Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

Stability Evaluation of Minoxidil in FOAMIL Form Base with Bracketing Study Design

Author(s):  Lupatini Rodrigo, Sidhu Raman, Patel Harshad, Bichar Katia

Issue:  May/Jun 2021 - Volume 25, Number 3
View All Articles in Issue

Page(s):  236-240

Stability Evaluation of Minoxidil in FOAMIL Form Base with Bracketing Study Design Page 1
Stability Evaluation of Minoxidil in FOAMIL Form Base with Bracketing Study Design Page 2
Stability Evaluation of Minoxidil in FOAMIL Form Base with Bracketing Study Design Page 3
Stability Evaluation of Minoxidil in FOAMIL Form Base with Bracketing Study Design Page 4
Stability Evaluation of Minoxidil in FOAMIL Form Base with Bracketing Study Design Page 5

Download in electronic PDF format for $75

Abstract:  Topical minoxidil is a common medication prescribed for treating hair loss-related problems. Currently a wide range of minoxidil concentrations (2% to 15%) have been prescribed for the topical treatment of hair loss, but the majority of minoxidil solutions contain potential skin irritating inactive ingredients such as propylene glycol and high amounts of alcohol that may cause undesirable side effects. In order to minimize these side effects, FOAMIL, a propylene glycol-free and alcohol-reduced foam vehicle, was developed to compound minoxidil solutions of varying dosages. Since long-term use of this drug is necessary to maintain the clinical results, the objective of this study was to conduct a 180-day bracketed validated stability-indicating study of four compounded minoxidil solutions (2%, 5.5%, 6%, 15%) in FOAMIL. The samples were prepared by mixing the minoxidil with an appropriate amount of FOAMIL without any heating or filtration process. The obtained preparations were packaged into 100-mL foamer bottles before sending out for physicochemical analyses at pre-determined time points (days; 0, 30, 60, 90, 120, 150, and 180) and antimicrobial effectiveness testing to thirdparty independent analytical laboratories. Our results showed that the strength of all minoxidil solutions remained within the United States Pharmacopeia specification (90% to 110%) for 180 days. There were no significant changes in pH measurements and physical stability (color, odor, precipitation). Antimicrobial effectiveness of the preservative system also met the United States Pharmacopeia requirements at the end of the 180-day stability study for all concentrations. Based on the U.S. Food and Drug Administration’s guidance on bracketed study design, the findings of this study show that any concentration of minoxidil at or between 2% to 5.5% and 6% to 15% in FOAMIL can be considered stable for at least 180 days when stored at ambient condition.

Related Keywords: Rodrigo Lupatini, MSc, Raman Sidhu, BSc, Harshad Patel, BSc, Katia Bichar, BSc, minoxidil, piperidinopyrimidine derivative, potassium channel opener, vasodilator, hypertension, hypertrichosis, hair loss, hair growth, androgenetic alopecia, male pattern baldness, topical preparation, foam dosage form, men, contact dermatitis, allergenic excipients, stability, foam vehicle

Related Categories: DERMATOLOGY, EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, CARDIOLOGY, DOSAGE FORMS/DRUG CARRIERS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Stability Evaluation of Minoxidil in FOAMIL Form Base with Bracketing Study Design
Lupatini Rodrigo
, Sidhu Raman, Patel Harshad, Bichar Katia
May/Jun 2021
Pg. 236-240

Formulation, Physical Stability, and the Clinical Effectiveness of Extemporaneous Ivermectin Oral Solution
Zaid Abdel-Naser
, Zaaror Yara Abu, Qaddumi Aiman, Ratrout Ala, Ahmad Ayda, Hamad Emad, Kittana Naim
Nov/Dec 2021
Pg. 523-527

Highlighting the Benefits of AlpaWash in Wound Care: Case Reports in Small Animals
Semighini Flavia
, Fornaciari Lais de Azevedo, Pinheiro Vanessa, Lupatini Rodrigo, Haiub Halema, Cull Erica, Sidhu Raman
Nov/Dec 2023
Pg. 454-460

Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates)
Brandin Thibaut
, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice
Mar/Apr 2022
Pg. 150-154

