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PubMed2002

Single-dose pharmacokinetics of porcine factor VIII (Hyate C).

The objective was to establish the pharmacokinetic properties of porcine factor VIII (pFVIII) at three different doses in a single patient. The patient, born in 1952, had severe haemophilia A and developed an inhibitor to human FVIII (hFVIII) in 1966 aged 14 years. He was first treated with pFVIII in 1980. Apart from a short period of treatment with hFVIII in 1998 which resulted in the reappearance of the inhibitor, pFVIII has been constantly used since 1984. No inhibitor against human or porcine FVIII had been recordable over the 2-year period prior to the study. Three separate pharmacokinetic studies were performed using a washout period of 72 h and doses of 10 U kg (-1), 25 U kg (-1), or 50 U kg (-1), respectively, with sampling at preinfusion, then at 15 and 30 min and 1, 3, 6, 9, 12 and 24 h postinfusion. The FVIII levels were measured using both plasma derived one stage APTT based assay and chromogenic assay. The results were computed using a model-independent analysis and a model-dependent analysis. The respective clearances (mL h(-1)kg(-1)) at doses 50 U, 25 U or 10 U kg (-1) were 1.32, 1.33 1.8 (bioassay) and 2.54, 2.93, 9.43 (chromogenic). The respective half-lives (h) at doses 50 U, 25 U, and 10 U kg (-1) were 23.71, 16.54, 25.17 (bioassay) and 15.71, 17.39, and 10.66 (chromogenic). The respective recoveries (u dL(-1)/u kg(-1)) at doses 50 U, 25 U, and 10 U kg (-1) were 2.32, 2.44, 2.7 (bioassay) and 1.42, 1.16 and 0.9 (chromogenic). It was found that the two compartment model best fitted the curves of the bioassay and a one compartmental model best fitted the curves of the chromogenic assay. The pharmacokinetic studies are the first to be performed at different dose levels and using different assay methods for pFVIII. Using the bioassay, they show a long half-life and high recovery compared to hFVIII. The differences between the bioassay and the chromogenic assay reflect their different biological basis and are of relevance when potency labelling is performed using chromogenic assay (European Pharmacopeia).

Animals↗

PubMed2000

Novel online infusate-assisted dialysis system performs microbiologically safely.

Administration of adequate amounts of commercial infusion fluids renders modern convective dialysis modalities, such as hemodiafiltration, labor-intensive and costly. Preparation of infusate by cold sterilization of dialysis fluid, which is abundantly available, and its immediate (online) use, in contrast, enables a large volume fluid exchange in a cost-effective manner. Recent developments aimed at more hygienic and user-friendly online systems with increased operational flexibility. As a result the novel ONLINEplus system does not only provide online prepared infusate for convective dialysis therapy, but also for priming and rinsing of the extracorporeal blood circuit, for intradialytic bolus administration, and for re-infusion of patients' blood as well. Production of infusate from potentially impure dialysis fluid containing endotoxins and other pyrogens raises severe concerns of affecting the patients' well-being. To assess its safety, the online system was challenged with microbially contaminated dialysis fluid. Despite high levels of microbial counts (7.5 x 104 +/- 105 CFU/ml), endotoxin concentration (14.1 +/- 7.7 IU/ml and 9.265 +/- 3.000 IU/ml, as measured turbidimetrically and chromogenically, respectively) and cytokine-inducing activity (20,827 +/- 3,082 pg IL-1Ra/Mio WBC), we failed to detect contaminants in the final infusate during a 5 week laboratory testing period. In addition, infusate samples complied consistently with the European Pharmacopeia test for sterility. The present online system is comprehensive, operates user-friendly, and provides microbiologically safe infusate in large quantities. In this way, both patients and dialysis staff will benefit from improved dialysis therapy and reduced treatment-related labor burden, respectively. Moreover, convective dialysis modalities will become less expensive.

Analysis of Variance↗

PubMed2002

[Visual documentation of the stability of intravenous solutions of omeprazole (Losec) and pantoprazole (Pantoloc)].

