Novel Drug Delivery Systems for Women's Health

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Delivery and Controlled Release".

Deadline for manuscript submissions: closed (15 December 2023) | Viewed by 8746

Special Issue Editors


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Guest Editor
Center for Biomedical Research, Population Council, 1230 York Avenue, New York, NY 10065, USA
Interests: vaginal drug delivery; HIV/STI prevention and contraception; multipurpose prevention technology (MPT) products, vaginal health; user acceptability and adherence; pharmaceutical development and manufacturing in Africa

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Guest Editor
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria
Interests: HIV /AIDS prevention; wound healing; electrospun fibers; hydrogels; organogels and biogels for transdermal drug delivery and vaginal drug delivery; artificial neural networks

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Guest Editor
Center for Biomedical Research, Population Council, 1230 York Avenue, New York, NY 10065, USA
Interests: HIV/AIDS prevention; nanomedicine; mucosal interfacing; vaginal drug delivery; fast dissolving insert

Special Issue Information

Dear Colleagues,

Women’s health issues represent a major concern in both research and medical practice. Often dismissed, the specific health needs of women have been underappreciated and targeted scientific research is lacking.

We are focusing this special issue on innovative drug formulation and drug delivery systems that can help address the unmet health needs of women worldwide. Importantly, user acceptability is a key attribute that must be incorporated early in the design and testing of any new delivery system.

Non-gender-specific implantable, injectable, oral, and topical dosage forms can potentially address the unmet needs for women’s health. Meanwhile, cis female-specific products such as vaginally administered fast dissolving inserts, gels, and intravaginal rings can have favorable pharmacological profiles and high user acceptability.

We are interested in drug delivery systems that address a wide range of women’s health needs including vaginal health; contraception and pregnancy; sexually transmitted infections; and genitourinary symptoms of menopause. We encourage submissions that address other women’s health issues as well.

This Special Issue will highlight and capture the latest developments in drug delivery systems for women's health. We invite original and review articles in this field to accelerate scientific knowledge and pharmaceutical advancement.

Dr. Thomas M. Zydowsky
Dr. Margaret Ilomuanya
Dr. Pavimol Angsantikul
Guest Editors

Manuscript Submission Information

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Keywords

  • vaginal drug delivery
  • nanomedicine
  • artificial neural network-aided drug design
  • sexually transmitted infections including HIV
  • contraceptives
  • multipurpose prevention technology (MPT) products
  • management of vaginal and vulvar health
  • pregnancy and preterm birth
  • gynecological disorders and oncology
  • genitourinary symptoms of menopause

Published Papers (4 papers)

