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Nigel K.h. Slater - One of the best experts on this subject based on the ideXlab platform.

  • drug and nutrient administration on the nicu is delivery during breastfeeding an alternative to oral syringes
    Journal of Neonatal Nursing, 2020
    Co-Authors: Theresa Maier, Nigel K.h. Slater, Oliver Bonner, Paula Peirce, Kathryn Beardsall
    Abstract:

    Abstract Objective This study explored the attitudes of parents and nurses regarding the concept of therapeutic delivery from a Nipple Shield in a high-resource environment, and identified associated benefits, risks, and design preferences. Design Semi-structured interviews were conducted with seven fathers, twelve mothers, and nine registered nurses on a UK level 3 Neonatal Intensive and a Transitional Care Unit. Results All participants responded positively to the concept of therapeutic delivery from a Nipple Shield during breastfeeding. It was perceived as particularly beneficial in neonatal intensive care, empowering mothers to assume responsibility of their infant's health, and fostering mother-infant bonding. Highlighted potential risks included association of breastfeeding with adverse therapeutic taste, or incomplete therapeutic delivery. A commercial Nipple Shield was preferred over modified Shields. Conclusions This study shows the potential benefits of alternative methods for infant oral therapeutic delivery, and that administration during breastfeeding could be a potential solution.

  • iron delivery from liquid core hydrogels within a therapeutic Nipple Shield
    European Journal of Pharmaceutical Sciences, 2019
    Co-Authors: Theresa Maier, Ljiljana Fruk, Antonina Kerbs, Nigel K.h. Slater
    Abstract:

    Abstract To aid oral therapeutic administration to infants, a novel delivery technology, referred to as a Therapeutic Nipple Shield (TNS), was previously developed. It consists of a silicone Nipple Shield device and a dosage form containing a therapeutic (or Active Pharmaceutical Ingredient (API)) to enable delivery during breastfeeding. A range of dosage forms were investigated in past literature, but sufficient API release into human milk had not been achieved. The presented work illustrates the delivery of iron sulphate pentahydrate from liquid-core sodium alginate hydrogels, inserted into a commercially available ultra-thin silicone Nipple Shield into human milk during in-vitro breastfeeding simulation. Release of iron was quantified employing absorbance measurements of a salicylic assay. An absolute recovery of 44.35 ± 5.43% of loaded iron(III)sulphate pentahydrate was obtained after 10.58 ± 0.09 g of human milk had passed through the Nipple Shield. This finding is superior to previous investigations involving the delivery of zinc from rapidly disintegrating tablets and non-woven fibres within a TNS. Due to their superior delivery properties, ease of fabrication and cost-efficiency, liquid-core sodium alginate hydrogels consequently represent a promising dosage form for use as part of the TNS. Further improvements can be made to enhance handling stability and shelf-life characteristics.

  • Zinc delivery from non-woven fibres within a therapeutic Nipple Shield.
    International Journal of Pharmaceutics, 2018
    Co-Authors: Theresa Maier, Rebekah L Scheuerle, Daniel Markl, Sylvaine F. A. Bruggraber, Axel Zeitler, Ljiljana Fruk, Nigel K.h. Slater
    Abstract:

    Abstract A Therapeutic Nipple Shield (TNS) was previously developed to respond to the global need for new infant therapeutic delivery technologies. However, the release efficiency for the same Active Pharmaceutical Ingredient (API) from different therapeutic matrices within the TNS formulation has not yet been investigated. To address this, in-vitro release of elemental zinc into human milk from two types of Texel non-woven fibre mats of varying thickness and different gram per square meter values, placed inside the TNS was explored and compared to the release from zinc-containing rapidly disintegrating tablets. In-vitro delivery was performed by means of a breastfeeding simulation apparatus, with human milk flow rates and suction pressure adjusted to physiologically relevant values, and release was quantified using Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). It was found that a total recovery of 62–64 % elemental zinc was obtained after the human milk had passed through the fibre insert, amounting to a 20–48% increase compared to previous zinc delivery studies using rapidly disintegrating tablets within the TNS. This indicates that non-woven Texel fibre mats were identified as the superior dosage form for oral zinc delivery into human milk using a TNS.

  • Using the Slug Mucosal Irritation Assay to Investigate the Tolerability of Tablet Excipients on Human Skin in the Context of the Use of a Nipple Shield Delivery System
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Rebekah L Scheuerle, Nigel K.h. Slater, Stephen Gerrard, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Methods Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Results Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. Conclusion These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form

Catherine Tuleu - One of the best experts on this subject based on the ideXlab platform.

