scholarly journals Multipurpose Prevention Technologies: Oral, Parenteral, and Vaginal Dosage Forms for Prevention of HIV/STIs and Unplanned Pregnancy

Polymers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 2450
Author(s):  
Isabella C. Young ◽  
Soumya Rahima Benhabbour
Keyword(s):  
Patient Adherence ◽  
Unplanned Pregnancy ◽  
Controlled Drug Release ◽  
Prolonged Release ◽  
Formulation Development ◽  
Preclinical Development ◽  
Comprehensive Overview ◽  
Unplanned Pregnancies ◽  
Dosing Regimens ◽  
Multiple Drugs

There is a high global prevalence of HIV, sexually transmitted infections (STIs), and unplanned pregnancies. Current preventative daily oral dosing regimens can be ineffective due to low patient adherence. Sustained release delivery systems in conjunction with multipurpose prevention technologies (MPTs) can reduce high rates of HIV/STIs and unplanned pregnancies in an all-in-one efficacious, acceptable, and easily accessible technology to allow for prolonged release of antivirals and contraceptives. The concept and development of MPTs have greatly progressed over the past decade and demonstrate efficacious technologies that are user-accepted with potentially high adherence. This review gives a comprehensive overview of the latest oral, parenteral, and vaginally delivered MPTs in development as well as drug delivery formulations with the potential to advance as an MPT, and implementation studies regarding MPT user acceptability and adherence. Furthermore, there is a focus on MPT intravaginal rings emphasizing injection molding and hot-melt extrusion manufacturing limitations and emerging fabrication advancements. Lastly, formulation development considerations and limitations are discussed, such as nonhormonal contraceptive considerations, challenges with achieving a stable coformulation of multiple drugs, achieving sustained and controlled drug release, limiting drug–drug interactions, and advancing past preclinical development stages. Despite the challenges in the MPT landscape, these technologies demonstrate the potential to bridge gaps in preventative sexual and reproductive health care.

scholarly journals Proportion of unplanned pregnancies, their determinants and health outcomes of women delivering at a teaching hospital in Sri Lanka

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Iddamalgoda Dissanayakage Jayani Ch Ranatunga ◽  
Kapila Jayaratne
Keyword(s):  
Health Outcomes ◽  
Teaching Hospital ◽  
Unplanned Pregnancy ◽  
Public Health Issue ◽  
Maternal And Newborn Health ◽  
Discharge Data ◽  
Low Mood ◽  
Inadequate Knowledge ◽  
Unplanned Pregnancies ◽  
Emergency Contraceptives

Abstract Background Unplanned pregnancy is a significant public health issue in both low- and high-income countries. The burden of unplanned pregnancy is reflected in women opting for pregnancy terminations and it can be detrimental to the women and her family as well as the health system and society. Solid data on the proportion of unplanned pregnancies are using more specific tools such as the London Measure of Unplanned Pregnancy (LMUP) needed to address the issue in Sri Lankan contexts. The objective was to describe the proportion of unplanned pregnancies, their determinants and the health outcomes of women delivering at Colombo North Teaching Hospital-Ragama (CNTH). Methods A cross-sectional study was carried out among 494 consecutive pregnant women selected by non-probability consecutive sampling who were admitted for the confinement at CNTH. A pre-tested structured interviewer-administered questionnaire was used to collect data on antenatal women and intentionality measured by self-administered six-item LMUP. Maternal and newborn health outcomes were ascertained in each post-partum women before discharge. Data were analyzed with the Mann-Whitney U tests, Kruskal-Wallis tests and spearman rank correlation. We also evaluated the psychometric properties of the Sinhalese version of LMUP. Results The response rate was 97.8 and 17.2% of pregnancies ending at birth were unplanned, 12.7% were ambivalent and 70.1% were planned. Associated factor profile of women with unplanned pregnancies includes; not married women (p = 0.001), educated up to the passing of GCE ordinary level by women (p <  0.001) and spouse (p <  0.001), primiparity (p = 0.002) and inadequate knowledge on emergency contraceptives (p = 0.037). Less planned pregnancies were also significantly associated with anemia (p = 0.004), low mood for last 2 weeks (p <  0.001), having a partner with problematic alcohol consumption (p <  0.001), presence of Gender-Based Violence (GBV) (p < 0.001), poor relationship satisfaction with partner (p < 0.001) and family (p < 0.001). Inadequate pre-pregnancy preparation and antenatal care were associated with an unplanned pregnancy. No differences were found in neonatal outcomes. Sinhalese version of the LMUP scale was found to be accepted, valid and reliable with the Cronbach’s alpha of 0.936. Conclusions A sizeable proportion of pregnancies were unplanned. Teenage pregnancies, non-marital relationships and inadequate knowledge on emergency contraceptives, maternal anemia, low mood, and GBV were modifiable associated factors which could be prevented by evidence-based locally applicable approaches.

