Study of eye drops dispensing and dose variability by using plastic dropper tips.

  1. The application of eye drops from flexible dropper bottles fitted with different types of dropper tips is associated with the high variability of eye drop weights. The aim of this report was to investigate the simultaneous effect of three factors influencing the mean weight of drops dispensing from two plastic dropper tips.
  2. Using a designed experiment (Box-Behnken), the effect of the concentration of benzalkonium chloride solutions (BAC) in the range of 0-0.02%, the dispensing angle from 90 degrees to 30 degrees from horizontal, and the residual volume of liquid in the dropper bottle from 4 to 10 mL on the mean drop weights were examined.
  3. The significant effect of the increase in BAC concentration resulted in a linear decrease in drop weights for both of the dropper tips investigated. The significant effect of the dispensing angle was influenced by the dropper tip design. For the dropper tip A, the effect of the dropper tip tilt was described by the quadratic equation with a minimum, which corresponded to the dispensing angle equal to that of 48 degrees from horizontal.
  4. Below this angle, the increase in drop weights occurred due to the drop formation from the wetted external surface of the tip orifice. The linear decrease in drop weights in response to the decrease in dispensing angle was detected for the dropper tip B. The regression equations and the contour line plots obtained allowed the drop weights to be estimated for the actual combinations of both the BAC concentration and the dispensing angle.
  5. The effect of the residual volume was found to be non-significant. Based on the formula of Tate’s law, the direct proportion between surface tension of a solution and the radius of the effective perimeter of a dropper tip can be used to estimate the theoretical maximal weight of drops at the dispensing angle of 90 degrees .
  6. Using the stalagmometric values of surface tension of the BAC solutions, the maximal drop weights were estimated for both of the dropper tips investigated. A comparison between the theoretical and the experimentally measured drop weights enabled the dropper tips behavior to be discussed by using Harkins and Brown correction factor F.
  7. The F-value of 0.74 noted for the dropper tip A differed from that of stalagmometer F-value (0.61) indicating a deviation from the simple drop formation process in answer to more complicated design of the dropper tip A. On the other hand, the F-value of 0.6 observed for the dropper tip B demonstrated the better consistency with stalagmometry.
  8. As a result, the dropper tip B with the linear decrease of drop weights in response to the increased concentration of BAC and the decreased dispensing angle without the adverse external drop Plastic bottles  formation could be recommended in real drop dispensing.

Tableting and stability evaluation of enteric-coated omeprazole pellets.

  • In this study, fluidized-bed manufactured enteric-coated omeprazole pellets were compressed into tablets. The stability of the pellets and those of compressed tablets were evaluated for remaining omeprazole and for degradation products under an accelerated stability protocol. The data were analyzed using the artificial neural network (ANN) and analysis of variance (ANOVA).
  • It was found that enteric-coated omeprazole pellets could be compressed into quickly disintegrating tablets using microcrystalline cellulose granules as the pressure absorbing matrix.
  • The ANN, using the multilayer perceptron model, predicted that there was a positive correlation between tablet crushing strength and microcrystalline cellulose concentration.
  • Microcrystalline cellulose matrix showed a strong plastic deformation and all the pellets inside the tablet maintained their integrity with no significant change in their surface properties.
  • Omeprazole degradation in acid medium was mainly dependent on microcrystalline cellulose concentration. A 90-day accelerated stability test in brown glass bottles with a desiccant showed that all prototype formulations would result in an acceptable stability profile for both remaining omeprazole, and also for the increase of impurity concentrations.
Brown Bottle 1000ml
Brown Bottle 1000ml

Studies on the light transmittance of coloured plastic bottles for liquid pharmaceutical preparations. Part 43: Contributions to problems concerning the use of plastic containers for liquid pharmaceutical preparations (author’s transl)

  1. To assess the light transmittance of coloured plastic bottles, studies were made using the photographic paper method and a spectrophotometric technique. According to its sensitivity between 400 and 500 nm, the photographic paper gives information as to this wavelength range, directional radiation and scattered light being covered.
  2. In contrast to this, the spectrophotometric method yields discriminating information on the wavelength range between 200 and 800 nm. Apart from a minimum transmittance up to 500 nm, the coloured plastic bottles should have a high transmittance greater than 700 to ensure high transparency.
  3. Of the dyes tested, Pigment Orange and Chromeophthal Brown give the plastic bottles light-protecting properties 4 years’ storage, both of these dyes show changes in the light-protecting properties by which the light transmittance of plastic bottles coloured with them is increased. When these dyes are used in adequate concentrations, this increase in light transmittance will remain within allowable limits, provided direct solar radiation be avoided.

Stability of Hydromorphone-Ketamine Solutions in Glass BottlesPlastic Syringes, and IV Bags for Pediatric Use.

  • To evaluate the stability of mixtures of hydromorphone and ketamine in 0.9% sodium chloride (normal saline [NS]) after storage for up to 7 days at room temperature (25°C).
  • The stability of 3 standard mixtures of hydromorphone and ketamine (hydromorphone 0.2 mg/mL + ketamine 0.2 mg/mL, hydromorphone 0.2 mg/mL + ketamine 0.6 mg/mL, and hydromorphone 0.2 mg/mL + ketamine 1.0 mg/mL) in NS was studied. Portions of each mixture were transferred to 3 brown glass bottles (100 mL), 3 plastic syringes (50 mL), and 3 IV bags (50 mL), which were then stored at room temperature (25°C). Physical characteristics, including pH, colour, and precipitation, were evaluated daily. Three 1.5-mL samples were collected from each bottle, syringe, and IV bag at baseline, at 24, 48, and 72 hours, and on day 7.
  • Samples were analyzed in triplicate by a stability-indicating high-performance liquid chromatography method. Solutions were considered stable if they maintained 90% of the initial concentration of each drug. Samples from syringes and IV bags were subjected to standard sterility testing by incubation for 5 days in an enriched culture media.
  • No notable changes in pH or colour were observed, and no precipitation occurred in any of the solutions. All formulations maintained more than 90% of the initial concentration of each drug on day 7. No bacterial growth was observed in any of the samples tested.

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Mixtures of hydromorphone and ketamine were stable for up 7 days at 25°C, and the sterility of the preparations was maintained. Because stability alone does not guarantee efficacy, it is recommended that clinical studies be conducted to evaluate the pharmacokinetics and pharmacodynamics of these formulations.

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