  • Using the Slug Mucosal Irritation Assay to Investigate the Tolerability of Tablet Excipients on Human Skin in the Context of the Use of a Nipple Shield Delivery System
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Rebekah L Scheuerle, Nigel K.h. Slater, Stephen Gerrard, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Methods Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Results Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. Conclusion These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  • characterisation of zinc delivery from a Nipple Shield delivery system using a breastfeeding simulation apparatus
    PLOS ONE, 2017
    Co-Authors: Rebekah L Scheuerle, Catherine Tuleu, Richard Kendall, Stephen E Gerrard, Sylvaine F. A. Bruggraber, Nigel K.h. Slater
    Abstract:

    Zinc delivery from a Nipple Shield delivery system (NSDS), a novel platform for administering medicines to infants during breastfeeding, was characterised using a breastfeeding simulation apparatus. In this study, human milk at flow rates and pressures physiologically representative of breastfeeding passed through the NSDS loaded with zinc-containing rapidly disintegrating tablets, resulting in release of zinc into the milk. Inductively coupled plasma optical emission spectrometry was used to detect the zinc released, using a method that does not require prior digestion of the samples and that could be applied in other zinc analysis studies in breast milk. Four different types of zinc-containing tablets with equal zinc load but varying excipient compositions were tested in the NSDS in vitro. Zinc release measured over 20 minutes ranged from 32-51% of the loaded dose. Total zinc release for sets tablets of the same composition but differing hardness were not significantly different from one another with P = 0.3598 and P = 0.1270 for two tested pairs using unpaired t tests with Welch's correction. By the same test total zinc release from two sets of tablets having similar hardness but differing composition were also not significantly significant with P = 0.2634. Future zinc tablet composition and formulation optimisation could lead to zinc supplements and therapeutics with faster drug release, which could be administered with the NSDS during breastfeeding. The use of the NSDS to deliver zinc could then lead to treatment and prevention of some of the leading causes of child mortality, including diarrheal disease and pneumonia.

  • modeling the physiological factors that affect drug delivery from a Nipple Shield delivery system to breastfeeding infants
    Journal of Pharmaceutical Sciences, 2013
    Co-Authors: Stephen E Gerrard, Mine Orlugul, Catherine Tuleu, Nigel K.h. Slater
    Abstract:

    An apparatus was designed to mimic lactation from a human breast. It was used to determine the influence of milk fat content and flow rate, and suction pulse rate of a breastfeeding infant upon the release of a model compound from a Nipple Shield delivery system (NSDS). The NSDS would be worn by a mother to deliver drugs and nutrients to her infant during breastfeeding. Sulforhodamine B dye (SB) was used as model compound and formulated as a dispersible tablet to be placed within the NSDS. Increasing suction pulse rate from 30 to 120 pulses/min clearly correlated with increased cumulative release of SB for the same volume of milk passed through the NSDS. No distinct correlation was found between flow rates (1, 5, and 8 mL/min) and SB release, possibly because of competing factors controlling release rate at different flow rates. A highly similar SB release rate into two fat content fluids (2.9 and 4.2 wt %) was observed for identical flow conditions. This proof of concept study outlines a novel method to mimic lactation from a breast, and future studies will lead to effective methods to identify key physiological factors that influence drug release from a NSDS. C

Stephen E Gerrard - One of the best experts on this subject based on the ideXlab platform.

  • community feedback on the justmilk Nipple Shield delivery system in the vhembe district of limpopo province south africa
    South African Journal of Child Health, 2017
    Co-Authors: Aspen Flynn, Stephen E Gerrard, Rebekah L Scheuerle, Geoff Galgon, Vhonani Netshandama
    Abstract:

    Background Infant medication administration is a major public health challenge, especially in rural or low-resource areas. The JustMilk Nipple Shield Delivery System (NSDS) is a novel method of infant medication delivery designed to address some of these challenges. Objective The purpose of this study was to explore the acceptability of the JustMilk NSDS in selected communities in the Vhembe District of Limpopo, South Africa. Methods Data was collected through 39 semi-structured interviews with infant caretakers and health workers in the Vhembe District. Interviews were transcribed and coded into themes, which were verified by an independent coder. Results Four themes arose around acceptability of the JustMilk NSDS: input on device design, perceived benefits of the device, perceived barriers to community acceptance, and suggested device applications. Participants expressed positivity about the NSDS concept. Potential for increased dosing accuracy was stated as the main positive attribute of the NSDS. Potential stigma was noted, and the need for an education program about the device was discussed. No major community barriers to NSDS use were noted. Acetaminophen and de-worming agents were suggested as potential applications for the device. Conclusion Participants were enthusiastic about the potential benefits of the NSDS and were interested in using the device to deliver medication to infants. Design suggestions, especially to combat potential stigma of device use, will be thoroughly considered by the researchers. This study was a positive step forward in developing the NSDS as a novel method of medication delivery to breastfeeding infants, particularly in rural or low-resource areas.

