peak times (4.2 +/- 0.2 and 4.1 +/- 0.2 h for A and B, respectively). Furthermore, the two products were not found significantly different in the extent of absorption as indicated by the area under serum concentration-time curve (1,118.0 +/- 86.7 and 986.5 +/- 75.1 ng.h.ml-1 for A and B, respectively). The two products were also found to be pharmacodynamically equivalent. This was reflected by the comparable serum glucose and insulin levels. These levels correlated very well with glibenclamide concentrations after the administration of each product. These findings indicate that the two products are bioequivalent in terms of bioavailability and pharmacodynamic effects in normal healthy males.

Adult↗
PubMed1994

Diaspirin crosslinked hemoglobin (DCLHb): characterization of the process and the product manufactured under GMP requirements for clinical studies.

Initiation of Clinical Trials in 1992 necessitated product manufacture under FDA Good Manufacturing Practice (GMP) requirements. To this end, all product components used were characterized to meet established requirements and processes and analytical methods were validated to confirm and document their utility and reproductibility. Manufacture of multiple 50+ liter lots of 10%g DCLHb under GMP requirements resulted in a pure and homogeneous product which reproducibly met a rigorous and complete set of product specifications. Final release testing of five consecutive GMP lots showed hemoglobin concentrations of 10.2 +/- 0.2g%, pH of 7.33 +/- 0.02 (37 degrees C), methemoglobin concentrations of 3.2 +/- 0.6%, degree of crosslinking of 99.8 +/- 0.1% and a P50 of 32.4 +/- 1.0 mmHg (37 degrees C). The mean overall yield for production of these five lots was 55 +/- 2%. Products were all endotoxin free as indicated by rabbit, cytokine and LAL testing (< 0.06 EU/mL); a critical characteristic for a molecule which may bind endotoxin. All lots were sterile as indicated by compendial testing.

Animals↗
PubMed2001

Epinephrine for the out-of-hospital (first-aid) treatment of anaphylaxis in infants: is the ampule/syringe/needle method practical?

BACKGROUND: Little information is available about administration of an accurate epinephrine dose to infants experiencing anaphylaxis outside the hospital setting. OBJECTIVE: Our purpose was to perform a prospective, controlled study of (1) the time needed by parents to draw up an infant epinephrine dose from an ampule and (2) the dose accuracy. METHODS: We gave 18 parents written instructions and asked them to draw up epinephrine 0.09 mL. We timed them by means of a stopwatch and measured the epinephrine content (in micrograms) in each dose by using HPLC-UV. Eighteen resident physicians, 18 general duty nurses, and 18 emergency department nurses served as controls. RESULTS: The parents took significantly longer (P < .05) than the controls to draw up the dose; the mean (+/- SEM) times were 142 +/- 13 seconds (range, 83-248) for the parents, 52 +/- 3 seconds (range, 30-83) for the physicians, 40 +/- 2 seconds (range, 26-71) for the general duty nurses, and 29 +/- 0.09 seconds (range, 27-33) for the emergency department nurses. The control groups did not differ significantly from each other in speed (P > .05). The epinephrine content of the doses drawn up by the parents ranged 40-fold in contrast to the physicians' doses (7- to 8-fold), general duty nurses' doses (3-fold), and emergency department nurses' doses (2-fold). The mean epinephrine content did not differ significantly (P > .05) among the 4 groups. CONCLUSIONS: Most parents were unable to draw up an infant epinephrine dose rapidly or accurately. Most health care professionals drew up the dose rapidly; however, their accuracy was compromised by inherent variations of epinephrine concentrations in the ampules (United States Pharmacopeia compendial limits, 90% to 115%) and the inherent difficulty of measuring low volumes (<0.1 mL) of epinephrine. User-friendly premeasured epinephrine doses suitable for infants should be developed.

Anaphylaxis↗