scholarly journals Therapeutic drug monitoring in special populations

1998 ◽  
Vol 44 (2) ◽  
pp. 415-419 ◽  
Author(s):  
Philip D Walson
Keyword(s):  
Therapeutic Drug Monitoring ◽  
Drug Monitoring ◽  
Diagnostic Testing ◽  
Drug Effects ◽  
Special Populations ◽  
Therapeutic Drug ◽  
Drug Reactions ◽  
Drug Concentrations ◽  
Dosing Regimens ◽  
Multiple Drugs

Abstract Therapeutic drug monitoring (TDM) is commonly used to maintain “therapeutic” drug concentrations. Even in compliant patients, with “average” drug kinetics, TDM is useful to identify the causes of unwanted or unexpected responses, prevent unnecessary diagnostic testing, improve clinical outcomes, and even save lives. TDM has greatest promise in certain special populations who are: (a) prone to under- or overrespond to usual dosing regimens, (b) least able to tolerate, recognize, or communicate drug effects, or who are (c) intentionally or accidentally misdosed. TDM is especially useful in patients at the extremes of age, in adolescents, and in patients who are either taking multiple drugs or expressing unusual pharmacokinetics as a result of physiological, environmental, or genetic causes. Less-well-appreciated uses of TDM include prevention of dangerousunderdosing of patients, investigation of adverse drug reactions, and identification of serious medication errors, even for a number of drugs that are not traditionally monitored. TDM can be useful for some drugs in any patient and for most drugs in some special populations.

scholarly journals Modern approaches to drug treatment for vestibular vertigo

2021 ◽  
Vol 13 (1) ◽  
pp. 101-106
Author(s):  
M. V. Zamergrad ◽  
S. V. Morozova
Keyword(s):  
Patient Adherence ◽  
Beta Blockers ◽  
Antiviral Agents ◽  
Symptomatic Treatment ◽  
New Drugs ◽  
Dopamine Antagonists ◽  
Prolonged Release ◽  
Release Formulation ◽  
Hunt Syndrome ◽  
Vestibular Vertigo

In recent years, some progress has been achieved in elaborating the algorithms and standards for the treatment of many conditions accompanied by vertigo. The current possibilities of treating vestibular vertigo consist of a gradually expanding arsenal of symptomatic and pathogenetic drugs. Among the drugs used for the symptomatic treatment of vestibular vertigo, there are vestibular suppressants (antihistamines, benzodiazepines, and calcium antagonists) and antiemetics (dopamine antagonists and serotonin 5-HT3 receptor antagonists). The paper discusses the possibilities of using betahistine and vitamin D as pathogenetic agents for recurrent benign paroxysmal positional vertigo; diuretics, betahistine (including the new prolonged release formulation Betaserc® Long), glucocorticoids, and gentamicin for Meniere's disease; triptans, beta-blockers, tricyclic antidepressants, and anticonvulsants for vestibular migraine; glucocorticoids, antiviral agents, and drugs that accelerate vestibular compensation for acute unilateral peripheral vestibulopathy (vestibular neuritis and Ramsey Hunt syndrome).The emergence of new drugs, as well as the design of new dosage forms that enhance patient adherence to the prescribed treatment, can improve quality of life in patients suffering from diseases that have recently led to long-term disability or even incapacitation.

scholarly journals Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a c4c expert group White paper.

2021 ◽  
Author(s):  
Jennifer Walsh ◽  
Daniel Schaufelberger ◽  
Sonia Lurian ◽  
Sandra Klein ◽  
Hannah Batchelor ◽  
...  
Keyword(s):  
Decision Making ◽  
Age Groups ◽  
White Paper ◽  
Formulation Development ◽  
Effective Age ◽  
New Chemical Entities ◽  
Dosing Regimens ◽  
Post Marketing ◽  
Age Appropriate ◽  
Paediatric Formulation

