Maternal psychological risk and the neural correlates of infant face processing: A latent profile analysis.

Maternal psychological factors, including anxiety, depression, and substance use, may negatively affect parenting. Previous works with mothers have often assessed each of these factors in isolation despite their frequent co-occurrence. Psychological factors have also been associated with neural processing of facial stimuli, specifically the amplitude (i.e., size) and latency (i.e., timing) of the face-specific N170 event-related potential. In the current study, 106 mothers completed measures assessing maternal psychological factors-anxiety, depression, and substance use. A latent profile analysis was used to identify profiles of psychological factors and assess profile associations with the N170 elicited by infant faces and with parental reflective functioning (PRF) as a measure related to caregiving. Two profiles (termed high and low psychological risk) were identified, with the higher risk profile associated with delayed N170 latency responses to infant faces. An exploratory analysis evidenced an indirect effect between the higher psychological risk profile and lower PRF through delayed N170 latency responses to infant faces. Taken together, maternal psychological risk across multiple indicators may together shape neural processing of infant faces, which may have downstream consequences for caregiving.

Parental substance use and home visiting programs: Implementation considerations for relationship-based treatment.

Home visiting programs can provide critical support to mothers in recovery from substance use disorders (SUDs) and young children prenatally exposed to substances. However, families impacted by maternal SUDs may not benefit from traditional child-focused developmental home visiting services as much as families not impacted by SUDs, suggesting the need to adjust service provision for this population. Given the need to implement tailored services within home visiting programs for families impacted by SUDs, we sought to investigate the implementation barriers and facilitators to inform future integration of a relationship-based parenting intervention developed specifically for parents with SUDs (Mothering from the Inside Out) into home visiting programs. We conducted nine interviews and five focus groups with a racially diverse sample (N = 38) of parents and providers delivering services for families affected by SUDs in the USA. Qualitative content analysis yielded three most prominent themes related to separate implementation domains and their associated barriers and facilitators: (1) engagement, (2) training, and (3) sustainability. We concluded that the home visiting setting may mitigate the logistical barriers to access for families affected by SUDs, whereas relationship-based services may mitigate the emotional barriers that parents with SUDs experience when referred to home visiting programs.

Los programas de visita a casa pueden ofrecer un apoyo clave a madres en recuperación de trastornos por abusos de sustancias (SUD) y los niños pequeños expuestos a sustancia prenatalmente. Sin embargo, las familias que recibieron el impacto de SUD materno pudieran no beneficiarse de los servicios tradicionales de visita a casa en cuanto al desarrollo enfocados en el niño tanto como las familias que no sufren el impacto de SDU, lo cual sugiere la necesidad de ajustar el ofrecimiento de servicios para este grupo de población. Dada la necesidad de implementar servicios amoldados dentro de los programas de visita a casa para familias que sufren el impacto de SUD, nos propusimos investigar las barreras y los aspectos que facilitan la implementación a manera de informar la futura integración de una intervención de crianza con base en la relación, específicamente desarrollada para progenitores con SUD (Cuidados Maternales Desde Dentro) en los programas de visita a casa. Llevamos a cabo nueve entrevistas y cinco grupos de enfoque con un grupo muestra racialmente diverso (N = 38) de progenitores y proveedores que ofrecen los servicios a familias que sufren el impacto de SUD en los Estados Unidos. Los análisis de contenido cualitativo arrojaron tres temas más prominentes relacionados con dominios de implementación separados y las asociadas barreras y aspectos que la facilitan: (1) involucramiento, (2) entrenamiento, y (3) sostenibilidad. Concluimos que el escenario de visita a casa pudiera mitigar las barreras logísticas de acceso para familias afectadas por SUD, mientras que los servicios con base en la relación pudieran mitigar las barreras emocionales que los progenitores con SUD experimentan cuando se les refiere a programas de visita a casa.

