Evaluation of Carboxymethylated Plectranthus edulis Starch as Suspending Agent in Metronidazole Benzoate Suspension Formulation
DOI:
https://doi.org/10.37285/ijpsn.2019.12.5.8Abstract
Carboxymethylated Plectranthus edulis, Vatke (P. edulis) [fam., Lamiaceae] starch was evaluated as a suspending agent in metronidazole benzoate suspensions in comparison with sodium carboxymethyl cellulose (NaCMC) at concentration range of 1-4% (w/v). The resulting suspensions were evaluated for their sedimentation volume (%), degree of flocculation, rheology, redispersibility, and dissolution rate. Stability studies were performed for 3 months. The apparent viscosities of the formulations prepared with carboxymethylated P. edulis starch at reaction condition E (CMPS-E) was significantly lower than that of NaCMC (p < 0.05). The flowability of the suspensions, at all concentration levels of the suspending agents, were in the order of CMPS-E > NaCMC. AT 1% concentrations, carboxymethylated P. edulis starch (76 ± 1.5%) provided significantly higher (p < 0.05) sedimentation volume than NaCMC (40 ± 1.5%). At 3% and 4%, both gave comparable sedimentation volume (100%). Potassium dihydrogen phosphate (KH2PO4) employed as a flocculating agent significantly increased (p < 0.05) the sedimentation volume of the suspensions prepared with carboxy-methylated P.edulis starch and NaCMC. The redispersibilities of CMPS-E was better than those of NaCMC. All suspensions showed a release of greater than 85% of drug within 1 h. The results of stability studies showed that all suspension formulations were stable. From the foregoing, it can be concluded that carboxymethylated P. edulis starch could be used as an alternative suspending agent.
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Keywords:
Carboxymethylated, Plectranthus edulis, Sodium carboxymethyl cellulose, Suspending agent, Metronidazole
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Published
2019-09-30
How to Cite
1.
Brhane Y. Evaluation of Carboxymethylated Plectranthus edulis Starch as Suspending Agent in Metronidazole Benzoate Suspension Formulation. Scopus Indexed [Internet]. 2019 Sep. 30 [cited 2024 Dec. 22];12(5):4672-81. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/320
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Research Articles
References
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Asfaw Z, and Woldu Z (1997). Crop association of homegardens in Welayta and Gurage in Southern Ethiopia. SINET: Ethiop J Sci 20: 73-90.
Azam MG, and Haider SS (2008). Evaluation of dissolution behavior of paracetamol suspensions. Dhaka Univ J Pharm Sci 7: 53-58.
Boonme P, Phadoongsombut N, Phoomborplub P, and Viriyasom S (2000). Stability of extemporaneous norfloxacin suspension. Drug Dev Ind Pharm 26: 777-779.
BP (2009). British pharmacopeia: The pharmaceutical press, Her Majesty’s Stationery Office, London, vol. I and II.
Cardenas RHL, Cortes AAR, Argotte RR, Luna MP, and Dominguez RA (1994). Investigation of dissolution profiles from suspensions containing benzoyl metronidazole using a statistical model with repeated measurements. Drug Dev Ind Pharm 20: 1063-1073.
Chiu CW, and Solarek D (2009). Starch Modification. In starch: Chemistry and Technology (BeMiller J and Whistler R eds), 3rd ed., Academic Press, USA, pp 629-648.
Deicke A, and Suverkrup R (1999). Dose uniformity and redispersibility of pharmaceutical suspensions I: quantifcation and mechanical modelling of human shaking behavior. Eur J Pharm Biopharm 48: 225-232.
Deicke A, and Suverkrup R (2000). Dose uniformity and redispersibility of pharmaceutical suspensions II: assessment of three commercial erythromycin ethyl succinate oral liquids. Eur J Pharm Biopharm 49: 73-78.
Felmeister A, Kuchtyak GM, Koziol S, and Felmeister CJ (1973). Polymer-induced flocculation of pharmaceutical suspensions. J Pharm Sci 62: 2026-2027.
Femi-Oyewo MN, Adedokun, MO, and Olusoga TO (2004). Evaluation of the suspending properties of Albizia zygia gum on sulphadimidine suspension. Trop J Pharm Res 3: 279-284.
Gaikar NV, Sandhya P, and Chaudhari CA (2011). Evaluation of Curculigo orchioides mucilage as suspending Agent. Int J Pharm Tech Res 3: 831-835.
Gebre–Mariam T, and Schmidt PC (1996). Isolation and physicochemical properties of Enset starch. Starch/Starke 48: 208-214.
Gebre-Mariam T, and Schmidt PC (1998). Some physicochemical properties of dioscorea starch from Ethiopia. Starch/Stärke 50: 241-246.