Improved global access to novel age-appropriate formulations for paediatric subsets, either of new chemical entities or existing drugs, is a priority to ensure that medicines meet the needs of these patients. However, despite regulatory incentives, the introduction to the market of paediatric formulations still lags behind adult products. This is mainly caused by additional complexities associated with the development of acceptable age-appropriate paediatric medicines. This position paper proposes the use of a paediatric Quality Target Product Profile (pQTPP) as an efficient tool to facilitate early planning and decision making during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs. Essential key attributes of a paediatric formulation are suggested and described. Moreover, greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products. Acceptability testing should be a secondary endpoint in paediatric clinical trials to ensure post-marketing adherence is not compromised by a lack of acceptability. Not knowing the indications and the related age groups and potential dosing regimens early enough is still a major hurdle for efficient paediatric formulation development; however the proposed pQTPP could be a valuable collaborative tool for planning and decision making to expedite paediatric product development.

scholarly journals The Agony of Choice—Where to Place the Wave of BCMA-Targeted Therapies in the Multiple Myeloma Treatment Puzzle in 2022 and Beyond

Cancers ◽  
2021 ◽  
Vol 13 (18) ◽  
pp. 4701
Author(s):  
Irene Strassl ◽  
Martin Schreder ◽  
Normann Steiner ◽  
Jakob Rudzki ◽  
Hermine Agis ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Decision Making ◽  
Nk Cell ◽  
Clinical Stage ◽  
Proteasome Inhibitors ◽  
Treatment Strategies ◽  
Clinical Trial Data ◽  
Clinical Decision ◽  
Preclinical Development ◽  
Comprehensive Overview

Since the introduction of first-generation proteasome inhibitors and immunomodulatory agents, the multiple myeloma (MM) treatment landscape has undergone a remarkable development. Most recently, immunotherapeutic strategies targeting the B cell maturation antigen (BCMA) entered the clinical stage providing access to highly anticipated novel treatment strategies. At present, numerous different approaches investigate BCMA as an effective multi-modal target. Currently, BCMA-directed antibody–drug conjugates, bispecific and trispecific antibodies, autologous and allogeneic CAR-T cell as well as CAR-NK cell constructs are either approved or in different stages of clinical and preclinical development for the treatment of MM. This armamentarium of treatment choices raises several challenges for clinical decision making, particularly in the absence of head-to-head comparisons. In this review, we provide a comprehensive overview of BCMA-targeting therapeutics, deliver latest updates on clinical trial data, and focus on potential patient selection criteria for different BCMA-targeting immunotherapeutic strategies.

scholarly journals Proportion of unplanned pregnancies, their determinants and health outcomes of women delivering at a teaching hospital in Sri Lanka

2020 ◽  
Author(s):  
Jayani Chalindra Ranatunga ◽  
Kapila Jayaratne
Keyword(s):  
Health Outcomes ◽  
Teaching Hospital ◽  
Unplanned Pregnancy ◽  
Public Health Issue ◽  
Maternal And Newborn Health ◽  
Discharge Data ◽  
Low Mood ◽  
Inadequate Knowledge ◽  
Unplanned Pregnancies ◽  
Emergency Contraceptives

Abstract Background Unplanned pregnancy is a significant public health issue in both low- and high-income countries. The burden of unplanned pregnancy is reflected in women opting for pregnancy terminations and it can be detrimental to the women and her family as well as the health system and society. Solid data on the proportion of unplanned pregnancies are using more specific tools such as the London Measure of Unplanned Pregnancy (LMUP) needed to address the issue in Sri Lankan contexts. The objective was to describe the proportion of unplanned pregnancies, their determinants and the health outcomes of women delivering at Colombo North Teaching Hospital-Ragama (CNTH).Methods A cross-sectional study was carried out among 494 consecutive pregnant women selected by non-probability consecutive sampling who were admitted for the confinement at CNTH. A pre-tested structured interviewer-administered questionnaire was used to collect data on antenatal women and intentionality measured by self-administered six-item LMUP. Maternal and newborn health outcomes were ascertained in each post-partum women before discharge. Data were analyzed with the Mann-Whitney U tests, Kruskal-Wallis tests and spearman rank correlation. We also evaluated the psychometric properties of the Sinhalese version of LMUP. Results The response rate was 97.8% and 17.2% of pregnancies ending at birth were unplanned, 12.7% were ambivalent and 70.1% were planned. Associated factor profile of women with unplanned pregnancies includes; not married women (p=0.001), educated up to the passing of GCE ordinary level by women (p<0.001) and spouse (p<0.001), primiparity (p=0.002) and inadequate knowledge on emergency contraceptives (p=0.037). Less planned pregnancies were also significantly associated with anemia (p=0.004), low mood for last two weeks (p<0.001), having a partner with problematic alcohol consumption (p<0.001), presence of Gender-Based Violence (GBV) (p<0.001), poor relationship satisfaction with partner (p<0.001) and family (p<0.001). Inadequate pre-pregnancy preparation and antenatal care were associated with an unplanned pregnancy. No differences were found in neonatal outcomes. Sinhalese version of the LMUP scale was found to be accepted, valid and reliable with the Cronbach's alpha of 0.936. Conclusions A sizeable proportion of pregnancies were unplanned. Teenage pregnancies, non-marital relationships and inadequate knowledge on emergency contraceptives, maternal anemia, low mood, and GBV were modifiable associated factors which could be prevented by evidence-based locally applicable approaches.