Les programmes de visite à domicile peuvent offrir un soutien critique aux mères qui se rétablissent d'un trouble lié à l'usage d'une substance (TUS) et aux jeunes enfants exposés à des substances avant leur naissance. Cependant les familles impactées par des TUS maternels ne bénéficient pas de services de visite à domicile traditionnels autant que des familles non impactées par un TUS, suggérant le besoin d'ajuster des prestations de service pour cette population. Vu le besoin de mettre en place des services adaptés au sein des programmes de visite à domicile pour les familles impactées par des TUS, nous avons décidé d'étudier les barrières et les facteurs de facilitation de mise en place afin d'éclairer l'intégration future d'une intervention de parentage basée sur une relation développée spécifiquement pour des parents avec des TUS (le maternage de l'intérieur suivant l'anglais Mothering from the Inside Out) dans des programmes de visite à domicile. Nous avons procédé à neuf entretiens et cinq groupes d'étude avec un échantille variés du point de vue racial (N = 38) de parents et de prestataires offrant des services pour des familles affectées par des TUS aux Etats-Unis d'Amérique. Une analyse qualitative de contenu a donné trois groupes importants lié à des domaines de mise en place séparés et les barrières et facteurs de facilitation y étant liés: (1) l'engagement, (2) la formation, et (3) la durabilité. Nous concluons que le contexte de visite à domicile peut mitiger les barrières logistiques à l'accès pour les familles affectées par des TUS, alors que les services relationnels peuvent mitiger les barrières émotionnelles dont les parents avec des TUS font l'expérience lorsqu'on leur recommande des programmes de visite à domicile.

Mothering from the Inside Out: Results of a community-based randomized efficacy trial testing a mentalization-based parenting intervention for mothers with addictions.

Mothering from the Inside Out (MIO) is a mentalization-based parenting intervention developed to address challenges common among mothers experiencing substance use disorders (SUDs) and previously deemed effective when delivered by research clinicians. This randomized clinical trial was designed to test the efficacy of MIO when delivered by community-based addiction counselors in Connecticut, USA. Ninety-four mothers [M(SD)age = 31.01(4.01) years; 75.53% White] caring for a child 11-60 months of age were randomly assigned to participate in 12 sessions of either MIO or psychoeducation. Caregiving, psychiatric, and substance use outcomes were assessed repeatedly from baseline through 12-week follow-up. Mothers who participated in MIO showed decreased certainty about their child's mental states, and decreased depression; their children demonstrated increased clarity of cues. Participation in MIO was not associated with the same degree of improvement that was observed in prior trials where MIO was delivered by research clinicians. However, when delivered by community-based clinicians, MIO may be protective against a deterioration in caregiving over time often seen in mothers with addictions. The drop in efficacy of MIO in this trial raises questions about intervention-intervenor fit. Research should examine factors influencing MIO effectiveness to close the science-to-service gap common in the dissemination of empirically validated interventions.

Cuidados Maternales desde Dentro (MIO) es una intervención de crianza con base en la mentalización desarrollada para discutir los retos que son comunes entre las madres que experimentan trastornos de uso de sustancias (SUD) y que previamente eran considerados eficaces cuando los ofrecían los investigadores clínicos. Este ensayo clínico al azar se diseñó para examinar la efectividad de MIO cuando la ofrecen consejeros en asuntos de adicción con base en la comunidad, en Connecticut, Estados Unidos. Noventa y cuatro madres [M(SD) edad = 31.01(4.01) años; 75.53% blancas] con un niño de 11 a 60 meses de edad bajo su cuidado fueron asignadas al azar para participar en 12 sesiones, ya sea de MIO o de psicoeducación. Los resultados del cuidado prestado, los siquiátricos y los de uso de sustancia se evaluaron repetidamente a partir de los datos básicos hasta el seguimiento a las 12 semanas. Las madres que participaron en MIO mostraron una disminución en la certeza acerca de los estados mentales de sus niños, y una disminución en la depresión; sus niños demostraron un aumento en la claridad de las señales. La participación en MIO no se asoció con el mismo grado de mejoramiento que se observó en ensayos previos en los que MIO fue ofrecido por investigadores clínicos. Sin embargo, cuando es ofrecido por clínicos con base comunitaria, MIO pudiera servir de protección contra el deterioro de la prestación de cuidado a lo largo del tiempo, a menudo visto en madres con adicciones. La disminución de la efectividad de MIO en este ensayo genera preguntas acerca de cuán compenetrados está el interventor con la intervención. La investigación debe examinar factores que influyan en la efectividad de MIO para cerrar el vacío entre servicio y ciencia, común en la diseminación de las intervenciones empíricamente validadas.