Patients with complications of peptic ulcers, high grade reflux oesophagitis, or Zollinger Ellison syndrome need a sufficient permanent acid suppression. In appropriate indications they receive proton pump inhibitors (PPI) intravenously or via perfusion over a longer period, if an oral application is not possible. PPIs are prodrugs, which should be converted into the active principle in the acidic canaliculus at pH 1 of the parietal cell. Otherwise they would be activated prematurely. Immediate chemical degradation causes discolouration. Aim of the study was to compare pH stabilities of the intravenous formulations of Omeprazole (different solutions for infusion and injection) and Pantoprazole (one solution for injection and infusion). The solutions prepared accordingly to the official instructions, were exposed to four different light conditions. Both manufacturers (AstraZeneca Osterreich GmbH, Byk Osterreich Pharma Ges.m.b.H.) state reference solutions for acceptable discolouration. Those were prepared according to the European Pharmacopeia. Discolouration of solutions were evaluated as criterion for stability of the PPI prodrugs. If change of colour is at least of the extent of the corresponding reference solution, further use is no longer permitted. Optical alterations under different light conditions were compared and documented photographically with standardized illumination. Intensity and spectral composition of light as well as temperature had only minor influence on discolouration as measure of degradation of the prodrugs. Both formulations for injection fulfill the specifications for pH stability within the stated time frames mentioned in the summaries of product characteristics (SPC). Comparing both products, after a short period (1 hour) Omeprazole injectable formulation showed a substantial optical discolouration. After 6 hours these changes were more intense than the reference solution BG5 allows. Pantoprazole showed optical alteration to a notable later time point. After 24 hours discolouration reached the reference colour B6. Injectable formulation of Pantoprazole is about three times more stable than that of Omeprazole. Infusion solution of Omeprazole shows no optical alteration within the stated time frame due to high dilution and pH value. Assuming that 100 ml of the infusion solution contains 40 mg Omeprazole. It takes 5 hours for the volume to be infused at a dose regimen of 8 mg/h. Therefor 5 x 100 ml/24 h are needed.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed2001

Gastric acid suppression and treatment of severe exocrine pancreatic insufficiency.

Adding either H(2)-receptor antagonists (cimetidine or ranitidine) or proton pump inhibitors to an adequate amount of lipolytic activity improves fat malabsorption in most cases and abolishes steatorrhoea in up to 40% of children and adults with cystic fibrosis and in adults with chronic pancreatitis. Acid suppression improves fat absorption because the resultant increase in pH within the upper gastrointestinal tract improves the survival of lipolytic activity, reduces duodenal volume flow and prevents the precipitation of bile acids. These effects increase the concentration of intraduodenal lipolytic activity and promote the aggregation of bile acids and the micellar solubilization of lipid. The amount of lipase that should be recommended is controversial, but we interpret our studies as indicating that at least 90 000 United States Pharmacopeia (USP) units should be ingested with meals. This amount of lipolytic activity taken with an agent that suppresses gastric acid secretion improves fat absorption in most patients and may even abolish steatorrhoea.

Anti-Ulcer Agents↗

PubMed2002

Quantification of procyanidins in oral herbal medicinal products containing extracts of Crataegus species.

According to the European Pharmacopeia a photometric assay is used for the estimation of procyanidins in Crataegi fructus. This assay is also most commonly used for procyanidin analysis in herbal medicinal products (HMPs) containing extracts of hawthorn (Crataegus species). In order to find an appropriate method for the determination of oligomeric and polymeric procyanidins by analysing various preparations containing extracts of Crataegus, the Ph. Eur.-method was compared to an HPLC-method with chemical reaction detection (HPLC-CRD-method) and another conventional photometric assay using 4-dimethylamino-cinnamic-aldehyde (DMACA). Total procyanidins estimates obtained with the pharmacopeial method were, depending on the reference standard used, at least more than 50% higher than those obtained with the DMACA-assay. The determination of individual procyanidins could only be achieved by HPLC-CRD. Monomeric, dimeric, and trimeric procyanidins could be separated and detected individually, whereas no HPLC separation was possible for higher polymeric compounds. However, these compounds could be analysed as co-eluting groups. Using the DMACA method for the estimation of total oligomeric procyanidins and the HPLC-CRD method for quantification of the mono- up to trimeric procyanidins, some market leading herbal medicinal products from Germany containing extracts Crataegus species (C. monogyna Jacq., C. laevigata D.C., C. pentagyna Waldst. et Kit., C. nigra Waldst. et Kit, C. azarolus L.) were analysed. Procyanidin B2 (epicatechin-(4 beta-->8)-epicatechin) was isolated from Aesculus hippocastanum fruit shells as reference standard for calibration purposes. The structure elucidation was carried out by by means of MS and 1H-NMR. Quantitative 1H-NMR spectroscopy (qNMR) was applied for purity assessment.

