Transdermal Product Formulation Development

Miller, Kenneth J.

doi:10.1002/9781118140505.ch15

Cited by 6 publications

(5 citation statements)

References 8 publications

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“…The commercial success of transdermal drug delivery patches commenced in 1980 with the first commercial scopolamine patch to treat motion sickness [16]. Today drug delivery via skin is still an attractive delivery technology as witnessed by the number of product approvals in 2014.…”

Section: Silicones In Transdermal Drug Deliverymentioning

confidence: 99%

“…Topical formulations use a variety of polymeric materials as matrices including petrolatum, acrylic polymers, cellulose derivatives, chitosan, carageenan and silicones [15]. In transdermal patch formulations, the polymeric pressure sensitive adhesive (PSA) material is a key component, creating a bond between skin and product and impacting all other performance criteria [16]. Three PSA chemistries are commonly used in transdermal products, namely acrylic, silicone and synthetic or natural rubber [16].…”

mentioning

confidence: 99%

“…In transdermal patch formulations, the polymeric pressure sensitive adhesive (PSA) material is a key component, creating a bond between skin and product and impacting all other performance criteria [16]. Three PSA chemistries are commonly used in transdermal products, namely acrylic, silicone and synthetic or natural rubber [16].…”

mentioning

confidence: 99%

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Recent Developments in Silicones for Topical and Transdermal Drug Delivery

Aliyar

Schalau

2015

Ther. Deliv.

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Silicones have been used in medicines, cosmetics and medical devices for over 60 years. Polydimethylsiloxanes are polymers that are typically used either as an active in oral drug products or as excipients in topical and transdermal drug products. Inherent characteristics like hydrophobicity, adhesion and aesthetics allow silicones to offer function and performance to drug products. Recent technologies like swollen crosslinked silicone elastomer blend networks, sugar siloxanes, amphiphilic resin linear polymers and silicone hybrid pressure sensitive adhesives promise potential performance advantages and improved drug delivery efficacy. This article presents a review of recent silicone material developments focusing on their function as excipients influencing drug delivery in topical and transdermal systems.

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Section: Silicones In Transdermal Drug Deliverymentioning

confidence: 99%

mentioning

confidence: 99%

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Recent Developments in Silicones for Topical and Transdermal Drug Delivery

Aliyar

Schalau

2015

Ther. Deliv.

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“…A pharmaceutical system that offers the passage of the drug through the skin to produce a systemic effect is termed a transdermal drug delivery system (TDDS). 1 It is one of the most promising drug conveying means due to its various advantages, such as offering continuous therapeutic effect from hours to days, avoiding frequent dosing, providing painless and easy administration, and ensuring minimal chances of toxic reactions. 2 , 3 These properties of TDDS provide improved patient compliance in long-term treatment especially for chronic pain and discontinuation of smoking.…”

Section: Introductionmentioning

confidence: 99%

Nanoclay-Based Composite Films for Transdermal Drug Delivery: Development, Characterization, and in silico Modeling and Simulation

Sikandar¹,

Shoaib²,

Yousuf³

et al. 2022

IJN

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Purpose Halloysite nanotubes (HNTs) are a versatile and highly investigated clay mineral due to their natural availability, low cost, strong mechanical strength, biocompatibility, and binding properties. The present work explores its role for retarding and controlling the drug release from the composite polymer matrix material. Methods For this purpose, nanocomposite films comprising propranolol HCl and different concentrations of HNTs were formulated using the “solution casting method”. The menthol in a concentration of 1% w/v was used as a permeation enhancer, and its effect on release and permeation was also determined. Quality characteristics of the nanocomposite were determined, and in vitro release and permeation studies were performed using the Franz diffusion system. The data was analyzed using various mathematical models and permeation parameters. Optimized formulation was also subjected to skin irritation test, FTIR, DSC, and SEM study. Systemic absorption and disposition of propranolol HCl from the nanocomposites were predicted using the GastroPlus TCAT® model. Results The control in drug release rate was associated with the higher concentration of HNTs. F8 released 50% of propranolol within 8 hours (drug, HNTs ratio, 1:2). The optimized formulation (F6) with drug: HNTs (2:1), exhibited drug release 80% in 4 hours, with maximum flux of 145.812 µg/cm 2 hr. The optimized formulation was found to be a non-irritant for skin with a shelf life of 35.46 months (28–30 ℃). The in silico model predicted C max , T max , AUC t , and AUC inf as 32.113 ng/mL, 16.58 h, 942.34 ng/mL×h, and 1102.9 ng/mL×h, respectively. Conclusion The study demonstrated that HNTs could be effectively used as rate controlling agent in matrix type transdermal formulations.

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“…At the same time, I was working on a paper which I eventually self-published with the title "Transdermal Product Development in the Age of QbD" [4]. In that paper, I present one workable development framework I refer to as DEWSI [5], but encouraged others to develop their own approaches for getting the greatest utility out of the QbD concepts. In developing an actual algorithm for how to select, organize and conduct experimental trials, I emphasized the need to balance the pre-defined activities of any plan and its ability to adapt to new results.…”

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Reconciling Quality by Design and Transdermal Product Development

Miller¹

2020

Pharmaceutics

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Since my first exposure to the acronym 'QbD' more than ten years ago, I have been trying to understand exactly what QbD is and how I might incorporate its teachings into my twenty-odd years of experience developing transdermal systems. I feel I have made little progress since then. Eventually, I came to realize that while QbD has its merits, it is not a guide for (transdermal) product development, despite so often being described as such. Instead, I have come to consider QbD as a language useful for organizing and presenting the array of data supporting the approval of a new product, but it still leaves the experimental approach entirely up to the developer. What QbD does provide to the development community is a means of conveying product information through a consistent framework facilitating both internal and regulatory review. As a result, new 'QbD' product applications tend to be more uniform and complete than the applications that preceded the initiative.

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Transdermal Product Formulation Development

Cited by 6 publications

References 8 publications

Recent Developments in Silicones for Topical and Transdermal Drug Delivery

Recent Developments in Silicones for Topical and Transdermal Drug Delivery

Nanoclay-Based Composite Films for Transdermal Drug Delivery: Development, Characterization, and in silico Modeling and Simulation

Reconciling Quality by Design and Transdermal Product Development

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