ICH, Q1A (R2) (2003). Stability testing of new drug substances and products; International conference on harmonization, IFPMA, Geneva, Switzerland.
Jie Y, Wen-ren C, Manurung RM, Ganzeveld KJ, and Heeres HJ (2004). Exploratory studies on the carboxymethylation of cassava starch in water-miscible organic media. Starch/Stärke 56: 100-107.
Khalil MI, and Aly AA (2001). Preparation and evaluation of some cationic starch derivatives as flocculants. Starch/Stärke 53: 84-89.
Khalil MI, and Aly AA (2002). Preparation and evaluation of some anionic starch derivatives as flocculants. Starch/Stärke 54: 132-139.
Kittipongpatana OS, and Sirithunyalug J (2006). Development of suspending agent from sodium carboxymethyl mungbean starches. Drug Dev Ind Pharm 32: 809-820.
Kittipongpatana OS, Burapadaja S, and Kittipongpatana N (2009). Carboxymethyl mungbean starch as a new pharmaceutical gelling agent for topical preparation. Drug Dev Ind Pharm 35: 34-42.
Kittipongpatana OS, Sirithunyalug J, and Laenger R (2006). Preparation and physicochemical properties of sodium carboxymethyl mungbean starches. Carbohydr Polym 63: 105-112.
Kumar R, Patil MB, Patil SR, and Paschapur MS (2009). Evaluation of Abelmoschus esculentus mucilage as suspending agent in paracetamol suspension. Int J PharmTech Res 1: 658-665.
Lawal OS, Lechner MD, and Kulicke WM (2008). The synthesis conditions, characterizations and thermal degradation studies of an etherified starch from an unconventional source. Polym Degrad Stab 93: 1520-1528.
Lawal OS, Lechner MD, Hartmann B, and Kulicke W (2007). Carboxymethyl cocoyam starch: synthesis, characterisation and influence of reaction parameters. Starch/Stärke 59: 224-233.
Lemieux M, Gosselin P, and Mateescu MA (2009). Carboxymethyl high amylose starch as excipient for controlled drug release: mechanistic study and the influence of degree of substitution. Int J Pharm 382: 172-182.
Li X, Gao W, Huang L, Wang Y, Huang L, and Liu C (2010). Preparation and physicochemical properties of carboxymethyl Fritillaria ussuriensis Maxim. Starches. Carbohydr Polym 80: 768-773.
Madu SJ, Muazu J, and Mohammed GT (2011). The role of acid treated sweet potato starch (microcrystalline starch) on disintegrant property of paracetamol tablet formulation. Int J Pharm Res Innov 4: 32-39.
Mohammed K, Endale A, and Gebre-Mariam T (2007). Isolation, acetylation and physicochemical characterization of kottee harree (dioscorea bulbifera) starch, MSc Thesis, School of Pharmacy, Addis Ababa University.
Mulugeta T, Willemien, Lommen JM, and Struik PC (2007). Indigenous multiplication and production practices for the tuber crop P. edulis in Chencha and Wolaita, Southern Ethiopia. Exp Agr 43: 381–400.
Nabais T, Brouillet F, Kyriacos S, Mroueh M, Amores da Silva P, Bataille B, Chebli C, and Cartilier L (2007). High-amylose carboxymethyl starch matrices for oral sustained drug-release: In vitro and in vivo evaluation. Eur J Pharm Biopharm 65: 371–378.
Nattapulwat N, Purkkao N, and Suwithayapan O (2009). Preparation and application of carboxymethyl yam (Dioscorea esculenta) starch. AAPS Pharm Sci Tech 10: 193-198.
Nep EI, and Conway BR (2011). Evaluation of Grewia polysaccharide gum as a suspending agent. Int J Pharm Pharm Sci 3: 168-173.
Nigussie T, Endale A, and Gebre-Mariam T (2006). Isolation, characterization and evaluation of binding and disintegrant effects of anchote starch in paracetamol tablet formulation, MSc Thesis, School of Pharmacy, Addis Ababa University.
Nwokocha LM, and Ogunmola GB (2008). Carboxymethylation of cassava starch in different solvents and solvent-water mixtures: Optimization of reaction conditions. J Applied Sci 8: 1581-1585.
Onofre FO, and Wang YJ (2009). Hydroxy propylated starches of varying amylose contents as sustained release matrices in tablets. Int J Pharm 385: 104-112.
Onofre FO, Mendez-Montealvo G, and Wang Y (2010). Sustained release properties of cross-linked corn starches with varying amylose contents in monolithic tablets. Starch/Stärke 62: 165-172.
Paulos G, Endale A, Bultosa G, and Gebre-Mariam T (2009). Isolation and physicochemical characterization of cassava starches obtained from different regions of Ethiopia. Ethiop Pharm J 27: 42-54.