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  • characterisation of zinc delivery from a Nipple Shield delivery system using a breastfeeding simulation apparatus
    PLOS ONE, 2017
    Co-Authors: Rebekah L Scheuerle, Catherine Tuleu, Richard Kendall, Stephen E Gerrard, Sylvaine F. A. Bruggraber, Nigel K.h. Slater
    Abstract:

    Zinc delivery from a Nipple Shield delivery system (NSDS), a novel platform for administering medicines to infants during breastfeeding, was characterised using a breastfeeding simulation apparatus. In this study, human milk at flow rates and pressures physiologically representative of breastfeeding passed through the NSDS loaded with zinc-containing rapidly disintegrating tablets, resulting in release of zinc into the milk. Inductively coupled plasma optical emission spectrometry was used to detect the zinc released, using a method that does not require prior digestion of the samples and that could be applied in other zinc analysis studies in breast milk. Four different types of zinc-containing tablets with equal zinc load but varying excipient compositions were tested in the NSDS in vitro. Zinc release measured over 20 minutes ranged from 32-51% of the loaded dose. Total zinc release for sets tablets of the same composition but differing hardness were not significantly different from one another with P = 0.3598 and P = 0.1270 for two tested pairs using unpaired t tests with Welch's correction. By the same test total zinc release from two sets of tablets having similar hardness but differing composition were also not significantly significant with P = 0.2634. Future zinc tablet composition and formulation optimisation could lead to zinc supplements and therapeutics with faster drug release, which could be administered with the NSDS during breastfeeding. The use of the NSDS to deliver zinc could then lead to treatment and prevention of some of the leading causes of child mortality, including diarrheal disease and pneumonia.

  • acceptability of a Nipple Shield delivery system administering antiviral agents to prevent mother to child transmission of hiv through breastfeeding
    Journal of Human Lactation, 2015
    Co-Authors: Catherine Hart, Stephen E Gerrard, Kiersten Israelballard, Carol L Joanis, Mary Lynn Baniecki, Florence Thungu, Elizabeth Kneen, David C Sokal
    Abstract:

    Background:Breastfeeding is a route of mother-to-child transmission (MTCT) of the human immunodeficiency virus (HIV). The World Health Organization recommends antiretroviral (ARV) prophylaxis as the best method to prevent mother-to-child transmission of HIV (PMTCT) during breastfeeding. The Nipple Shield delivery system (NSDS) is being developed as an accessible method to deliver ARVs to infants and PMTCT during breastfeeding. The NSDS can potentially circumvent hygiene and storage issues in delivering drugs to infants in low-resource settings.Objectives:The primary objective was to determine acceptability of the NSDS for PMTCT in Kenya. Secondary objectives included assessing mothers’ understanding of MTCT and identifying cultural and implementation issues that might affect NSDS acceptability.Methods:Eleven focus group discussions were conducted, each group consisting of 7 to 12 participants. Seven focus group discussions consisted of HIV-positive mothers, 2 included grandmothers/mothers-in-law, and 2 in...

Rebekah L Scheuerle - One of the best experts on this subject based on the ideXlab platform.

  • Zinc delivery from non-woven fibres within a therapeutic Nipple Shield.
    International Journal of Pharmaceutics, 2018
    Co-Authors: Theresa Maier, Rebekah L Scheuerle, Daniel Markl, Sylvaine F. A. Bruggraber, Axel Zeitler, Ljiljana Fruk, Nigel K.h. Slater
    Abstract:

    Abstract A Therapeutic Nipple Shield (TNS) was previously developed to respond to the global need for new infant therapeutic delivery technologies. However, the release efficiency for the same Active Pharmaceutical Ingredient (API) from different therapeutic matrices within the TNS formulation has not yet been investigated. To address this, in-vitro release of elemental zinc into human milk from two types of Texel non-woven fibre mats of varying thickness and different gram per square meter values, placed inside the TNS was explored and compared to the release from zinc-containing rapidly disintegrating tablets. In-vitro delivery was performed by means of a breastfeeding simulation apparatus, with human milk flow rates and suction pressure adjusted to physiologically relevant values, and release was quantified using Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). It was found that a total recovery of 62–64 % elemental zinc was obtained after the human milk had passed through the fibre insert, amounting to a 20–48% increase compared to previous zinc delivery studies using rapidly disintegrating tablets within the TNS. This indicates that non-woven Texel fibre mats were identified as the superior dosage form for oral zinc delivery into human milk using a TNS.

