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At least 19 recordsLinked to original sources
PubMed1993

Membrane filtration of pharmaceutical solutions.

The principles and uses of membrane filtration in the preparation of pharmaceutical solutions are discussed. The preparation of pharmaceutical solutions often requires their passage through a thin polymeric membrane containing many tiny pores. The purpose is to remove viable and nonviable particles in order to clarify or sterilize the solution. Particles may be retained by sieving, entrapment, or electrostatic attraction. The largest pore size that will yield a sterile filtrate is 0.2 microns. Membrane filters are either hydrophobic or hydrophilic. The rate of flow through a filter is affected by the resistance of the filter, the viscosity of the solution, and pressure. Filters are commonly composed of mixed esters of cellulose, polysulfone, polyvinylidene difluoride, nylon 66, polycarbonate, or polytetrafluoroethylene. In selecting a membrane filter, a pharmacist must consider pore size, compatibility, fluid volume, particulate load, and the filter holder. Various tests are available to evaluate the integrity of filters. Filters are useful in testing end products for sterility. The use of an in-line filter during the administration of large-volume injectable solutions can prevent the introduction of particles, air, and microorganisms into the patient. Therapies in which a 0.2-micron filter may be contraindicated include lipid emulsions, low-dose infusions, low-volume infusions, drugs for which the pharmacologic properties are altered by the membrane filter, and drugs that adhere to the membrane. Pharmacists need an in-depth understanding of the principles of filtration, the characteristics of filters, and their use in the filtration of pharmaceutical solutions.

Drug Compounding↗
PubMedDate not supplied

Volatile hydrocarbons in pharmaceutical solutions.

Volatile pollutants such as hydrocarbons have, during many years, been analysed in small concentrations in air, water, food, pharmaceutical solutions, and human blood and tissues. It has also been shown that such substances have unexpected consequences for cell cultures and scientific experiments. These substances also accumulate in patients receiving haemodialysis and these patients are exposed to quite high concentrations. The knowledge of the toxicity of such compounds has led to the development of maximum limit concentrations with the aim to decrease the exposure of humans. This paper discusses the problems of human exposure in general and especially through pharmaceutical solutions, and the possibilities of eliminating such compounds with the aim of decreasing the exposure as a hygienic challenge.

Finland↗
PubMed2002

Insulin aspart (AspB28 human insulin) derivatives formed in pharmaceutical solutions.

PURPOSE: To isolate and identify the main insulin aspart (AspB28 human insulin) derivatives formed in pharmaceuticals (pH 7.4 at 5 degrees C), to estimate rates of formation, and to determine their biologic potencies. METHODS: Insulin aspart derivatives have been isolated by reversed-phase high-performance liquid chromatography (RP-HPLC), and identified by RP-HPLC, peptide mapping, amino acid analysis, mass spectrometry. and N-terminal amino acid sequence analysis. RESULTS: The main derivatives formed were isoAspB28, isoAspB3, AspB3, and desPheB1-N-oxalyl-ValB2 insulin aspart. At 5 degrees C, the rate constants were 0.00028/month for isoAspB28 and isoAspB3, 0.00024/month for AspB3, and 0.00013/month for desPheB1-N-oxalyl-ValB2 derivatives of insulin aspart. Unexpectedly, the rate of isomerization of B28 was high compared to the rate of B3 deamidation at both 5 degrees C and 45 degrees C. The N-terminal and especially the C-terminal of the B-chain are highly flexible, which may explain the high rate of isoAspB28 formation and that deamidation of AsnB3 occurs. All the derivatives had full in vivo biologic potencies. CONCLUSION: Except for isoAspB28 insulin aspart, the main derivatives formed in pharmaceuticals of insulin aspart and human insulin at pH 7.4 are similar. They are all fully active in vivo. In proteins, flexibility of the polypeptide chain seems more important than sequence in the formation of succinimides.

Amino Acid Sequence↗
PubMed1992

[Molecular interaction in pharmaceutical solution, solubilization, partition, and stability of drugs].

The pharmaceutical studies carried out by the author during 40 years were reviewed from the viewpoint of molecular interaction. Included subjects are: electrostatic interaction between drug ions, ion pair formation and its partition to organic phase, drug solubilization by adjuvants, partition of drugs between aqueous and micellar phases, cyclodextrin inclusions, human serum albumin binding and drug stability related to the esterase-like activity of the albumin, and oral liposome preparation of vitamin K1. The drug stabilities related to those molecular interactions were emphasized.

Drug Stability↗
PubMed2005

Development of a simple method for predicting the levels of di(2-ethylhexyl) phthalate migrated from PVC medical devices into pharmaceutical solutions.