Lipoidal Nano Architect for Parental Drug Delivery: Formulation Development and Regulatory Concerns

2020 ◽  
Vol 04 ◽  
Author(s):  
Vikas Jhawat ◽  
Anil Kumar Sharma ◽  
Vandana Garg ◽  
Rohit Dutt ◽  
Monika Gulia
Keyword(s):  
Scale Up ◽  
Controlled Drug Release ◽  
Drug Carriers ◽  
Formulation Development ◽  
Polymeric Systems ◽  
Parenteral Route ◽  
Regulatory Guidelines ◽  
Immunological Reactions ◽  
As Toxicity ◽  
Regulatory Challenges

: The nanoparticles as drug carriers have demonstrated enhanced targeting, sustained/controlled drug release as evident from numerous investigations which have shown promising outcomes facilitating the wellbeing of humans in a desired manner. The lipid based nanoparticulates are biodegradable and considered biocompatible by virtue of being composed of lipid moieties mimicking physiological lipids of biological systems which is their prime advantage over the other polymeric systems. A variety of such lipid carriers have been reported to be delivered from parenteral route. However, there are certain pitfalls which are associated with lipid nanoparticulates such as toxicity, poor scale up potential, immunological reactions and absence of straight forward regulatory guidelines which address the issues of lipoidal nanocarriers such as their classification, approval and compliance of governmental policies. Therefore attention must be given to address the technological and regulatory challenges associated with lipoidal nano-formulations for parenteral administration to smoothen the approval process throughout the world and bringing the same to the terminal users on time.

Intendedness of pregnancies and preconception contraceptive use in women of Swedish and non-European origins seeking emergency care in early pregnancy

2021 ◽  
pp. bmjsrh-2020-200970
Author(s):  
Marcus Bergman ◽  
Anna-Maria Gray ◽  
Nina Sollier ◽  
Markus Sjöstrand ◽  
Helena Kopp Kallner
Keyword(s):  
Unintended Pregnancy ◽  
Early Pregnancy ◽  
Emergency Care ◽  
Contraceptive Use ◽  
Unplanned Pregnancy ◽  
Tertiary Hospital ◽  
Unintended Pregnancies ◽  
Sociodemographic Data ◽  
Unplanned Pregnancies ◽  
Unselected Population

IntroductionUnintended pregnancies in Europe have been estimated to constitute 43% of all pregnancies, with the proportion in Sweden being unknown. In striving for equitable healthcare, increased knowledge about unintended pregnancies among women born outside Europe is needed. We aimed to estimate the proportion of unintended pregnancies in women born in Sweden compared with women born outside Europe in an unselected population seeking gynaecological emergency care in early pregnancy. Our secondary aim was to compare contraceptive use at the time of conception in unplanned pregnancies between women born in Sweden and women born outside Europe.MethodsPregnant women seeking gynaecological emergency care in early pregnancy at a tertiary hospital were asked to fill out a questionnaire in their native language. The questionnaire contained questions from the London Measure of Unplanned Pregnancy (LMUP) and questions regarding sociodemographic data, gynaecological health and previous contraception.ResultsOf 180 pregnancies, 66 were unintended (36.7%) according to the LMUP. Among patients born in Sweden, 49/129 (38.0%) of the pregnancies were unintended compared with 17/51 (33.3%) among patients born outside Europe (p=0.56). 86% of participants with unintended pregnancy did not use any form of contraception during the month of conception, with no difference between women born in Sweden and those born outside Europe.ConclusionsAmong women seeking gynaecological emergency care in early pregnancy, unintended pregnancies are common. Women with unintended pregnancies had low use of preconception contraceptives, which highlights a need for further interventions aimed at avoiding unintended pregnancies.

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