Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Evaluation of the Physical-chemical Characteristics and Biopharmaceutical Performance of Dilu-Cap: A Complete Line of Excipients for Hard-shell Capsules

Author(s):  de Oliveira Ferreira Anderson, Polonini Hudson

Issue:  Jul/Aug 2022 - Volume 26, Number 4
View All Articles in Issue

Note:  Electronic version includes errata or revisions.

Abstract:  The development of an efficient formulation for hardshell capsules needs to consider pharmaceutical and biopharmaceutical aspects to assist in the careful selection of excipients, which are essential ingredients for the formulation’s good performance. They ensure correct bioavailability, solubility, stability, dose accuracy (weight variation and content uniformity), and organoleptic characteristics. Given this, DiluCap was developed as a line of excipients so that the pharmacist can compound every capsule formulation with ease and trust in its final characteristics. The line is composed of six excipients: 1) Dilucap SLD, for soluble active pharmaceutical ingredients Class I and III from the Biopharmaceutical Classification System – it promotes disintegration without a negative impact on dissolution; 2) Dilucap PSD, for poorly soluble active pharmaceutical ingredients Class II and IV – it favors the disintegration and dissolution of the active pharmaceutical ingredients; 3) Dilucap SR, for active pharmaceutical ingredients requiring modified/ slow release – it reduces the disintegration and release rate of the active pharmaceutical ingredients, promoting its slow release, and, also, prevents plasma peaks responsible for adverse effects; 4) DiluCap Hygro, for hygroscopic or deliquescent active pharmaceutical ingredients – it reduces hygroscopicity, deliquescence, and eutectic mixture formation; 5) DiluCap Antioxi, for active pharmaceutical ingredients susceptible to oxidation – it provides chemical stabilization due to antioxidant ingredients and reduces water activity and chemical degradation; 6) DiluCap OD, for orodispersible active pharmaceutical ingredients that can be compounded as sprinkle capsules or sublingual capsules – it favors transmucosal permeation. The testing conducted for the DiluCap line of excipients showed that all products have suitable flow properties (angle of repose and Carr’s compressibility index), hygroscopicity, biopharmaceutical performance (dissolution profiles), and stability. This corroborates the allegations that DiluCap provides a science based line of excipients to the compounding pharmacies with proven functionality that saves time (reduces the preprocessing and the number of items in stock) and guarantees efficacy and safety of hard-shell oral capsules formulations.

Related Keywords: Anderson de Oliveira Ferreira, BPharm, MSc, PhD, Hudson Polonini, BPharm, MSc, PhD, hard-shell capsules, excipients, bioavailability, solubility, stability, dose accuracy, DiluCap, disintegration, drug release rate, hygroscopicity, deliquescence, chemical stability, orodispersible, transmucosal permeation, dissolution profile, Biopharmaceutical Classification System, gastrointestinal permeability, modified-release capsules, slow-release capsules, powder flow properties, angle of repose, Carr compressibility index


Printer-Friendly Version

Download in electronic PDF format for $55

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Evaluation of the Physical-chemical Characteristics and Biopharmaceutical Performance of Dilu-Cap: A Complete Line of Excipients for Hard-shell Capsules de Oliveira Ferreira Anderson, Polonini Hudson Jul/Aug 2022 283-291 Buy
Stability of Alprazolam, Atropine Sulfate, Glutamine, Levofloxacin, Metoprolol Tartrate, Nitrofurantoin, Ondansetron Hydrochloride, Oxandrolone, Pregabaline, and Riboflavin in SyrSpend SF pH4 Oral Suspensions de Oliveira Ferreira Anderson, Polonini Hudson C, Loures da Silva Sharlene, Cerqueira de Melo Victor Augusto, de Andrade Laura, Fernandes Brandão Marcos Antônio May/Jun 2017 255-263 Buy
Always the Right Dose? Content Uniformity in Over 100 Different Formulations Tested Dijkers Eli, Polonini Hudson, de Oliveira Ferreira Anderson Sep/Oct 2020 408-412 Buy
Compatibility of Gestrinone, Nimesulide, and Piroxicam in Pentravan for Transdermal and Transmucosal Application Polonini Hudson, de Oliveira Ferreira Anderson, Dijkers Eli Sep/Oct 2021 422-426 Buy
Stability of Acetazolamide, Baclofen, Dipyridamole, Mebeverine Hydrochloride, Propylthiouracil, Quinidine Sulfate, and Topiramate Oral Suspensions in SyrSpend SF PH4 de Oliveira Ferreira Anderson, Polonini Hudson, Loures da Silva Sharlene, Buzinari Aglio Natália Cristina, Abreu Jordana, Fernandes Brandão Marcos Antônio Jul/Aug 2017 339-346 Buy
The Influence of Tablet Formulation, Drug Concentration, and pH Modification on the Stability of Extemporaneously Compounded Levothyroxine Suspensions Svirskis Darren, Lin Shao-Wei, Brown Helen, Sangaroomthong Annie, Shin Daniel, Wang Ziqi, Xu Hongtao, Dean Rebecca, Vareed Preetika, Jensen Maree, Wu Zimei Mar/Apr 2018 164-171 Buy
Compounded Orodispersible Films with Natural Ingredients for Halitosis: A Clinical Experience Apolinário Régis De Souza, Chaves Maria Das Graças Afonso Miranda, Gonçalves Hanny Reis Mockdeci, Martins Isadora Conde Ferreria, De Paula Renée Mazilão, Granato Ana Paula Alves, Polonini Hudson Caetano, Brandão Marcos Antônio Fernandes, Ferreira Anderson De Oliveira, Raposo Nádia Rezende Barbosa Nov/Dec 2018 512-515 Buy
Compatibility of Baclofen, Carvedilol, Hydrochlorothiazide, Mercaptopurine, Methadone Hydrochloride, Oseltamivir Phosphate, Phenobarbital, Propranolol Hydrochloride, Pyrazinamide, Sotalol Hydrochloride, Spironolactone, Tacrolimus Monohydrate, Ursodeoxycholic Acid, and Vancomycin Hydrochloride Oral Suspensions Compounded with SyrSpend SF pH4 Polonini Hudson, da Silva Sharlene Loures, Brandão Marcos Antônio Fernandes, Bauters Tiene, De Moerloose Barbara, Ferreira Anderson de Oliveira Nov/Dec 2018 516-526 Buy
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 154-163 Buy
Stability of Allopurinol, Amitriptyline Hydrochloride, Carbamazepine, Domperidone, Isoniazid, Ketoconazole, Lisinopril, Naproxen, Paracetamol (Acetaminophen), and Sertraline Hydrochloride in SyrSpend SF PH4 Oral Suspensions Polonini Hudson C, Loures Sharlene, de Araujo Edson Peter, Brandão Marcos Antônio F, Ferreira Anderson O Sep/Oct 2016 426-434 Buy