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Research

8 pages, 1176 KiB  
Communication
Model-Based Analysis of In Vivo Release Data of Levonorgestrel Implants: Projecting Long-Term Systemic Exposure
by Soyoung Kim, Brian Cicali, Michelle Pressly, Lais Da Silva, Thomas Wendl, Valvanera Vozmediano, Stephan Schmidt and Rodrigo Cristofoletti
Pharmaceutics 2023, 15(5), 1393; https://doi.org/10.3390/pharmaceutics15051393 - 02 May 2023
Cited by 1 | Viewed by 1297
Abstract
Levonorgestrel (LNG) is a progestin used in many contraceptive formulations, including subcutaneous implants. There is an unmet need for developing long-acting formulations for LNG. To develop long-acting formulations, release functions need to be investigated for LNG implant. Therefore, a release model was developed [...] Read more.
Levonorgestrel (LNG) is a progestin used in many contraceptive formulations, including subcutaneous implants. There is an unmet need for developing long-acting formulations for LNG. To develop long-acting formulations, release functions need to be investigated for LNG implant. Therefore, a release model was developed and integrated into an LNG physiologically-based pharmacokinetic (PBPK) model. Utilizing a previously developed LNG PBPK model, subcutaneous administration of 150 mg LNG was implemented into the modeling framework. To mimic LNG release, ten functions incorporating formulation-specific mechanisms were explored. Release kinetic parameters and bioavailability were optimized using Jadelle® clinical trial data (n = 321) and verified using two additional clinical trials (n = 216). The First-order release and Biexponential release models showed the best fit with observed data, the adjusted R-squared (R2) value is 0.9170. The maximum released amount is approximately 50% of the loaded dose and the release rate is 0.0009 per day. The Biexponential model also showed good agreement with the data (adjusted R2 = 0.9113). Both models could recapitulate observed plasma concentrations after integration into the PBPK simulations. First-order and Biexponential release functionality may be useful in modeling subcutaneous LNG implants. The developed model captures central tendency of the observed data as well as variability of release kinetics. Future work focuses on incorporating various clinical scenarios into model simulations, including drug-drug interactions and a range of BMIs. Full article
(This article belongs to the Special Issue Novel Drug Delivery Systems for Women's Health)
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20 pages, 3078 KiB  
Article
Development of Mucoadhesive Electrospun Scaffolds for Intravaginal Delivery of Lactobacilli spp., a Tenside, and Metronidazole for the Management of Bacterial Vaginosis
by Margaret O. Ilomuanya, Peace O. Bassey, Deborah A. Ogundemuren, Uloma N. Ubani-Ukoma, Alkiviadis Tsamis, Yuwei Fan, Konstantinos Michalakis, Pavimol Angsantikul, Abdulrahman Usman and Andrew N. Amenaghawon
Pharmaceutics 2023, 15(4), 1263; https://doi.org/10.3390/pharmaceutics15041263 - 18 Apr 2023
Cited by 4 | Viewed by 1449
Abstract
Bacterial vaginosis (BV) is an infection of the vagina associated with thriving anaerobes, such as Gardnerella vaginitis and other associated pathogens. These pathogens form a biofilm responsible for the recurrence of infection after antibiotic therapy. The aim of this study was to develop [...] Read more.
Bacterial vaginosis (BV) is an infection of the vagina associated with thriving anaerobes, such as Gardnerella vaginitis and other associated pathogens. These pathogens form a biofilm responsible for the recurrence of infection after antibiotic therapy. The aim of this study was to develop a novel mucoadhesive polyvinyl alcohol and polycaprolactone electrospun nanofibrous scaffolds for vaginal delivery, incorporating metronidazole, a tenside, and Lactobacilli. This approach to drug delivery sought to combine an antibiotic for bacterial clearance, a tenside biofilm disruptor, and a lactic acid producer to restore healthy vaginal flora and prevent the recurrence of bacterial vaginosis. F7 and F8 had the least ductility at 29.25% and 28.39%, respectively, and this could be attributed to the clustering of particles that prevented the mobility of the crazes. F2 had the highest at 93.83% due to the addition of a surfactant that increased the affinity of the components. The scaffolds exhibited mucoadhesion between 31.54 ± 0.83% and 57.86 ± 0.95%, where an increased sodium cocoamphoacetate concentration led to increased mucoadhesion. F6 showed the highest mucoadhesion at 57.86 ± 0.95%, as compared to 42.67 ± 1.22% and 50.89 ± 1.01% for the F8 and F7 scaffolds, respectively. The release of metronidazole via a non-Fickian diffusion-release mechanism indicated both swelling and diffusion. The anomalous transport within the drug-release profile pointed to a drug-discharge mechanism that combined both diffusion and erosion. The viability studies showed a growth of Lactobacilli fermentum in both the polymer blend and the nanofiber formulation that was retained post-storage at 25 °C for 30 days. The developed electrospun scaffolds for the intravaginal delivery of Lactobacilli spp., along with a tenside and metronidazole for the management of bacterial vaginosis, provide a novel tool for the treatment and management of recurrent vaginal infection. Full article
(This article belongs to the Special Issue Novel Drug Delivery Systems for Women's Health)
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25 pages, 8578 KiB  
Article