Antioxidants↗

PubMed2001

Allicin release under simulated gastrointestinal conditions from garlic powder tablets employed in clinical trials on serum cholesterol.

The failure of five recent clinical trials to show significant reduction in elevated serum cholesterol by a single brand of allicin-standardized garlic powder tablets is in contrast to many prior positive studies with the same brand. The hypocholesterolemic activity of garlic is mainly due to allicin, a compound that is produced by the acid-sensitive garlic enzyme, alliinase, only after tablet consumption. Therefore, the allicin-releasing ability of ten lots of these tablets--manufactured over the same years that the positive and negative clinical trials were conducted (1989-1997)--was determined under simulated gastrointestinal dissolution conditions, as defined by U.S. Pharmacopeia Method 724A. It was found that the older lots were more resistant to acid-disintegration (2.5 h vs. 1.3 h, P < 0.001) and that they released three times as much allicin (44% vs. 15 % of their potential, P < 0.001) as the newer lots. A second brand of tablets employed in a recent negative trial released no detectable amount of allicin, while a third set of tablets with high allicin release was used in a trial that gave positive effects. Hence, the persons involved in the recent negative clinical trials probably received considerably less allicin than did those in the older positive studies, possibly accounting for much of the discrepancy in the outcomes. In conclusion, clinical trials using garlic powder tablets to assess any effect of garlic that might be related to allicin, as most are, cannot be considered valid for garlic when the trial shows no effect, unless the expected allicin release from the tablets has at least been determined under standardized drug release conditions (USP 724A).

Cholesterol↗

PubMed2004

Induction of growth hormone release by Pueraria thunbergiana BENTH.

Puerariae Radix (PR), Puerariae Flos (PF), and Puerariae Surculus (PS) as well as their constituents were tested for induction of rat growth hormone (rGH) release by both rat pituitary cell culture and in vivo experimentation in order to develop them to novel drugs. Through a calibration curve of the rGH released by addition of rat growth hormone-releasing hormone (rGHRH) to rat pituitary cells, the 70 % ethanol extracts of PR and PS increased rGH release by about 1.6 and 1.7 times as high, respectively, as the control group (264.6 +/- 13.6 pM). However, each puerarin type as a representative constituent of PR in Korea Pharmacopeia (KP) and tectorigenin and an important ingredient of PF were twice as effective as in the control group. The acid hydrolysate of Puerariae Surculus (HPS) increased rGH release concentration-dependently, and its EC (50) was approximately 10.4 microg/ml. The T (max) value for rGH after injection of 20 microg/kg of rGHRH was 10 - 30 min, while the C (max) value was increased by approximately 12-fold compared to the control group (198.2 +/- 25.0 pM) and the AUC (0 - 45) was increased to 10 times the level of the control group (10,840.9 +/- 845.5 min. pM). On the other hand, T (max) for the HPS was 60 min, while C (max) was increased approximately to 5.8 fold compared to control (244.1 +/- 36.4 pM). C (max) for puerarin was 1,028.6 +/- 502.7 pM, that is, approximately 5.2 times as high as the control level. However, tectorigenin (20 microg/kg) was of no statistical significance. Therefore, we suggest that the HPS and puerarin act either on GH secretagogue receptors or on GHRH receptor of somatotrophin as possible agonists or an inhibitor on somatostatin receptor to release rGH, respectively.

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↗

PubMed2003

Atropine availability as an antidote for nerve agent casualties: validated rapid reformulation of high-concentration atropine from bulk powder.

STUDY OBJECTIVE: Atropine is the preferred antidote for immediate management of toxicity associated with nerve agents or other cholinergic syndromes. A large-scale exposure to a nerve agent or organophosphate insecticide might result in many victims presenting for care within a short period of time. This situation would require the prompt availability of a large amount of atropine to provide treatment. Antidote stocks at many hospitals are inadequate to meet this demand. Atropine that is commercially available comes supplied at concentrations of either 0.4 mg/mL or 1 mg/mL, thereby requiring intravenous administration because of the volume necessary to administer the commonly recommended initial dose of 2 to 6 mg. Moderately ill victims may not require an intravenous line for other care, and in the setting of overwhelmed resources, intramuscular administration is faster and easier to perform. METHODS: To facilitate the delivery of larger atropine doses, we developed a method of fortifying existing injectable atropine with bulk pharmaceutical-grade atropine powder to a concentration of 2 mg/mL, thereby increasing the amount available and facilitating its intramuscular administration. An independent analysis of the resulting formulation was undertaken to assess its potency, absence of pyrogens, and stability. RESULTS: The amount of atropine initially present varied by less than +/-5%, within the range allowed by the US Pharmacopeia for the original product. The product was pyrogen free and maintained its potency at refrigeration temperature for at least 8 weeks after preparation and at room temperature for 4 weeks. Once all materials were available, the compounding of this preparation required about 1 hour to complete. CONCLUSION: Existing atropine stocks can be readily augmented by fortification with powdered atropine accurately and inexpensively. Common pharmaceutical guidelines recommend refrigeration for compounded products such as this if not completely used within 28 days.