Le maternage de l'intérieur (abrégé ici MIO pour reprendre l'anglais Mothering from the Inside Out) est une intervention de parentage basée sur la mentalisation, développée afin de répondre aux défis courants chez les mères ayant un trouble lié à l'usage d'une substance (TUS) et préalablement considérée comme efficace lorsque faite par des chercheurs cliniques. Cette étude clinique randomisée a été conçue pour tester l'efficacité du MIO lorsque offert par des intervenants en dépendance communautaires dans l'état du Connecticut aux Etats-Unis. Quatre-vingt-dix-neuf mères [M(SD)âge = 31,01(4,01) ans; 75,53% blanches] prenant soin d'un enfant de 11-60 mois ont été réparties au hasard pour participer soit au MIO soit à une psychoéducation. Les résultats de soins, les résultats psychiatriques et les résultats de toxicomanie ont été évalués de façon répétée de la base jusqu'au suivi à 12 semaines. Les mères ayant participé au MIO ont fait preuve d'une certitude diminuée à propos des états mentaux de leur enfant, et d'une dépression diminuée; leurs enfants ont fait preuve d'une clarté des indices accrue. La participation au MIO n'était pas liée au même degré d'amélioration qui a été observé dans les études préalables quand le MIO a été utilisé par des chercheurs cliniciens. Cependant, lorsqu'administré par des cliniciens communautaires, le MIO pourrait s'avérer protecteur d'une détérioration dans les soins au fil du temps que l'on voit souvent chez les mères toxicomanes. Le déclin d'efficacité du MIO dans cette étude soulève des questions quant à l'ajustement intervention-intervenant. Les recherches devraient se pencher sur les facteurs influençant l'efficacité du MIO pour réduire l'écart de la science au service dans la dissémination d'intervention validées empiriquement.

Training home visitors in mentalization-based practice: A qualitative case study of clinical supervision in mothering from the inside out.

Attachment-based interventions are important for improving parent-child outcomes. These interventions must be scaled and made available to under-resourced communities. An important part of scaling these interventions is delineating and reproducing high-quality training, including clinical training which often requires the completion of a supervised case. However, descriptions and guidelines for clinical training are frequently broad or not available in the literature. A detailed description of clinical training could lead to further research to improve the effectiveness and dissemination of evidence-based interventions. Mothering from the Inside Out (MIO) is an attachment-based parenting intervention effective at reducing substance use and depression, improving caregiving, and enhancing child attachment. It is now being brought from research to community settings. This paper outlines the didactic and clinical training components of MIO. We then present a qualitative case study of one community-based counselor participating in the clinical training of MIO and employ qualitative methods to describe the main themes that arose during the training. We aim to illustrate how the trainer assisted the counselor in implementing the core components of MIO, which included (a) refining the language used in MIO sessions, (b) making space to explore mental states, and (c) addressing trauma. We conclude by presenting the implications of these findings.