Quality by Design Assisted Optimization and Risk Assessment of Black Cohosh Loaded Ethosomal Gel for Menopause: Investigating Different Formulation and Process Variables
by Sradhanjali Mohapatra, Mohd. Aamir Mirza, Sayeed Ahmad, Uzma Farooq, Mohammad Javed Ansari, Kanchan Kohli and Zeenat Iqbal
Pharmaceutics 2023, 15(2), 465; https://doi.org/10.3390/pharmaceutics15020465 - 31 Jan 2023
Cited by 11 | Viewed by 2189
Abstract
Black cohosh (Cimicifuga racemosa) (CR) is a popular herb and is medically lauded for ameliorating myriad symptoms associated with menopause. However, its pharmaceutical limitations and non-availability of a patient-compliant drug delivery approach have precluded its prevalent use. Henceforth, the current research [...] Read more.
Black cohosh (Cimicifuga racemosa) (CR) is a popular herb and is medically lauded for ameliorating myriad symptoms associated with menopause. However, its pharmaceutical limitations and non-availability of a patient-compliant drug delivery approach have precluded its prevalent use. Henceforth, the current research premise is aimed at developing an ethosomal gel incorporating triterpene enriched fraction (TEF) obtained from CR and evaluating its effectiveness through the transdermal application. TEF-loaded ethosomes were formulated using solvent injection, optimized and characterised. The optimized ethosomes were then dispersed into a polymeric gel base to form ethosomal gel which was further compared with the conventional gel by in-vitro and ex-vivo experiments. Here, the quality by design (QbD) approach was exploited for the optimization and development of ethosomal gel. The elements of QbD comprising initial risk assessment, design of experimentation (DoE), and model validation for the development of formulation have all been described in detail. The optimized ethosomes (F03) showed a nanometric size range, negative zeta potential and good entrapment. The in vitro release profile of gel revealed a burst release pattern following the Korsmeyer Peppas model having Fickian diffusion. The transdermal flux of ethosomal gel was observed to be more than that of conventional gel. Texture analysis and rheological characterization of the gel, revealed good strength showing shear thinning and pseudoplastic behaviour. The confocal microscope investigation revealed the deeper skin permeation of ethosomal gel than conventional gel. This result was further strengthened by DSC, IR and histological assessment of the animal skin (Wistar rat), treated with the optimized formulation. Conclusively, the implementation of QbD in the formulation resulted in a better understanding of the process and the product. It aids in the reduction of product variability and defects, hence improving product development efficiencies. Additionally, the ethosomal gel was found to be a more effective and successful carrier for TEF than the conventional gel through the transdermal route. Moreover, this demands an appropriate animal study, which is underway, for a stronger outcome. Full article
(This article belongs to the Special Issue Novel Drug Delivery Systems for Women's Health)
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16 pages, 1926 KiB  
Article
Formulation and Optimization of Metronidazole and Lactobacillus spp. Layered Suppositories via a Three-Variable, Five-Level Central Composite Design for the Management of Bacterial Vaginosis
by Margaret O. Ilomuanya, Busayo B. Salako, Modupe O. Ologunagba, Omonike O. Shonekan, Kruga Owodeha-Ashaka, Eseosa S. Osahon and Andrew N. Amenaghawon
Pharmaceutics 2022, 14(11), 2337; https://doi.org/10.3390/pharmaceutics14112337 - 29 Oct 2022
Cited by 4 | Viewed by 1992
Abstract
Bacterial vaginosis, a polymicrobial clinical syndrome characterized by a shift in healthy vaginal microbiota due to bacterial colonization, is characterized by high recurrence rates after conventional treatment with an antimicrobial agent. This has necessitated the need to develop a formulation that has the [...] Read more.
Bacterial vaginosis, a polymicrobial clinical syndrome characterized by a shift in healthy vaginal microbiota due to bacterial colonization, is characterized by high recurrence rates after conventional treatment with an antimicrobial agent. This has necessitated the need to develop a formulation that has the potential to ensure Lactobacilli viability and bacterial clearance. This study seeks to develop and optimize a layered suppository using a five-level central composite design to ensure optimized metronidazole release and lactic acid viability. Layered suppositories were formulated using the fusion method using polyethylene glycol blend 1500/4000 and Ovucire® as suppository bases. Lactobacillus fermentum was incorporated in the molten mass before molding the solid body suppositories into the cavity of hollow-type suppositories and sealing the molten excipients. Artificial neural network model predictions for product optimization showed high predictive capacity, closely resembling experimental observations. The highest disintegration time recorded was 12.76 ± 0.37 min, with the optimized formulations showing lower times of 5.93 ± 0.98 min and an average weight of 1.17 ± 0.07 g. Histopathological observations determined high compatibility of suppositories with vaginal cells with no distortion or wearing of the vagina epithelium. This optimized formulation provides a safe and promising alternative to conventional suppositories in the treatment and prevention of the recurrence of bacterial vaginosis. Full article
(This article belongs to the Special Issue Novel Drug Delivery Systems for Women's Health)
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