  • community feedback on the justmilk Nipple Shield delivery system in the vhembe district of limpopo province south africa
    South African Journal of Child Health, 2017
    Co-Authors: Aspen Flynn, Stephen E Gerrard, Rebekah L Scheuerle, Geoff Galgon, Vhonani Netshandama
    Abstract:

    Background Infant medication administration is a major public health challenge, especially in rural or low-resource areas. The JustMilk Nipple Shield Delivery System (NSDS) is a novel method of infant medication delivery designed to address some of these challenges. Objective The purpose of this study was to explore the acceptability of the JustMilk NSDS in selected communities in the Vhembe District of Limpopo, South Africa. Methods Data was collected through 39 semi-structured interviews with infant caretakers and health workers in the Vhembe District. Interviews were transcribed and coded into themes, which were verified by an independent coder. Results Four themes arose around acceptability of the JustMilk NSDS: input on device design, perceived benefits of the device, perceived barriers to community acceptance, and suggested device applications. Participants expressed positivity about the NSDS concept. Potential for increased dosing accuracy was stated as the main positive attribute of the NSDS. Potential stigma was noted, and the need for an education program about the device was discussed. No major community barriers to NSDS use were noted. Acetaminophen and de-worming agents were suggested as potential applications for the device. Conclusion Participants were enthusiastic about the potential benefits of the NSDS and were interested in using the device to deliver medication to infants. Design suggestions, especially to combat potential stigma of device use, will be thoroughly considered by the researchers. This study was a positive step forward in developing the NSDS as a novel method of medication delivery to breastfeeding infants, particularly in rural or low-resource areas.

  • Using the Slug Mucosal Irritation Assay to Investigate the Tolerability of Tablet Excipients on Human Skin in the Context of the Use of a Nipple Shield Delivery System
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Rebekah L Scheuerle, Nigel K.h. Slater, Stephen Gerrard, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Methods Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Results Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. Conclusion These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

Richard Kendall - One of the best experts on this subject based on the ideXlab platform.

  • Using the Slug Mucosal Irritation Assay to Investigate the Tolerability of Tablet Excipients on Human Skin in the Context of the Use of a Nipple Shield Delivery System
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Rebekah L Scheuerle, Nigel K.h. Slater, Stephen Gerrard, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Methods Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Results Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. Conclusion These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Purpose Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form

  • using the slug mucosal irritation assay to investigate the tolerability of tablet excipients on human skin in the context of the use of a Nipple Shield delivery system
    Pharmaceutical Research, 2017
    Co-Authors: Richard Kendall, Joke Lenoir, Stephen E Gerrard, Rebekah L Scheuerle, Nigel K.h. Slater, Catherine Tuleu
    Abstract:

    Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified Nipple Shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological Nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the Nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]. Slugs were exposed to blends slurried in human breast milk to assess their stinging, itching or burning potential, using objective values such as mucus production to categorize irritation potency Presently an in vivo assay, previously validated for prediction of ocular and nasal irritation, was used as an alternative to vertebrate models to anticipate the potential maternal dermatological tolerability issues to NSDS tablet components. The excipients did not elicit irritancy. However, mild irritancy was observed when zinc sulphate was present in blends. These promising good tolerability results support the continued investigation of these excipients within NSDS rapidly disintegrating tablet formulations. Topical local tolerance effects being almost entirely limited to irritation, the slug assay potentially adds to the existing preformulation toolbox, and may sit in between the in vitro and existing in vivo assays.

  • characterisation of zinc delivery from a Nipple Shield delivery system using a breastfeeding simulation apparatus
    PLOS ONE, 2017
    Co-Authors: Rebekah L Scheuerle, Catherine Tuleu, Richard Kendall, Stephen E Gerrard, Sylvaine F. A. Bruggraber, Nigel K.h. Slater
    Abstract:

    Zinc delivery from a Nipple Shield delivery system (NSDS), a novel platform for administering medicines to infants during breastfeeding, was characterised using a breastfeeding simulation apparatus. In this study, human milk at flow rates and pressures physiologically representative of breastfeeding passed through the NSDS loaded with zinc-containing rapidly disintegrating tablets, resulting in release of zinc into the milk. Inductively coupled plasma optical emission spectrometry was used to detect the zinc released, using a method that does not require prior digestion of the samples and that could be applied in other zinc analysis studies in breast milk. Four different types of zinc-containing tablets with equal zinc load but varying excipient compositions were tested in the NSDS in vitro. Zinc release measured over 20 minutes ranged from 32-51% of the loaded dose. Total zinc release for sets tablets of the same composition but differing hardness were not significantly different from one another with P = 0.3598 and P = 0.1270 for two tested pairs using unpaired t tests with Welch's correction. By the same test total zinc release from two sets of tablets having similar hardness but differing composition were also not significantly significant with P = 0.2634. Future zinc tablet composition and formulation optimisation could lead to zinc supplements and therapeutics with faster drug release, which could be administered with the NSDS during breastfeeding. The use of the NSDS to deliver zinc could then lead to treatment and prevention of some of the leading causes of child mortality, including diarrheal disease and pneumonia.