Las intervenciones con base en la afectividad son importantes para mejorar los resultados de relación progenitor-niño. Estas intervenciones deben ser adaptadas y estar disponibles para comunidades sin recursos suficientes. Una parte importante de la adaptación de estas intervenciones es delinear y reproducir el entrenamiento de alta calidad, incluyendo entrenamiento clínico que a menudo requiere completar un caso supervisado. Sin embargo, las descripciones y los parámetros de guía para entrenamiento clínico son frecuentemente generales o no están disponibles en el material escrito. Una detallada descripción del entrenamiento clínico pudiera llevar a una posterior investigación para mejorar la eficacia y diseminación de intervenciones con base en la afectividad. Cuidados Maternales de Adentro Hacia Afuera (MIO) es una intervención de crianza con base en la afectividad que es eficaz para reducir el uso de sustancias y la depresión, mejorar la prestación de cuidado y fortalecer la afectividad del niño. Ahora se le lleva de la investigación a los escenarios comunitarios. Este artículo subraya los componentes de didáctica y entrenamiento clínico de MIO. Presentamos entonces un caso de estudio cualitativo de un consejero con base en la comunidad que participó en el entrenamiento clínico de MIO y empleamos métodos cualitativos para describir los temas principales que surgieron durante el entrenamiento. Nos propusimos ilustrar cómo el entrenador ayudó al consejero a implementar los componentes centrales de MIO, los cuales incluyen (a) refinar el lenguaje usado en la terapia, (b) abrir un espacio para explorar estados mentales, y (c) ocuparse del trauma. Concluimos con la presentación de las implicaciones que conllevan estos resultados.

Les interventions basées sur l'attachement sont importantes quand il s'agit d'améliorer les résultats parent-enfant. Ces interventions doivent être mises à l'échelle et doivent être disponibles pour toutes les communautés ayant peu de moyens. Un côté important de la mise à l'échelle de ces interventions consiste à délinéer et à reproduire une formation de haute qualité, y compris une formation clinique qui souvent exige la réalisation d'un cas supervisé. Cependant les descriptions et les lignes directrices de la formation clinique sont fréquemment larges ou ne sont pas disponibles dans des publications. Une description détaillée de formation Clinique pourrait conduire à des recherches approfondies sur la manière d'améliorer l'efficacité et la dissémination d'interventions fondées sur des données probantes. Le maternage de l'intérieur (abrégé ici MIO pour reprendre l'anglais Mothering from the Inside Out) est une intervention de parentage basée sur l'attachement qui est efficace pour ce qui concerne la réduction de toxicomanie et de dépression, l'amélioration des soins ainsi que de l'attachement de l'enfant. On le fait en ce moment passer des recherches aux contextes communautaires. Cet article décrit les composantes de formation didactique et clinique du MIO. Nous présentons ensuite une étude de cas qualitative d'un thérapeute communautaire participant à une formation clinique du MOI et employons des méthodes qualitatives pour décrire les thèmes principaux qui sont apparus durant la formation. Nous nous donnons pour but d'illustrer la manière dont le formateur a aidé le thérapeute à mettre en place les composantes essentielles du MIO, y compris (a) l'affinage du langage utilisé en thérapie, (b) la nécessité de faire de la place afin d'explorer les états mentaux, et (c) la nécessité d'aborder le trauma. Nous concluons en présentant les implications de ces résultats.

Adult attachment is related to maternal neural response to infant cues: an ERP study.

Maternal attachment security is an important predictor of caregiving . However, little is known regarding the neurobiological mechanisms by which attachment influences processing of infant cues, a critical component of caregiving. We examined whether attachment security, measured by the Adult Attachment Interview, might relate to neural responses to infant cues using event-related potentials. Secure (n=35) and insecure (n=24) mothers viewed photographs of infant faces and heard recordings of infant vocalizations while electroencephalography was recorded. We examined initial processing of infant faces (N170) and cries (N100), and attentional allocation to infant faces and cries (P300). Secure mothers were significantly faster than insecure mothers to orient to infant cries (N100), structurally encode their own infant's face (N170), and attend to infant faces (P300). These differences may elucidate mechanisms underlying how attachment may shape neural processing of infant cues and highlight the use ofsocial neuroscientific approaches in examining clinically relevant aspects of attachment.

Reflective functioning in mothers with addictions: Differential relationships involving family history of mental illness and substance use.

