Estimating Shelf Life Through Tolerance Intervals.

Abstract:

:This paper is a continuation of the research published by the Stability Shelf Life Working Group as chartered under the Product Quality Research Institute. The Working Group was formed in 2006 and disbanded in late 2019. Following the philosophy presented by the Working Group on how to characterize the stability shelf life paradigm (Capen et al., 2012), shelf life is estimated here in terms of defining risk as a specified proportion of the pharmaceutical stability distribution of interest being out of specification. Shelf life can be defined for the batch mean distribution for regulatory issues, as well as for the product distributions for patient interests. Estimates of shelf life are proposed corresponding to each stability distribution through the use of statistical tolerance intervals. Appropriate estimates of the between-batch and within-batch variance components are obtained through a random coefficient mixed regression model analysis based on the best fit to batch stability response data. Tolerance interval estimates are computed as part of the mixed model analysis and computed directly using the statistical definition of the stability distributions. A proposed rationale is offered on how to select an appropriate proportion allowed out of specification to define a meaningful shelf life. Examples of the proposed shelf life estimates are presented using industry stability batch data. For each example, the traditional ICH shelf life estimate is given for comparison.

journal_name

AAPS PharmSciTech

journal_title

AAPS PharmSciTech

authors

Schwenke J,Quinlan M,Stroup W,Forenzo P

doi

10.1208/s12249-020-01800-2

subject

Has Abstract

pub_date

2020-10-20 00:00:00

pages

290

issue

8

issn

1530-9932

pii

10.1208/s12249-020-01800-2

journal_volume

21

pub_type

杂志文章
  • Pore direction in relation to anisotropy of mechanical strength in a cubic starch compact.

    abstract::The purpose of this research was to evaluate the relation between preferential direction of pores and mechanical strength of cubic starch compacts. The preferential pore direction was quantified in SEM images of cross sections of starch compacts using a previously described algorithm for determination of the quotient ...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-008-9074-4

    authors: Wu YS,van Vliet LJ,Frijlink HW,Stokroos I,van der Voort Maarschalk K

    更新日期:2008-01-01 00:00:00

  • Sustained Release of Poorly Water-Soluble Drug from Hydrophilic Polymeric Film Sandwiched Between Hydrophobic Layers.

    abstract::This proof-of-concept study explores the feasibility of using a drug-loaded hydrophilic polymeric layer sandwiched between two hydrophobic layers for improving film drug load while achieving sustained release of poorly water-soluble drug. Such films having total thickness in range ~ 146-250 μm were prepared by slurry-...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-018-1089-x

    authors: Kevadiya BD,Zhang L,Davé RN

    更新日期:2018-08-01 00:00:00

  • Rheological characterization of neutral and anionic polysaccharides with reduced mucociliary transport rates.

    abstract::The purpose of this research was to compare the viscoelastic properties of several neutral and anionic polysaccharide polymers with their mucociliary transport rates (MTR) across explants of ciliated bovine tracheal tissue to identify rheologic parameters capable of predicting the extent of reduction in mucociliary tr...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/pt0802032

    authors: Shah AJ,Donovan MD

    更新日期:2007-04-20 00:00:00

  • Exploring Microstructural Changes in Structural Analogues of Ibuprofen-Hosted In Situ Gelling System and Its Influence on Pharmaceutical Performance.

    abstract::The present work explores inner structuration of in situ gelling system consisting of glyceryl monooleate (GMO) and oleic acid (OA). The system under study involves investigation of microstructural changes which are believed to govern the pharmaceutical performance of final formulation. The changes which are often ter...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-015-0308-y

    authors: Patil SS,Venugopal E,Bhat S,Mahadik KR,Paradkar AR

    更新日期:2015-10-01 00:00:00

  • Mechanical Characterization and Dissolution of Chewing Gum Tablets (CGTs) Containing Co-compressed Health in Gum® and Curcumin/Cyclodextrin Inclusion Complex.

    abstract::Curcumin chewing gums could be therapeutically beneficial if used by the head and neck cancer patients. High curcumin loading in chewing gums however is needed to achieve desired therapeutic effect. Preparing gums with high drug load is nonetheless challenging because of the negative impact of solids on their masticat...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-018-1174-1

    authors: Al Hagbani T,Altomare C,Kamal MM,Nazzal S

    更新日期:2018-11-01 00:00:00

  • Development and characterization of sorbitan monostearate and sesame oil-based organogels for topical delivery of antimicrobials.

