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Test Products (test + products)
Selected AbstractsCaries clinical trial of a remineralising toothpaste in radiation patientsGERODONTOLOGY, Issue 2 2008Athena Papas Objectives:, The purpose of this study was to determine the efficacy and safety of a specially formulated remineralising toothpaste in controlling caries in a high-risk population: head and neck radiation patients. Design:, The study compared the performance of the remineralising toothpaste with a conventional fluoride dentifrice using double-blind randomisation. Materials and methods:,Test products: The products compared contained equivalent quantities of fluoride (1100 p.p.m.). The dual-phase remineralising toothpaste, Enamelon®, also delivered soluble calcium and phosphate ions, essential components of teeth, from separate phases. Both groups had all caries restored at baseline and used a fluoride rinse daily. Subjects: Fifty-seven subjects who received radiation to the head and neck causing saliva hypofunction, entered the study, while 44 completed the 10,12 month visit. Measurements: Examinations included coronal and root caries using the Pitts Diagnostic Criteria, salivary flow rate, plaque and gingival indices and microbiological counts over a 1-year period. Results:, The average net increment per year for root caries per subject was 0.04 (±.052) in subjects completing the study using the remineralising toothpaste and 1.65 (±0.51) for root caries in subjects completing the study using the conventional fluoride dentifrice. The difference was statistically significant (p = 0.03), suggesting lower net root surface increment/year for the remineralising toothpaste relative to the conventional toothpaste. No significant differences were noted on coronal surfaces. Conclusion:, The results indicate that the remineralising toothpaste provides a significant benefit in preventing and remineralising root caries in high-risk patients. [source] N-Palmitoyl-4-Hydroxy- L -Proline Palmityl Ester: A Pseudoceramide that Provides Efficient Skin Barrier Repair and ProtectionINTERNATIONAL JOURNAL OF COSMETIC SCIENCE, Issue 1 2006G. Vielhaber Ceramides are the main constituents of the epidermal permeability barrier, and it has been demonstrated that the application of ceramide enriched creams promotes epidermal barrier repair. However, nature-identical ceramides are extremely expensive and difficult to formulate. We therefore developed a new pseudoceramide, N-palmitoyl-4-hydroxy- l -proline palmityl ester (BIO391). Due to its low melting point of £60°C the pseudoceramide BIO391 can easily be incorporated into cosmetic formulations. In addition, it is very safe for use in cosmetics. The efficacy of the pseudoceramide BIO391 was investigated in vivo in a model for detergent-induced barrier disruption. Trans-epidermal water loss, redness, and skin hydration were recorded before and after barrier disruption as well as during the subsequent 9-day treatment with the test products. Barrier repair of skin treated with the pseudoceramide BIO391 was accomplished earlier than that of untreated and vehicle treated skin. Optimum barrier repair was achieved with 1.0% pseudoceramide BIO391 and optimum erythema reduction with 0.5% pseudoceramide BIO391. The optimum dosage could be reduced to 0.1% pseudo-ceramide by synergistic combination with 0.1% (-)-a-bisabolol. In addition, the pseudoceramide BIO391 proved to be as effective as nature-identical ceramides 2 and 3. In summary, N-palmitoyl-4-hydroxy- l -proline palmityl ester is a highly efficient barrier repair agent with efficacy equivalent to that of nature-identical ceramides, and it has excellent formulation properties. [source] EVALUATION OF ISOMALT AND HYDROGENATED STARCH HYDROLYSATE IN SUGARLESS CARAMEL POPCORN,JOURNAL OF FOOD QUALITY, Issue 1 2002L.G. BECK Five formulations of sugarless caramel popcorn sweetened with different proportions of hydrogenated starch hydrolysate and isomalt were developed. Control and test products were evaluated for changes in physical, chemical and sensory properties over a 3-month storage period at 33C and 50% humidity. Moisture content and water activity values increased for all products, but color values did not change with time. Texture compressibility measurements were highly correlated with liking of texture values gathered from a consumer study. The fonnula with 100percnt; isomalt was liked significantly more by consumers than the other formulas. [source] Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate,,JOURNAL OF PHARMACEUTICAL SCIENCES, Issue 4 2010E. Jantratid Abstract Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing doxycycline hyclate are reviewed. According to the Biopharmaceutics Classification System (BCS), doxycycline hyclate can be assigned to BCS Class I. No problems with BE of IR doxycycline formulations containing different excipients and produced by different manufacturing methods have been reported and hence the risk of bioinequivalence caused by these factors appears to be low. Doxycycline has a wide therapeutic index. Further, BCS-based dissolution methods have been shown to be capable of identifying formulations which may dissolve too slowly to generate therapeutic levels. It is concluded that a biowaiver is appropriate for IR solid oral dosage forms containing doxycycline hyclate as the single Active Pharmaceutical Ingredient (API) provided that (a) the test product contains only excipients present in doxycycline hyclate IR solid oral drug products approved in the International Conference on Harmonization (ICH) or associated countries; and (b) the comparator and the test products comply with the BCS criteria for "very rapidly dissolving" or, alternatively, when similarity of the dissolution profiles can be demonstrated and the two products are "rapidly dissolving.". © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99: 1639,1653, 2010 [source] | |||||||||||||