Parental reflective functioning (RF) is often cited as an important domain in which mothers with addictions struggle in their roles as parents, though the links between addiction and RF remain unclear. Exposure to attachment trauma associated with parental mental illness and substance use is commonly associated with both addiction and lower RF. We thus examined how family history of parental mental illness and substance use may relate to the RF of mothers with addictions. One hundred ninety-four mothers in outpatient substance use treatment completed the Parent Development Interview and provided information about whether their mothers and fathers experienced mental illness or problems with substance use. Univariate ANOVAs revealed an interaction between family history of maternal mental illness and maternal substance use. Among mothers with a history of maternal substance use, those with a history of maternal mental illness had higher RF than those who had no history of maternal mental illness. Among mothers who did not report a family history of maternal mental illness, mothers who had a family history of maternal substance use exhibited significantly lower RF than mothers with no family history of maternal substance use. Exposure to paternal mental illness or substance use was not associated with mothers' RF. These findings highlight the importance of disentangling the contributions of attachment trauma to mothers' RF and utilizing interventions that support mothers' capacity to reflect about how their early experiences of being cared for by a mother with a mental illness or addiction may impact their current caregiving behaviors.

An intergenerational lifespan perspective on the neuroscience of prenatal substance exposure.

Prenatal substance exposure has the potential to impact a variety of domains, with neurobiological effects that last throughout the lifespan. Different substances may impact the brain in both specific and diffuse ways; however, the aberrant neural outcomes following exposure tend to coalesce in three areas: (1) sensorimotor development; (2) arousal, motivation, and reward; and (3) executive functioning, impulse control, and emotion regulation. This manuscript represents a summary and update of a previous review (Morie et al., 2019). We organize this piece by domain and summarize data from published neuroimaging studies that examine the neural correlates of prenatal exposure across developmental stages. While the published neuroimaging literature in the area of prenatal exposure has a range of sampling concerns that may limit generalizability as well as longitudinal prediction, the findings to date do point to domains of interest warranting further study. With this caveat, we synthesize the extant findings to describe ways in which prenatal substance exposure is associated with developmental psychopathology and implicated in potentially aberrant behavioral patterns beginning in infancy and persisting through childhood, adolescence, adulthood, and even parenthood. We also examine how substance abuse may impact parenting behaviors that in turn influences infant and child behavior in ways that may be additive or obscure the direct teratological effects of prenatal exposure. Given this observation, we offer an additional intergenerational lens through which prenatal substance exposure should be studied.

The effects of prenatal stress on neural responses to infant cries in expectant mothers and fathers.

The perinatal period is characterized by distinct neurobiological and psychological changes initiated prenatally, which may both facilitate postpartum caregiving and increase vulnerability to stress. Parents need to adapt to the high demands of caregiving, which include responding to salient infant cues, such as infant cries. Therefore, assessing the impact of prenatal stress exposure on parents' neural processing of infant cries may elucidate mechanisms conferring early risk for detrimental perinatal outcomes. Using event-related potentials, we examined whether prenatal perceived stress affected neural markers of perceptual (N1, P2) and attentional (LPP) processes elicited by high- and low-distress infant cries in expectant mothers (n = 38) and fathers (n = 30). Results evidenced that prenatal perceived stress impacted parents' sustained attentional processing (LPP) of infant cries, but not early perceptual responses (N1, P2). Specifically, higher levels of prenatal perceived stress were associated with a greater LPP response to low-distress, but not high-distress, infant cries. There were no parental sex differences in prenatal perceived stress or neural responses to infant cries. Increased attentional processing of low-distress cries in highly stressed parents may reflect uncertainty regarding infant distress level, thereby requiring more attentional resources. Overall, our results suggest that prenatal stress impacts processing of infant cues, even before birth.

Relationship-Based Home Visiting Services for Families Affected by Substance Use Disorders: A Qualitative Study.

Home visiting programs face many challenges when providing evidence-based services to families affected by substance use disorders (SUDs). We conducted interviews and focus groups with community stakeholders and parents to elucidate important considerations when intentionally attempting to meet the needs of families affected by SUDs through home visiting programs. We identified one primary theme "Who is the client?" that describes how to ensure caregivers perceive themselves as an important focus of the program. Collectively, participants revealed that understanding caregivers' emotional experiences was critical for effectively transforming their subjective experiences of the program. These emotional experiences were related to the quality of their relationships with their children, other family members, and service providers. Three sub-themes illustrate specific examples: 1) responding to the unique emotional needs of mothers in recovery, 2) considering emotional states to inform inclusion in programs, and 3) addressing complex family dynamics related to SUDs in the home. Implications of these findings are discussed.