    abstract::The current study explains the development of sorbitan monostearate and sesame oil-based organogels for topical drug delivery. The organogels were prepared by dissolving sorbitan monostearate in sesame oil (70°C). Metronidazole was used as a model antimicrobial. The formulations were characterized using phase contrast...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-014-0223-7

    authors: Singh VK,Pramanik K,Ray SS,Pal K

    更新日期:2015-04-01 00:00:00

  • Influence of formulation and processing variables on properties of itraconazole nanoparticles made by advanced evaporative precipitation into aqueous solution.

    abstract::Nanoparticles, of the poorly water-soluble drug, itraconazole (ITZ), were produced by the Advanced Evaporative Precipitation into Aqueous Solution process (Advanced EPAS). This process combines emulsion templating and EPAS processing to provide improved control over the size distribution of precipitated particles. Spe...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-012-9817-0

    authors: Bosselmann S,Nagao M,Chow KT,Williams RO 3rd

    更新日期:2012-09-01 00:00:00

  • Mathematical modeling of an aqueous film coating process in a Bohle Lab-Coater: part 2: application of the model.

    abstract::For the prediction of the air and product temperatures, the product moisture, and the air humidity during a coating process in a Bohle Lab-Coater, a model was developed. The purpose of this work was to determine the limit moisture, the critical moisture, and the constant for the exchange rate between both zones and to...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/pt070243

    authors: Page S,Baumann KH,Kleinebudde P

    更新日期:2006-05-05 00:00:00

  • Development of Orodispersible Films Containing Benzydamine Hydrochloride Using a Modified Solvent Casting Method.

    abstract::The aim of this study was to develop benzydamine hydrochloride-loaded orodispersible films using the modification of a solvent casting method. An innovative approach was developed when the drying process of a small-scale production was used based on a heated inert base for casting the film. During this process, two ty...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-018-1088-y

    authors: Pechová V,Gajdziok J,Muselík J,Vetchý D

    更新日期:2018-08-01 00:00:00

  • Characterization and evaluation of 5-fluorouracil-loaded solid lipid nanoparticles prepared via a temperature-modulated solidification technique.

    abstract::The aim of this research was to advance solid lipid nanoparticle (SLN) preparation methodology by preparing glyceryl monostearate (GMS) nanoparticles using a temperature-modulated solidification process. The technique was reproducible and prepared nanoparticles without the need of organic solvents. An anticancer agent...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-014-0168-x

    authors: Patel MN,Lakkadwala S,Majrad MS,Injeti ER,Gollmer SM,Shah ZA,Boddu SH,Nesamony J

    更新日期:2014-12-01 00:00:00

  • Facile Synthesis of Chitosan Capped Mesoporous Silica Nanoparticles: A pH Responsive Smart Delivery Platform for Raloxifene Hydrochloride.

    abstract::An encapsulation of model drug raloxifene hydrochloride (RAL) inside the chitosan decorated pH responsive mesoporous system has a greater potential for accumulating in the tumor cells. The present study involves synthesis of surface modified mesoporous silica nanoparticles (MSN) with the aim of achieving pH sensitive ...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-017-0949-0

    authors: Shah PV,Rajput SJ

    更新日期:2018-04-01 00:00:00

  • Transdermal delivery of diclofenac sodium through rat skin from various formulations.

    abstract::The aim of this study was to evaluate and compare the in vitro and in vivo transdermal potential of w/o microemulsion (M) and gel (G) bases for diclofenac sodium (DS). The effect of dimethyl sulfoxide (DMSO) as a penetration enhancer was also examined when it was added to the M formulation. To study the in vitro poten...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/pt070488

    authors: Sarigüllü Ozgüney I,Yeşim Karasulu H,Kantarci G,Sözer S,Güneri T,Ertan G

    更新日期:2006-10-20 00:00:00

  • Acoustic-resonance spectrometry as a process analytical technology for rapid and accurate tablet identification.

    abstract::This research was performed to test the hypothesis that acoustic-resonance spectrometry (ARS) is able to rapidly and accurately differentiate tablets of similar size and shape. The US Food and Drug Administration frequently orders recalls of tablets because of labeling problems (eg, the wrong tablet appears in a bottl...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/pt070125

    authors: Medendorp J,Lodder RA

    更新日期:2006-03-01 00:00:00

  • In vitro-controlled release delivery system for hydrogen sulfide donor.

    abstract::Hydrogen sulfide (H2S) is having many potential pharmacological and physiological actions which reported that therapeutically useful concentration is low (100-160 μM) and a higher concentration could be toxic. Most of its donors produce it on coming into contact with water. All of these problems could be solved by a c...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-014-0117-8

    authors: Ali H,Opere C,Singh S

    更新日期:2014-08-01 00:00:00

  • A novel nanoparticle formulation for sustained paclitaxel delivery.