Pohja S, Suihko E, Vidgren M, Paronen P, and Ketolainen J (2004). Starch acetate as a tablet matrix for sustained drug release. J Control Rel 94: 293-302.
Rishabha M, Pranati S, Upendra K, Bhargava CS, and Kumar SP (2010). Formulation and comparison of suspending properties of different natural polymers using paracetamol suspension. Int J Drug Dev & Res 2: 886-891.
Saeedi M, Dallalpoor-Mohammadi N, and Farid D (2003). Prevention of crystal growth in acetaminophen suspensions by the use of polyvinyl pyrrolidone and bovine serum albumin. DARU 11: 106-114.
Stojanovic´ Z, Jeremic´ K, and Jovanovic S (2000). Synthesis of carboxymethyl starch. Starch/Stärke 52: 413-419.
Suthar AM, and Patel MM (2011). Formulation and evaluation of taste masked suspension of metronidazole. Int J Applied Pharm 3: 16-19.
USP XXXII/ NF XXVII (2009) United States Pharmacopoeial Convention, volume II, Inc, Rockville, Maryland.
Vu NT, Aloumanis V, Ben MJ, Kupiec TC, Patterson EK, Radke J, BA, Erickson MA, and Schneider G (2008). Stability of metronidazole benzoate in syrspend SF one-step suspension system. Int J Pharm Compounding 12: 558-564.
Wang L, Pan S, Hu H, Miao W, and Xu X (2010). Synthesis and properties of carboxymethyl kudzu root starch. Carbohydr Polym 80: 174-179.
Wang L, Pan S, Hu H, Miao W, and Xu X (2010). Synthesis and properties of carboxymethyl kudzu root starch. Carbohydr Polym 80: 174-179.
Wang P, Wu X, Dong-hua X, Kun X, Ying T, Xi-bing D, and Wen-bo L (2009). Preparation and characterization of cationic corn starch with a high degree of substitution in dioxane–THF–water media. Carbohydr Res 344: 851-855.
Xie W, Zhang Y, and Liu Y (2011). Homogenous carboxymethylation of starch using 1-butyl-3 methylimidazolium chloride ionic liquid medium as a solvent. Carbohydr Polym 85: 792-797.
Yaacob B, Amin M, Hashim K, and Bakar B (2011). Optimization of reaction conditions for carboxymethylated sago starch. Iran Polym J 20: 195-204.
Yanli W, Wenyuan G, and Xia L (2009). Carboxymethyl Chinese yam starch: synthesis, characterization, and influence of reaction parameters. Carbohydr Res 344: 1764-1769.
Yeole NB, Sandhya P, Chaudhari PS, and Bhujbal PS (2010). Evaluation of Malva sylvestris and Pedalium murex mucilage as suspending agent. Int J PharmTech Res 2: 385-389
Yeshitila M, and Weibull J (2007). Phenotypic variation and local customary use of Ethiopian potato (P. edulis (Vatke) Agnew). Master Theses, Swedish Biodiversity Centre, Uppsala.
Zatz JL, Schnitzer L, and Sarpotdar P (1979). Flocculation of sulfamerazine suspensions by a cationic polymer. J Pharm Sci 68: 1491-1494.
Zietsman S, Kilian G, Worthington M, and Stubbs C (2007). Formulation development and stability studies of aqueous metronidazole benzoate suspensions containing various suspending agents. Drug Dev Ind Pharm 33: 191-197.
Asfaw Z, and Woldu Z (1997). Crop association of homegardens in Welayta and Gurage in Southern Ethiopia. SINET: Ethiop J Sci 20: 73-90.
Azam MG, and Haider SS (2008). Evaluation of dissolution behavior of paracetamol suspensions. Dhaka Univ J Pharm Sci 7: 53-58.
Boonme P, Phadoongsombut N, Phoomborplub P, and Viriyasom S (2000). Stability of extemporaneous norfloxacin suspension. Drug Dev Ind Pharm 26: 777-779.
BP (2009). British pharmacopeia: The pharmaceutical press, Her Majesty’s Stationery Office, London, vol. I and II.
Cardenas RHL, Cortes AAR, Argotte RR, Luna MP, and Dominguez RA (1994). Investigation of dissolution profiles from suspensions containing benzoyl metronidazole using a statistical model with repeated measurements. Drug Dev Ind Pharm 20: 1063-1073.
Chiu CW, and Solarek D (2009). Starch Modification. In starch: Chemistry and Technology (BeMiller J and Whistler R eds), 3rd ed., Academic Press, USA, pp 629-648.