Mothering from the Inside Out: Addressing the Intersection of Addiction, Adversity, and Attachment with Evidence-Based Parenting Intervention.

Purpose of Review: Mothers with substance use disorders are often referred for parenting support, though commonly available programs may miss the mark for families impacted by addiction. This may be related to a lack of attention to children's emotional needs, mothers' histories of adversity, and the neurobiological differences seen in mothers with addictions. We review the implications of addiction, adversity, and attachment for parenting interventions. We then describe Mothering from the Inside Out (MIO), an evidence-based parenting intervention designed specifically for mothers with addictions. Recent Findings: Evidence from clinical trials suggests that MIO improves outcomes for two generations: both mothers with addictions and their children. Recent trials demonstrate that MIO may be delivered effectively by community-based clinicians and may be beneficial for parents with other chronic stressors. Summary: Addressing addiction, adversity, and attachment simultaneously may have a positive synergistic effect. Future research should study the implementation of MIO in real-world settings and examine the impact of MIO on maternal neurobiology.

Substance use and mothers' neural responses to infant cues.

Substance use may influence mothers' responsiveness to their infants and negatively impact the parent-infant relationship. Maternal substance use may co-opt neural circuitry involved in caregiving, thus reducing the salience of infant cues and diminishing the sense of reward experienced by caring for infants. Gaps in understanding exist with regard to the mechanisms by which substance use operates to influence mothers' processing of infant cues and how this translates to caregiving. Therefore, we examined how substance use might relate to maternal neural responses to infant cues using event-related potentials (ERPs). Substance-using (n = 29) and nonsubstance-using (n = 29) mothers viewed photographs of infant faces and heard recordings of infant vocalizations while electroencephalography was recorded simultaneously. Three specific ERP components were used to examine initial processing of infant faces (N170) and cries (N100), and attentional allocation to infant faces and cries (P300). Substance-using mothers did not discriminate facial affect at early encoding stages (N170), were generally slower to orient to infant cries (N100), showed heightened responses to neutral faces (P300), and failed to adaptively differentiate between high-distress versus low-distress cries (P300). These differences may be important to caregiving behaviors associated with the formation of mother-child attachment. Implications are discussed, as are limitations and future directions.

The state of evidence-based parenting interventions for parents who are substance-involved.

Approximately 70 million children and adolescents live with at least one parent who abuses or is dependent on alcohol or an illicit substance. Given the negative parenting practices that substance-involved mothers and fathers tend to exhibit as well as the poor outcomes that their children, particularly their young children, experience, evidence-based parenting interventions are an important complement to substance abuse treatments. At this time, there are few studies that compare the efficacy of parenting interventions for these parents, however. Nonetheless, research has begun to examine skill-based and attachment-based parenting interventions for substance-involved families with young children. These parenting interventions should be considered within the context of the neurobiology of substance abuse, which emphasizes the role of dopamine in the reward systems that promote substance use. In the context of these neurobiological connections, parenting interventions that engender repeated intense emotional experiences may stimulate this same reward system and, therefore, may be more efficacious. Attachment-based interventions are particularly promising when such connections are considered. More attention needs to be paid to bringing impactful parenting interventions to substance-involved parents with young children.

Bipolar disorder in children.

Although bipolar disorder historically was thought to only occur rarely in children and adolescents, there has been a significant increase in children and adolescents who are receiving this diagnosis more recently (Carlson, 2005). Nonetheless, the applicability of the current bipolar disorder diagnostic criteria for children, particularly preschool children, remains unclear, even though much work has been focused on this area. As a result, more work needs to be done to further the understanding of bipolar symptoms in children. It is hoped that this paper can assist psychologists and other health service providers in gleaning a snapshot of the literature in this area so that they can gain an understanding of the diagnostic criteria and other behaviors that may be relevant and be informed about potential approaches for assessment and treatment with children who meet bipolar disorder criteria. First, the history of bipolar symptoms and current diagnostic criteria will be discussed. Next, assessment strategies that may prove helpful for identifying bipolar disorder will be discussed. Then, treatments that may have relevance to children and their families will be discussed. Finally, conclusions regarding work with children who may have a bipolar disorder diagnosis will be offered.