Adult↗

PubMed1999

Toward an understanding of the biochemical and pharmacological complexity of the saliva of a hematophagous sand fly Lutzomyia longipalpis.

The saliva of blood-sucking arthropods contains powerful pharmacologically active substances and may be a vaccine target against some vector-borne diseases. Subtractive cloning combined with biochemical approaches was used to discover activities in the salivary glands of the hematophagous fly Lutzomyia longipalpis. Sequences of nine full-length cDNA clones were obtained, five of which are possibly associated with blood-meal acquisition, each having cDNA similarity to: (i) the bed bug Cimex lectularius apyrase, (ii) a 5'-nucleotidase/phosphodiesterase, (iii) a hyaluronidase, (iv) a protein containing a carbohydrate-recognition domain (CRD), and (v) a RGD-containing peptide with no significant matches to known proteins in the BLAST databases. Following these findings, we observed that the salivary apyrase activity of L. longipalpis is indeed similar to that of Cimex apyrase in its metal requirements. The predicted isoelectric point of the putative apyrase matches the value found for Lutzomyia salivary apyrase. A 5'-nucleotidase, as well as hyaluronidase activity, was found in the salivary glands, and the CRD-containing cDNA matches the N-terminal sequence of the HPLC-purified salivary anticlotting protein. A cDNA similar to alpha-amylase was discovered and salivary enzymatic activity demonstrated for the first time in a blood-sucking arthropod. Full-length clones were also found coding for three proteins of unknown function matching, respectively, the N-terminal sequence of an abundant salivary protein, having similarity to the CAP superfamily of proteins and the Drosophila yellow protein. Finally, two partial sequences are reported that match possible housekeeping genes. Subtractive cloning will considerably enhance efforts to unravel the salivary pharmacopeia of blood-sucking arthropods.

Amino Acid Sequence↗

PubMed1992

Over-the-counter medications. Do you know what your patients are taking?

The pharmacopeia of over-the-counter (OTC) drugs is ever expanding, and many of these nonprescription agents cause a variety of adverse drug-drug and drug-patient interactions. It is therefore essential that physicians be aware of the more than 700 active ingredients available in OTC drugs at the local store and make a concerted effort to identify which ones their patients are taking. Healthcare providers also need to educate patients about the potential effects of OTC drugs and encourage them to consult either their physician or their pharmacist before attempting self-medication.

Aged↗

PubMedDate not supplied

PLGA microsphere bioburden evaluation for radiosterilization dose selection.

The aim of this study was to determine the bioburden of PLGA microspheres produced by the solvent emulsion/extraction process as a means of determining an appropriate gamma-irradiation dose for sterilization. Bioburden was evaluated on the basis of ISO specifications. The analysis of initial microbial contamination was performed on blank microspheres, prepared by a non-aseptic laboratory scale process. A mean bioburden of 36.04 CFU (colony forming units)/110 mg microspheres was determined. Most of the detected germs originated from human commensal flora. According to the ISO dose-selection method, a gamma-irradiation dose of 19.6 kGy was found sufficient to ensure a sterility level of 10(-6). The effect of the selected irradiation dose on both the molecular weight of the polymer and the kinetics of 5-fluorouracil drug release from the microspheres was compared to the European Pharmacopeia recommended irradiation dose (25 kGy). This 20% reduced dose showed a lower extent of molecular weight reduction of PLGA and a better control of 5-FU release from microparticles. This can be related to reduce polymer radiation damage.

Fluorouracil↗

PubMed1992

Comparison of in vitro and in vivo tests for determination of availability of calcium from calcium carbonate tablets.