    abstract:PURPOSE:To develop a novel nanoparticle drug delivery system consisting of chitosan and glyceryl monooleate (GMO) for the delivery of a wide variety of therapeutics including paclitaxel. METHODS:Chitosan/GMO nanoparticles were prepared by multiple emulsion (o/w/o) solvent evaporation methods. Particle size and surface...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-008-9063-7

    authors: Trickler WJ,Nagvekar AA,Dash AK

    更新日期:2008-01-01 00:00:00

  • Investigation into stability of poly(vinyl alcohol)-based Opadry® II films.

    abstract::Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry® II ...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-011-9630-1

    authors: Koo OM,Fiske JD,Yang H,Nikfar F,Thakur A,Scheer B,Adams ML

    更新日期:2011-06-01 00:00:00

  • Research Progress of Drug Treatment in Novel Coronavirus Pneumonia.

    abstract::As of March 10, 2020, more than 100,000 novel coronavirus pneumonia cases have been confirmed globally. With the continuous spread of the new coronavirus pneumonia epidemic in even the world, prevention and treatment of the disease have become urgent tasks. The drugs currently being developed are not adequate to deal ...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章,评审

    doi:10.1208/s12249-020-01679-z

    authors: Yan J,Liu A,Huang J,Wu J,Fan H

    更新日期:2020-05-13 00:00:00

  • Effects of the Preparation Process on the Properties of Amorphous Solid Dispersions.

    abstract::The use of amorphous solid dispersions to improve the bioavailability of active ingredients from the BCS II and IV classifications continues to gain interest in the pharmaceutical industry. Over the last decade, methods for generating amorphous solid dispersions have been well established in commercially available pro...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章,评审

    doi:10.1208/s12249-017-0861-7

    authors: Huang S,Williams RO 3rd

    更新日期:2018-07-01 00:00:00

  • Drug-Smectite Clay Amorphous Solid Dispersions Processed by Hot Melt Extrusion.

    abstract::The aim of this study was to introduce smectite clay matrices as a drug delivery carrier for the development of amorphous solid dispersions (ASD). Indomethacin (IND) was processed with two different smectite clays, magnesium aluminium and lithium magnesium sodium silicates, using hot melt extrusion (HME) to prepare so...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-020-01813-x

    authors: Nandi U,Mithu MSH,Hurt AP,Trivedi V,Douroumis D

    更新日期:2020-10-08 00:00:00

  • Development of Methotrexate and Minocycline Loaded Nanoparticles for the Effective Treatment of Rheumatoid Arthritis.

    abstract::Rheumatoid arthritis is an autoimmune disease that leads to cartilage destruction, synovial joint inflammation, and bacterial joint/bone infections. In the present work, methotrexate and minocycline-loaded nanoparticles (MMNPs) were developed with an aim to provide relief from inflammation and disease progression/join...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-019-1581-y

    authors: Janakiraman K,Krishnaswami V,Sethuraman V,Natesan S,Rajendran V,Kandasamy R

    更新日期:2019-12-23 00:00:00

  • Microemulsion-based oxyresveratrol for topical treatment of herpes simplex virus (HSV) infection: physicochemical properties and efficacy in cutaneous HSV-1 infection in mice.

    abstract::The physicochemical properties of the optimized microemulsion and the permeating ability of oxyresveratrol in microemulsion were evaluated, and the efficacy of oxyresveratrol microemulsion in cutaneous herpes simplex virus type 1 (HSV-1) infection in mice was examined. The optimized microemulsion was composed of 10% w...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-012-9828-x

    authors: Sasivimolphan P,Lipipun V,Ritthidej G,Chitphet K,Yoshida Y,Daikoku T,Sritularak B,Likhitwitayawuid K,Pramyothin P,Hattori M,Shiraki K

    更新日期:2012-12-01 00:00:00

  • Spray-Dried Succinylated Soy Protein Microparticles for Oral Ibuprofen Delivery.

    abstract::The potential value of succinylated soy protein (SPS) as a wall material for the encapsulation of ibuprofen (IBU), a model hydrophobic drug, by spray-drying was investigated. A succinylation rate of 93% was obtained for soy protein isolate, with a molar ratio of 1/1.5 (NH2/succinic anhydride). The solubility profile a...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-018-1250-6

    authors: Anaya Castro MA,Alric I,Brouillet F,Peydecastaing J,Fullana SG,Durrieu V