The role of attachment in the relationship between child maltreatment and later emotional and behavioral functioning.

The experience of childhood maltreatment is an important predictor of unfavorable emotional and behavioral outcomes. Because little research examined explanatory variables in the relationship between childhood maltreatment experiences and later outcomes, this study examined the role that attachment serves in this relationship. Four hundred twenty-four participants completed questionnaires assessing the variables of interest for this study. Results indicated that both childhood maltreatment experiences (particularly emotional abuse) and attachment (particularly to mothers and peers) are significant predictors of later emotional and behavioral outcomes. Further, attachment contributed unique and significant variance to the relationship between childhood maltreatment experiences and later outcomes. Such findings suggested that secure attachment may serve as a protective factor against maladaptive emotional and behavioral outcomes as children reach emerging adulthood, even in the context of childhood maltreatment experiences. The importance of studying the relationships among these variables is discussed.

Near-infrared spectroscopy for the determination of testosterone in thin-film composites.

More rapid, reproducible, and cost-effective methods to control product quality in the pharmaceutical industry continue to be a major emphasis, particularly with the FDA through its recent process analytical technologies (PAT) initiative. Many different methods have been used to determine the stability and content uniformity of a drug in various dosage forms; however, most of these methods include the destruction of the sample. Therefore, the development of nondestructive methods that allow the analysis of each individual dosage form has become the basis of much research. A new assay for the nondestructive determination of testosterone content in mucoadhesive bi-layer thin-film composites (TFCs) using near-infrared spectroscopy (NIR) was developed. Five sets of the circular films (n=5) with theoretical testosterone content of 0, 1, 2, 3, and 4 mg per 3/8th in. diameter disks were scanned in the near-infrared region of 1100-2500 nm to determine testosterone content. The NIR results were directly compared with those obtained using a previously developed ultraviolet assay for testosterone at 240 nm. Principal component regression (PCR) was performed to calibrate the NIR assay. This correlation produced r2=0.99 with a standard error of estimate (SEE)=0.18 mg, and a standard error of performance (SEP)=0.18 on cross validation with an equal number of samples (F test passed at P=0.05). Though the UV assay showed a slightly better r2 value, the NIR assay was much quicker, easier, and nondestructive. Therefore, the NIR assay may have significant potential for use in the quality control of pharmaceutical films containing drugs.

Hyperspectral techniques in analysis of oral dosage forms.

Pharmaceutical oral dosage forms are used in this paper to test the sensitivity and spatial resolution of hyperspectral imaging instruments. The first experiment tested the hypothesis that a near-infrared (IR) tunable diode-based remote sensing system is capable of monitoring degradation of hard gelatin capsules at a relatively long distance (0.5 km). Spectra from the capsules were used to differentiate among capsules exposed to an atmosphere containing 150 ppb formaldehyde for 0, 2, 4, and 8 h. Robust median-based principal component regression with Bayesian inference was employed for outlier detection. The second experiment tested the hypothesis that near-IR imaging spectrometry of tablets permits the identification and composition of multiple individual tablets to be determined simultaneously. A near-IR camera was used to collect thousands of spectra simultaneously from a field of blister-packaged tablets. The number of tablets that a typical near-IR camera can currently analyze simultaneously was estimated to be approximately 1300. The bootstrap error-adjusted single-sample technique chemometric-imaging algorithm was used to draw probability-density contour plots that revealed tablet composition. The single-capsule analysis provides an indication of how far apart the sample and instrumentation can be and still maintain adequate signal-to-noise ratio (S/N), while the multiple-tablet imaging experiment gives an indication of how many samples can be analyzed simultaneously while maintaining an adequate S/N and pixel coverage on each sample.