In vitro tests of calcium (Ca) availability and the oral Ca load test were conducted on eight brands of calcium carbonate (CaCO3) tablets (products A-H) each providing 500 mg Ca. Data were collected over three experiments with nine to 11 healthy premenopausal women testing two to four products. Subjects followed a low Ca diet (less than 10 mmol/day). On test mornings, fasting subjects collected baseline urine for 2 hours (-2 to 0 hours), then ingested the tablet with water. Urine was collected from 0 to 2 hours and 2 to 4 hours; for products E-H, urine was collected for an additional 2 hours (4 to 6 hours). Blood was sampled at hours 0, 4 and 6 during testing of products E and F. Three in vitro tests were run: the United States Pharmacopeia (USP) dissolution test, USP disintegration test, and a disintegration test using vinegar. Ca excretion rose significantly at hours 2 to 4 (p less than 0.05) compared to baseline for seven products. Ca excretion either fell or remained constant between hours 4 and 6. Serum Ca rose and serum parathyroid hormone fell at hour 4, compared to fasting values, suggesting that 4 hours represents peak response time. In vivo availability, measured as the incremental increase in Ca excretion (mmol/mmol creatinine) in hours 2 to 4 compared to baseline, did not correlate significantly with results of the USP dissolution test but did with results of either the USP disintegration test or the vinegar test.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1995

Dissolution test acceptance sampling plans.

The U.S. Pharmacopeia (USP) general monograph provides a standard for dissolution compliance with the requirements as stated in the individual USP monograph for a tablet or capsule dosage form. The acceptance rules recommended by USP have important roles in the quality control process. The USP rules and their modifications are often used as an industrial lot release sampling plan, where a lot is accepted when the tablets or capsules sampled are accepted as proof of compliance with the requirement. In this paper, the operating characteristics of the USP acceptance rules are reviewed and compared to a selected modification. The operating characteristics curves show that the USP acceptance rules are sensitive to the true mean dissolution and do not reject a lot or batch that has a large percentage of tablets that dissolve with less than the dissolution specification.

Capsules↗

PubMed1997

Statistical comparison between dissolution profiles of drug products.

The problem for assessment of similarity between dissolution profiles of two drug products is considered. The commonly used classical methods including model-dependent and model-independent approaches are reviewed. Most methods encountered the difficulties of no well-defined equivalence limits and the correlation between consecutive time points. Several methods have been proposed to account for these difficulties, e.g., the method of repeated measures (1) and the multivariate analysis approach (2). These methods, however, are sensitive to the selection of time points and complex covariance error structure. In this paper, we propose equivalence limits for similarity based on the amount of dissolved active ingredient as specified in the United States Pharmacopeia and National Formulary (USP/NF). Accordingly, we proposed a time series approach, which accounts for correlation between dissolution results at different time points. The proposed model is shown to be useful in assessment of similarity between dissolution profiles of two drug products. An example concerning dissolution testing of two lots of a drug product is used to illustrate the proposed equivalence limits and statistical methodology.

Analysis of Variance↗

PubMed2006

The influence of granulation on super disintegrant performance.

The purpose of this study is to identify the causes of efficiency loss of super disintegrants following granulation or reworking. Two processes, precompression and prewetting, were proposed to simulate the processes during dry and wet granulation, respectively. The disintegration efficiency of the resulting disintegrant granules was tested in model formulations composed of dicalcium phosphate and lactose with the unprocessed disintegrants as controls. No significant difference was shown in the intrinsic swelling and the water uptake abilities of all super disintegrants following dry granulation. However, a significant decrease was observed for both Primojel and Polyplasdone XL10 in the rate of water being absorbed into the tablet matrix following wet granulation, but not for Ac-Di-Sol. United States Pharmacopeia (USP) disintegration testing without disc revealed a significant increase in disintegration time for tablets formulated with dry granulated Primojel and Polyplasdone XL10 and all wet granulated disintegrants. The increase in particle size following granulation appears to be the cause of the loss in disintegration efficiency. In conclusion, Ac-Di-Sol is less affected by both precompression and prewetting. The efficiency of Primojel and Polyplasdone XL10 is highly dependent on their particle size. Descreasing the particle size tends to increase their efficiency. Due to the size increase following granulation, a higher addition level of super disintegrant is required to ensure fast and uniform disintegration of tablets prepared by granulation.

Chemistry, Pharmaceutical↗

PubMed2006

The importance of the cosolvent propylene glycol on the antimicrobial preservative efficacy of a pharmaceutical formulation by DOE-ruggedness testing.

