Effects of Prosochit® Binder on the Dissolution and Permeation of a BCS Class IV Drug doi.org/10.26538/tjnpr/v5i6.26
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Abstract
Prosochit® (PC) is a novel excipient available in variants: Prosochit® 201, 101 and 102 having varying binding and performance-modifying properties. This study investigates the effects of the different types of Prosochit® on the dissolution and permeation of hydrochlorothiazide, a BCS class IV drug. Compatibility of Prosochit® with hydrochlorothiazide was investigated using Fourier Transform Infrared Spectroscopy (FTIR). Six batches of hydrochlorothiazide tablets were formulated by wet granulation; batches F1 to F3 containing 3% PC201, PC101 and PC102 respectively and batches F4 to F6 containing 6% PC201, PC101 and PC102 respectively. The release properties of the tablets and the intestinal permeability of the drug were studied in comparison with a marketed product. The FTIR spectra revealed no adverse interaction between Prosochit® and hydrochlorothiazide. The cumulative amount of drug released in 1 h was in the order: marketed product > F1 > F2 > F6 > F3 > F5 > F4. Even though the test tablets exhibited low dissolution rates, substantial amounts of the drug were eventually released after 1 h to enable adequate permeation of the drug. The test tablets were characterized by better permeation profiles compared to the marketed product; and batch F1 which contains 3% PC201 was characterized by a markedly high amount of drug permeated in 5 h. Of the Prosochit® types and concentrations investigated, 3% PC201 is the most suitable binder for optimizing the dissolution and permeation of hydrochlorothiazide.
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References
Debotton N and Dahan A. Application of polymers as pharmaceutical excipients in solid oral dosage forms. Med Res Rev. 2017; 37(1):52-97.
Olorunsola EO, Akpabio EI, Adedokun MO, Ajibola DO. Emulsifying properties of hemicelluloses. In: Karakus S (Ed.). Science and Technology behind Nanoemulsions. London: IntechOpen; 2018. 29-42 p.
Ibrahim HM and El-Zairy EMR. Chitosan as a biomaterial: Structure, properties and elecrospun nanofibers. In: Bobbarala V
(Ed.). Concepts, Compounds and the Alternatives of Antibacterials. London: IntechOpen; 2015. 81-101 p.
Olorunsola EO. Prosochit: A group of multi-functional pharma excipients. Nigerian Patent NG/P/2016/355; 2017. 14 p.
Olorunsola EO, Tologbonse AA, Onwuka NA, Adikwu MU. Enhanced oral delivery of artemether: An application of Prosochit®
. J Appl Pharm Sci. 2019; 9(4):133-136.
Herman LL and Bashir K. Hydrochlorothiazide. Treasure Island, Florida: StatPearls Publishing; 2019. PMID: 28613517.
Bolland MJ, Ames RW, Horne AM, Orr-Walker BJ, Gamble JD, Reid IR. The effect of treatment with a thiazide diuretic for 4
years on bone density in normal postmenopausal women. Osteoporos Int. 2007; 18(4):479-486.
Balaei F and Ghobadi S. Hydrochlorothiazide binding to human serum albumin induces some compactness in the molecular
structure of protein: A multi-spectroscopic and computational study. J Pharm Biomed Anal. 2019; 162:1-8.
Samphui P, Devi VK, Clara D, Malviya N, Ganguly S, Desiraju GR. Cocrystals of hydrochlorothiazide: Solubility and diffusion/permeability enhancement through drug-coformer interactions. Mol Pharm. 2015; 12(5):1615-1622.
Amidol GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of
in-vitro drug product dissolution and in-vivo bioavailability. Pharm Res. 1995; 12:413-420.
Olorunsola EO and Majekodunmi SO. Development of extendedrelease formulation of domperidone using a blend of aphia
hookeri gum and hydroxypropyl methylcellulose as tablet matrix. Trop J Pharm Res. 2017; 16(10):2341-2347.
Masmoudi S, Faouzi MA, Meddah B, Elbarge M, Bouayad H, Cherrah Y, Bouklouze A. Inclusion complex of hydrochlorothiazide-Ɣ-cyclodextrin: The effect on aqueous solubility, dissolution rate, bioavailability and the effect on intestinal permeability using Using chamber technique. Int J Pharm Pharm Sci. 2003; 5(suppl 3):718-724.
Sharma N, Kulkarni GT, Sharma A. Development of novel Abelmoschus esculentus (Okra)-based mucoadhesive gel for
nasal delivery of rizatriptan benzoate. Trop J Pharm Res. 2013; 12(2):149-153.
Coutts RT. Infrared spectroscopy. In: Chatten LG (Ed.). Pharmaceutical Chemistry - Instrumental Techniques. New Delhi India: CBS Publishers and Distributors PVT Ltd; 2008. 59-125 p.
Attama AA, Adikwu MU, Okoli N. Studies in bioadhesive granules 1: Granules formulated with Prosopis africana gum. Chem Pharm Bull. 2000; 48(5):734-737.
Olorunsola EO, Akpan GA, Adikwu MU. Evaluation of chitosan-microcrystalline cellulose blends as direct compression excipients. J Drug Deliv. 2017; Article 8563858:1-8.
Saha S and Shahiwala AF. Multifunctional co-processed excipients for improved tableting performance. Expert Opin Drug Deliv. 2009; 6(2):197-208.
Gohel MC and Jogani FD. A review of co-processed directly compressible excipients. J Pharm Pharm Sci. 2005; 8(1):6-93.
Gangurde A, Patole RK, Sav AK, Amin PD. A novel directly compressible co-processed excipient for sustained release
formulation. J Appl Pharm Sci. 2013; 3(9):89-97.
Patel SS and Patel MM. Development of directly compressible excipients for dispersible tablets using 32 full factorial design. Int J Pharm Pharm Sci. 2009; 1:125-128.
Siraj SN, Kausar SH, Khan GJ, Khan T. Formulation and evaluation of oral fast dissolving tablet of ondansetron hydrochloride by co-processed excipients. J Drug Deliv Ther. 2017; 7(5):102-108.
Chaudhari PD, Phatak AA, Desai UA. A review: Co-processed excipients – an alternative to novel chemical entities. Int J Pharm
Chem Sci. 2012; 1(4):1480-1498.