    更新日期:2019-01-11 00:00:00

  • New insights into the pelletization mechanism by extrusion/spheronization.

    abstract::Pellet manufacturing by extrusion/spheronization is quite common in the pharmaceutical field because the obtained product is characterized by a high sphericity as well as a narrow particle size distribution. The established mechanisms only consider deformation of the initially fractured particles but do not account fo...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-010-9532-7

    authors: Koester M,Thommes M

    更新日期:2010-12-01 00:00:00

  • Emerging freeze-drying process development and scale-up issues.

    abstract::Although several guidelines do exist for freeze-drying process development and scale-up, there are still a number of issues that require additional attention. The objective of this review article is to discuss some emerging process development and scale-up issue with emphasis on effect of load condition and freeze-dry...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章,评审

    doi:10.1208/s12249-011-9599-9

    authors: Patel SM,Pikal MJ

    更新日期:2011-03-01 00:00:00

  • Formulation Optimization of Selective Laser Sintering 3D-Printed Tablets of Clindamycin Palmitate Hydrochloride by Response Surface Methodology.

    abstract::The aims of the current study were to develop and evaluate clindamycin palmitate hydrochloride (CPH) 3D-printed tablets (printlets) manufactured by selective laser sintering (SLS). Optimization of the formulation was performed by studying the effect of formulation and process factors on critical quality attributes of ...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-020-01775-0

    authors: Mohamed EM,Barakh Ali SF,Rahman Z,Dharani S,Ozkan T,Kuttolamadom MA,Khan MA

    更新日期:2020-08-13 00:00:00

  • Application of near-infrared spectroscopy in real-time monitoring of product attributes of ribbed roller compacted flakes.

    abstract::This study assessed the utility of near-infrared (NIR) spectroscopy for the real-time monitoring of content uniformity and critical quality attributes (tensile strength, Young's modulus, and relative density) of ribbed roller compacted flakes made by axially corrugated or ribbed rolls. A custom-built setup was used to...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-012-9890-4

    authors: Samanta AK,Karande AD,Ng KY,Heng PW

    更新日期:2013-03-01 00:00:00

  • Polymeric micelles of PEG-PE as carriers of all-trans retinoic acid for stability improvement.

    abstract::The topical application of all-trans retinoic acid (ATRA) is an effective treatment for several skin disorders, including photo-aging. Unfortunately, ATRA is susceptible to light, heat, and oxidizing agents. Thus, this study aimed to investigate the ability of polymeric micelles prepared from polyethylene glycol conju...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-011-9749-0

    authors: Wichit A,Tangsumranjit A,Pitaksuteepong T,Waranuch N

    更新日期:2012-03-01 00:00:00

  • Temperature-tunable iron oxide nanoparticles for remote-controlled drug release.

    abstract::Herein, we report the successful development of a novel nanosystem capable of an efficient delivery and temperature-triggered drug release specifically aimed at cancer. The water-soluble 130.1 ± 0.2 nm iron oxide nanoparticles (IONPs) were obtained via synthesis of a monodispersed iron oxide core stabilized with tetra...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-014-0131-x

    authors: Dani RK,Schumann C,Taratula O,Taratula O

    更新日期:2014-08-01 00:00:00

  • Preparation and physicochemical characterization of dioctyl sodium sulfosuccinate (aerosol OT) microemulsion for oral drug delivery.

    abstract::The performance of dioctyl sodium sulfosuccinate (aerosol OT) in the development of a pharmaceutically acceptable, stable, self-emulsifying water continuous microemulsion with high dilution efficiency was assessed. A pseudoternary microemulsion system was constructed using aerosol OT/medium-chain triglycerides with ol...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/pt040111

    authors: El-Laithy HM

    更新日期:2003-01-01 00:00:00

  • Development of acid-resistant alginate/trimethyl chitosan nanoparticles containing cationic β-cyclodextrin polymers for insulin oral delivery.

    abstract::In this study, the use of trimethylchitosan (TMC), by higher solubility in comparison with chitosan, in alginate/chitosan nanoparticles containing cationic β-cyclodextrin polymers (CPβCDs) has been studied, with the aim of increasing insulin uptake by nanoparticles. Firstly, TMCs were synthesized by iodomethane, and C...

    journal_title:AAPS PharmSciTech

    pub_type: 杂志文章

    doi:10.1208/s12249-014-0282-9

    authors: Mansourpour M,Mahjub R,Amini M,Ostad SN,Shamsa ES,Rafiee-Tehrani M,Dorkoosh FA

    更新日期:2015-08-01 00:00:00