The aim of this study was to statistically evaluate the influence of the concentration of the co-solvent propylene glycol on the preservative efficacy of a complex pharmaceutical suspension-emulsion formulation containing methyl- and propylparaben. Preservative Efficacy Tests (PETs) were performed using the validated pharmacopoeial methodology with five test organisms over 1 month on lab-scale test formulations. These were independently prepared according to a Box-Behnken experimental design with a triplicate central point at 0.22% m/m methylparaben, 0.22% m/m propylparaben, and 2.75% m/m propylene glycol, and with an additional corner point of the Box-Behnken cube. We evaluated the preservative efficacies against the criteria of the United States Pharmacopeia (USP) and European Pharmacopoeias (PhEur) for formulations for oral use, as well as by the statistical comparison of the slopes obtained by linear regression of log (CFU/g) vs. time. With an initial bacterial challenge of 10(6) CFU/g for each of the three bacterial strains, no survivals were detected after 7 days. For the two fungal strains, box plots and analysis of variance showed significant, concentration-dependent, main effects: the three variables significantly influenced the kill-rate of C. albicans, while A. niger was predominantly influenced by the cosolvent propylene glycol, and only to a minor extent by methylparaben and not at all by propylparaben. These findings were confirmed by taking the pharmacopoeial criteria as the evaluation basis, where the dominant influence of propylene glycol concentration is apparent. It was concluded that the cosolvent propylene glycol is at least of equal preservative importance than both parabens.

Anti-Infective Agents↗

PubMed2001

Final report on the safety assessment of Peanut (Arachis hypogaea) Oil, Hydrogenated Peanut Oil, Peanut Acid, Peanut Glycerides, and Peanut (Arachis hypogaea) Flour.

Peanut (Arachis Hypogaea) Oil is the refined fixed oil obtained from the seed kernels of Arachis hypogaea. Hydrogenated Peanut Oil, Peanut Acid, and Peanut Glycerides are all derived from Peanut Oil. Peanut Flour is a powder obtained by the grinding of peanuts. The oils and glycerides function in cosmetic formulations as skin-conditioning agents. The acid functions as a surfactant-cleansing agent, and the flour functions as an abrasive, bulking agent and/or viscosity-increasing agent. In 1998, only Peanut Oil and Hydrogenated Peanut Oil were reported in use. When applied to the skin, Peanut Oil can enhance the absorption of other compounds. Hepatic changes were noted at microscopic examination of rats fed diets containing 15% edible Peanut Oil for 28 days, although no control group was maintained and the findings were also noted in rats fed fresh corn oil. United States Pharmacopeia (USP)-grade Peanut Oil was considered relatively nonirritating when injected into guinea pigs and monkeys. Technical-grade Peanut Oil was moderately irritating to rabbits and guinea pigs and mildly irritating to rats following dermal exposure. This same oil produced reactions in < or = 10% of 50 human males. Peanut Oil was not an ocular irritant in rabbits. Peanut Oil, either "laboratory expressed" or extracted using a food-grade solvent, was not carcinogenic to mice. Peanut Oil exerted anticarcinogenic activity when tested against known carcinogens. Peanuts are the food most likely to produce allergic and anaphylactic reactions. The major allergen is a protein that does not partition into Peanut Oil, Hydrogenated Peanut Oil, Peanut Acid, and Peanut Glycerides. Aflatoxins can be produced in stored agricultural crops such as peanuts, but do not partition into the oils, acids, or glycerides. Manufacturers were cautioned to make certain that the oils, acids, and glycerides are free of aflatoxins and protein. Formulators were cautioned that the oils, acids, or glycerides may enhance penetration and can affect the use of other ingredients whose safety assessment was based on their lack of absorption. The available studies on Peanut Oil supported the conclusion that Peanut Oil, Hydrogenated Peanut Oil, Peanut Acid, and Peanut Glycerides are safe for use in cosmetic formulations. Peanut (Arachis Hypogaea) Flour, however, is sufficiently different from the above ingredients such that its safety can not be supported by studies using the oil. The additional data needed for Peanut (Arachis Hypogaea) Flour are (1) concentration of use; (2) chemical specifications (i.e., aflatoxin and protein levels); (3) method of preparation; and (4) contact urticaria and dermal sensitization at concentration of use. Although data on aflatoxin levels are sought, it is expected that concentrations of aflatoxin should comply with U.S. government stipulations. Absent the additional data, it was concluded that the available data are insufficient to support the safety of Peanut (Arachis Hypogaea) Flour for use in cosmetic products.

Administration, Cutaneous↗