Impact of seam on liquid transmission behaviour of multi-layered ensembles using sweat and water

457-463Present study is focussed on the effect of seam on the moisture transmission in liquid form. Behaviour of actual sweat is found to be different from pure water used while evaluating the performance of multilayer clothing systems in seamed and unseamed condition in terms of their in-plane (wetting time) & cross-plane moisture transmission and overall moisture management capacity. Uni-directional seam shows higher wetting time at the inner surface as well as better cross-plane transmittance, and hence better overall moisture management capacity as compared to bi-directional stitched and unseamed fabrics. In all the cases, sweat shows less wetting time than water. Multi-layered ensemble with polyester spacer fabric as middle layer exhibits better overall moisture management properties in comparison to layered ensemble with fleece fabric as middle layer both in seamed and unseamed conditions. Seam type plays a most significant role followed by type of layered ensembles then solution type in affecting the overall moisture management behaviour of seamed ensembles

Impact of seam on liquid transmission behaviour of multi-layered ensembles using sweat and water

Present study is focussed on the effect of seam on the moisture transmission in liquid form. Behaviour of actual sweat is found to be different from pure water used while evaluating the performance of multilayer clothing systems in seamed and unseamed condition in terms of their in-plane (wetting time) & cross-plane moisture transmission and overall moisture management capacity. Uni-directional seam shows higher wetting time at the inner surface as well as better cross-plane transmittance, and hence better overall moisture management capacity as compared to bi-directional stitched and unseamed fabrics. In all the cases, sweat shows less wetting time than water. Multi-layered ensemble with polyester spacer fabric as middle layer exhibits better overall moisture management properties in comparison to layered ensemble with fleece fabric as middle layer both in seamed and unseamed conditions. Seam type plays a most significant role followed by type of layered ensembles then solution type in affecting the overall moisture management behaviour of seamed ensembles

Impact of varying lactate concentration in sweat on liquid moisture transmission behaviour of layered ensembles

The present study is focussed on the impact of change in the lactate concentration (43 mM and 22 mM) in sweat solution on liquid moisture transmission behaviour through the clothing. The sweat solution with higher concentration of lactate (43 mM) shows delayed wetting at the top surface both in case of individual layer and multi-layer fabric ensembles, i.e. it takes longer time to wet the top surface in spite of the lower contact angle made by it. Significant difference is observed in in-plane transmission behaviour of both the sweat solutions in the case of multi-layered ensembles. In case of multi-layered ensembles, wetting time reduces drastically, even though both the ensembles consist of polyester knit as the inner surface possessing wetting time is 50 s approximately. Sweat solution with higher lactate concentration also shows higher cross-planar transmission rate as compared to in-plane transmission. Uni-directional seamed multi-layered spacer fabric exhibits better overall moisture management coefficient as compared to bi-directional seamed spacer ensembles with sweat solution containing higher lactate concentration. Middle layer also plays a vital role in altering the overall liquid moisture transmission behaviour

Biowaiver monographs for immediate release solid oral dosage forms: prednisolone.

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 prednisolone are reviewed. Data on its solubility, oral absorption, and permeability are not totally conclusive, but strongly suggest a BCS Class 1 classification. Prednisolone's therapeutic indications and therapeutic index, pharmacokinetics, and the possibility of excipient interactions were also taken into consideration. Available evidence indicates that a biowaiver for IR solid oral dosage forms formulated with the excipients tabulated in this article would be unlikely to expose patients to undue risks

Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol).

Literature data are reviewed on the properties of acetaminophen (paracetamol) related to the biopharmaceutics classification system (BCS). According to the current BCS criteria, acetaminophen is BCS Class III compound. Differences in composition seldom, if ever, have an effect on the extent of absorption. However, some studies show differences in rate of absorption between brands and formulations. In particular, sodium bicarbonate, present in some drug products, was reported to give an increase in the rate of absorption, probably caused by an effect on gastric emptying. In view of Marketing Authorizations (MAs) given in a number of countries to acetaminophen drug products with rapid onset of action, it is concluded that differences in rate of absorption were considered therapeutically not relevant by the Health Authorities. Moreover, in view of its therapeutic use, its wide therapeutic index and its uncomplicated pharmacokinetic properties, in vitro dissolution data collected according to the relevant Guidances can be safely used for declaring bioequivalence (BE) of two acetaminophen formulations. Therefore, accepting a biowaiver for immediate release (IR) acetaminophen solid oral drug products is considered scientifically justified, if the test product contains only those excipients reported in this paper in their usual amounts and the test product is rapidly dissolving, as well as the test product fulfils the criterion of similarity of dissolution profiles to the reference product

Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate

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 bio in equivalence 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, 2010Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/64911/1/21954_ftp.pd

Biowaiver monographs for immediate release solid oral dosage forms: Aciclovir

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed. Aciclovir therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) studies were also taken into consideration in order to ascertain whether a biowaiver can be recommended. According to the Biopharmaceutics Classification System (BCS) and considering tablet strengths up to 400 mg, aciclovir would be BCS Class III. However, in some countries also 800 mg tablets are available which fall just within BCS Class IV. Aciclovir seems not to be critical with respect to a risk for bio in equivalence, as no examples of bio in equivalence have been identified. It has a wide therapeutic index and is not used for critical indications. Hence, if: (a) the test product contains only excipients present in aciclovir solid oral IR drug products approved in ICH or associated countries, for instance as presented in this article; and (b) the comparator and the test product both are very rapidly dissolving , a biowaiver for IR aciclovir solid oral drug products is considered justified for all tablet strengths. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:5061–5073, 2008Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/61316/1/21392_ftp.pd

Controlling particle size in the Stöber process and incorporation of calcium

The Stӧber process is commonly used for synthesising spherical silica particles. This article reports the first comprehensive study of how the process variables can be used to obtain monodispersed particles of specific size. The modal particle size could be selected within in the range 20 – 500 nm. There is great therapeutic potential for bioactive glass nanoparticles, as they can be internalised within cells and perform sustained delivery of active ions. Biodegradable bioactive glass nanoparticles are also used in nanocomposites. Modification of the Stӧber process so that the particles can contain cations such as calcium, while maintaining monodispersity, is desirable. Here, while calcium incorporation is achieved, with a homogenous distribution, careful characterisation shows that much of the calcium is not incorporated. A maximum of 10 mol% CaO can be achieved and previous reports are likely to have overestimated the amount of calcium incorporated

MycoRRdb: A Database of Computationally Identified Regulatory Regions within Intergenic Sequences in Mycobacterial Genomes

The identification of regulatory regions for a gene is an important step towards deciphering the gene regulation. Regulatory regions tend to be conserved under evolution that facilitates the application of comparative genomics to identify such regions. The present study is an attempt to make use of this attribute to identify regulatory regions in the Mycobacterium species followed by the development of a database, MycoRRdb. It consist the regulatory regions identified within the intergenic distances of 25 mycobacterial species. MycoRRdb allows to retrieve the identified intergenic regulatory elements in the mycobacterial genomes. In addition to the predicted motifs, it also allows user to retrieve the Reciprocal Best BLAST Hits across the mycobacterial genomes. It is a useful resource to understand the transcriptional regulatory mechanism of mycobacterial species. This database is first of its kind which specifically addresses cis-regulatory regions and also comprehensive to the mycobacterial species. Database URL: http://mycorrdb.uohbif.in