Evaluation and Comparison of Wound Healing Properties of an Ointment (AlpaWash) Containing Brazilian Micronized Propolis and Peucedanum ostruthium Leaf Extract in Skin Ulcer in Rats
Nani Marcel
, Leone Andréia, Bom Vinícius Pedro, Buszinski Andrei Felipe, Oliveira de Souza Rebeca, Pinheiro Vanessa Alves, Danapoulos Panagiota, Swikidisa Rosita, Marquele-Oliveira Franciane, Cipriani Frade Marco Andrey, Berretta Andresa Aparecida, Nogueira Rodrigo José Lupatini
Mar/Apr 2018
Pg. 154-163

Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design
Patel Gopesh
, Davis Countaney, Liu Yi, Ip Kendice, Debideen Krystal E, Anderson Stephanie, Byrne Robert, Herr Dylan, Rhoads Melissa Merrell, Caputo Ross, Banov Daniel, Bassani August S
Jan/Feb 2021
Pg. 73-81

Case Report of Anal Fissures and Hemorrhoids Treated with Compounded Cromolyn Sodium and Naltrexone Hydrochloride in MEDISCA's SPG SUPPOSI-BASE
Earlywine Kerry
, Haiub Halema, Cull Erica, Lupatini Rodrigo, Sidhu Raman
Jan/Feb 2023
Pg. 6-10

Stability of Venlafaxine Immediate-Release Suspensions
Donnelly Ronald F
, Wong Keith, Goddard Rob, Johanson Christel
Jan/Feb 2011
Pg. 81-84

Stability of Minoxidil in Espumil Foam Base
Geiger Christine M
, Sorenson Bridget, Whaley Paul A
Mar/Apr 2013
Pg. 165-167

Case Report in Equine: Highlighting the Benefits of Medisca CopaSil in Burn Scar Management
Heuerman Jason
, Haiub Halema, Cull Erica, Lupatini Rodrigo, Shrum Brandon, Sidhu Raman
Jul/Aug 2023
Pg. 270-276

Stability of Compounded Topical Nifedipine in Cream, Gel, and Ointment Bases
Teimouri Arezou
, Yeung Pollen, Agu Remigius U
Jul/Aug 2021
Pg. 344-351

Minoxidil 50 mg/mL in Espumil Foam Base
Allen Loyd V Jr
Jul/Aug 2018
Pg. 322

In Vitro Evaluation of Extemporaneously Compounded Immediate-release Capsules with Premixed Excipients, Based on the Biopharmaceutics Classification System (BCS) of the Drugs
Pinheiro Vanessa A
, Danopoulos Panagiota, Demirdjian Lara, Nogueira Rodrigo J L, Dubois Fanny
Sep/Oct 2013
Pg. 424-431

Stability of Prednisone in Oral Mix Suspending Vehicle
Friciu Mihaela
, Plourde Kevin, Leclair Grégoire, Danapoulos Panagiota, Savji Taslim
Jul/Aug 2015
Pg. 337-339

Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump
Tomasello Cristina
, Leggieri Anna, Rabbia Franco, Veglio Franco, Baietto Lorena, Fulcheri Chiara, De Nicolò Amedeo, De Perri Giovanni, D'Avolio Antonio
Jul/Aug 2016
Pg. 343-346

Minoxidil 1-mg/mL in Ora-Plus and Ora-Sweet SF Suspension
Allen Loyd V Jr
Jan/Feb 2019
Pg. 57

Stability of Compounded Diltiazem Hydrochloride in Cream, Ointment, and Gel Formulations for Topical Use
Teimouri Arezou
, Yeung Pollen, Agu Remigius U
Nov/Dec 2020
Pg. 482-490

Drug-release Assessment of Compounded Topical Nifedipine and Diltiazem in Commonly Used Bases for Wound Healing
Teimouri Arezou
, Yeung Pollen, Agu Remigius U
Nov/Dec 2020
Pg. 501-508

Extemporaneous Topical Minoxidil Solutions for the Treatment of Alopecia: Stability Studies and Incorporation Tests of Active Ingredients in ALOPLUS FAST Base
Spennacchio Antonio
, Lopedota Angela Assunta, Lopalco Antonio, Dibenedetto Maria Teresa, la Forgia Flavia Maria, Fontana Sergio, Franco Massimo, Denora Nunzio
May/Jun 2023
Pg. 256-262

Evaluation of the Antibacterial Activity of Green Propolis Extract and Meadowsweet Extract Against Staphylococcus aureus Bacteria: Importance in Would Care Compounding Preparations
Lupatini Nogueira Rodrigo José
, Danopoulos Panagiota, Swikidisa Rosita, Alves Pinheiro Vanessa
Jul/Aug 2016
Pg. 333-337

Return to Top