This study deals with the development of a simple method for predicting the elution levels of di-2-ethylhexyl phthalate (DEHP) from medical devices made of polyvinyl chloride (PVC) by using the physicochemical properties of pharmaceutical injections as a marker. GC-MS analysis showed that the release of DEHP from medical grade PVC product was concentration-dependently increased by extraction with two kinds of lipophilic injections (Sandimmun and Prograf) and three kinds of surfactants (HCO-60, Tween 80, and SDS). The solubility of lipophilic pigments such as Sudan III, methyl yellow, and 1,4-diamino-anthraquinone against these solutions were also increased in a concentration-dependent manner, in which methyl yellow showed the highest response regarding the increase of optical density (O.D.). Further, electrical conductivity and static contact angle to the PVC sheet of the solutions were also increased or decreased in the same manner. As a result of the comparative study, significant correlation was found between DEHP release levels and these three physicochemical properties, particularly methyl yellow solubility, of the solutions tested. To evaluate the relationship in detail, DEHP release levels from PVC tubing and methyl yellow solubility of 53 injections used in gynecologic and obstetric fields were determined. None of the hydrophilic medicines showed any significant release of DEHP, and all showed low solubility of methyl yellow. On the other hand, the lipophilic medicines releasing a large amount of DEHP showed high solubility of methyl yellow (greater than O.D. 0.8). These results indicate that a significant proportional relationship exists between DEHP release potency and methyl yellow solubility of pharmaceutical solutions, and the risk of DEHP exposure to the patients administered pharmaceuticals through transfusion set could be easily predicted by the solubility test without complicated elution tests of DEHP using GC-MS or LC-MS.

Diethylhexyl Phthalate↗
PubMedDate not supplied

Depyrogenation of pharmaceutical solutions using submicron and ultrafilters.

The effect of varying the pH and ionic strength on endotoxin removal (depyrogenation) from Water for Injections (WFI) was investigated. Studies using submicron filters showed that endotoxin aggregation and filter retention increased with increasing molarity and decreasing pH. Using a Sartorius 0.01 micron filter, greater than 98% endotoxin retention could be achieved with 10 endotoxin units (EU)/ml bulk solution, and greater than 97% endotoxin retention with the 500 EU/ml bulk solution. Depyrogenation of active and placebo solutions of the radiopaque, Iohexol (350 mgI/ml), using ultrafilters of varying nominal molecular weight limit (NMWL 10,000-300,000) and a Pall Posidyne 0.2 micron filter was also investigated. Results with the ultrafilters showed that it was possible to increase the molecular weight cut-off of an ultrafilter from 10,000 to 100,000, without affecting the efficiency of endotoxin removal, thereby increasing flow rate and reducing filtration time. The Posidyne filter was able to depyrogenate Iohexol active and placebo product. The use of submicron filtration in place of ultrafiltration would provide significant cost benefits in terms of filtration time and equipment costs, and they have been shown to be capable of efficient depyrogenation of these pharmaceutical products.

Endotoxins↗
PubMed1981

Test for reproducibility of metered-dose aerosol valves for pharmaceutical solutions.

Seven independent testing sites received metered-dose aerosols containing a standard test solution to assess a newly designed protocol for studying the reproducibility of metered-dose aerosol valves. In accordance with the rather small sampling protocol design, the amount of product dispensed per actuation was measured over the life of the aerosol at designated regions of actuation. A statistical analysis of the data collected at each testing site clearly indicated that the testing protocol is sufficiently reliable and workable for assessing the reproducibility of valve delivery for a given lot of metered-dose valves.

Administration, Inhalation↗
PubMed1987

Determination of trace levels of oxytocin in pharmaceutical solutions by high-performance liquid chromatography.

A high-performance liquid chromatographic assay has been developed for quantitating oxytocin in common large volume parenteral intravenous solution matrices. Separation is accomplished by a reversed-phase mechanism using a C18 column. The analyte is detected fluorimetrically after post-column derivatization with fluorescamine. Reaction efficiency is controlled by the use of a reaction buffer which is added separately from the fluorescamine via a dual pump reactor system. Given the low analyte concentration [40 parts per billion (10(9)) or less], the samples are concentrated on-line through the use of a trapping column and switching valve. To improve productivity, pre-concentration and analysis of adjacent samples is timed to occur concurrently. Performance of the assay is characterized by a high degree of accuracy, precision and ruggedness; the system is capable of distinguishing between the analyte, matrix components, impurities and common degradates.

Chromatography, High Pressure Liquid↗
PubMed1997

[Study on particle contamination produced by syringe needles and rubber stoppers for pharmaceutical solutions].

The contamination of particles produced by syringe needles and rubber stoppers for pharmacal solution of venous transfusion was studied. The results showed that the contamination of particles was positive correlation with the usage frequency of syringe needles, so the syringe needles for single use were suggested. To compare two kinds of syringe needles with different structure (side hole and incline), the result was that the difference of particle contamination between them was similar and without statistic significance. The particles contamination produced by primary and used rubber stoppers which was protected by polyester film was studied. It was shown that the difference between them was no significant statistically. The results of this study supplyed a scientific evidence about repeated use of rubber stoppers.

Drug Contamination↗