Deicke A, and Suverkrup R (1999). Dose uniformity and redispersibility of pharmaceutical suspensions I: quantifcation and mechanical modelling of human shaking behavior. Eur J Pharm Biopharm 48: 225-232.
Deicke A, and Suverkrup R (2000). Dose uniformity and redispersibility of pharmaceutical suspensions II: assessment of three commercial erythromycin ethyl succinate oral liquids. Eur J Pharm Biopharm 49: 73-78.
Felmeister A, Kuchtyak GM, Koziol S, and Felmeister CJ (1973). Polymer-induced flocculation of pharmaceutical suspensions. J Pharm Sci 62: 2026-2027.
Femi-Oyewo MN, Adedokun, MO, and Olusoga TO (2004). Evaluation of the suspending properties of Albizia zygia gum on sulphadimidine suspension. Trop J Pharm Res 3: 279-284.
Gaikar NV, Sandhya P, and Chaudhari CA (2011). Evaluation of Curculigo orchioides mucilage as suspending Agent. Int J Pharm Tech Res 3: 831-835.
Gebre–Mariam T, and Schmidt PC (1996). Isolation and physicochemical properties of Enset starch. Starch/Starke 48: 208-214.
Gebre-Mariam T, and Schmidt PC (1998). Some physicochemical properties of dioscorea starch from Ethiopia. Starch/Stärke 50: 241-246.
ICH, Q1A (R2) (2003). Stability testing of new drug substances and products; International conference on harmonization, IFPMA, Geneva, Switzerland.
Jie Y, Wen-ren C, Manurung RM, Ganzeveld KJ, and Heeres HJ (2004). Exploratory studies on the carboxymethylation of cassava starch in water-miscible organic media. Starch/Stärke 56: 100-107.
Khalil MI, and Aly AA (2001). Preparation and evaluation of some cationic starch derivatives as flocculants. Starch/Stärke 53: 84-89.
Khalil MI, and Aly AA (2002). Preparation and evaluation of some anionic starch derivatives as flocculants. Starch/Stärke 54: 132-139.
Kittipongpatana OS, and Sirithunyalug J (2006). Development of suspending agent from sodium carboxymethyl mungbean starches. Drug Dev Ind Pharm 32: 809-820.
Kittipongpatana OS, Burapadaja S, and Kittipongpatana N (2009). Carboxymethyl mungbean starch as a new pharmaceutical gelling agent for topical preparation. Drug Dev Ind Pharm 35: 34-42.
Kittipongpatana OS, Sirithunyalug J, and Laenger R (2006). Preparation and physicochemical properties of sodium carboxymethyl mungbean starches. Carbohydr Polym 63: 105-112.
Kumar R, Patil MB, Patil SR, and Paschapur MS (2009). Evaluation of Abelmoschus esculentus mucilage as suspending agent in paracetamol suspension. Int J PharmTech Res 1: 658-665.
Lawal OS, Lechner MD, and Kulicke WM (2008). The synthesis conditions, characterizations and thermal degradation studies of an etherified starch from an unconventional source. Polym Degrad Stab 93: 1520-1528.
Lawal OS, Lechner MD, Hartmann B, and Kulicke W (2007). Carboxymethyl cocoyam starch: synthesis, characterisation and influence of reaction parameters. Starch/Stärke 59: 224-233.
Lemieux M, Gosselin P, and Mateescu MA (2009). Carboxymethyl high amylose starch as excipient for controlled drug release: mechanistic study and the influence of degree of substitution. Int J Pharm 382: 172-182.
Li X, Gao W, Huang L, Wang Y, Huang L, and Liu C (2010). Preparation and physicochemical properties of carboxymethyl Fritillaria ussuriensis Maxim. Starches. Carbohydr Polym 80: 768-773.
Madu SJ, Muazu J, and Mohammed GT (2011). The role of acid treated sweet potato starch (microcrystalline starch) on disintegrant property of paracetamol tablet formulation. Int J Pharm Res Innov 4: 32-39.
Mohammed K, Endale A, and Gebre-Mariam T (2007). Isolation, acetylation and physicochemical characterization of kottee harree (dioscorea bulbifera) starch, MSc Thesis, School of Pharmacy, Addis Ababa University.
Mulugeta T, Willemien, Lommen JM, and Struik PC (2007). Indigenous multiplication and production practices for the tuber crop P. edulis in Chencha and Wolaita, Southern Ethiopia. Exp Agr 43: 381–400.
Nabais T, Brouillet F, Kyriacos S, Mroueh M, Amores da Silva P, Bataille B, Chebli C, and Cartilier L (2007). High-amylose carboxymethyl starch matrices for oral sustained drug-release: In vitro and in vivo evaluation. Eur J Pharm Biopharm 65: 371–378.
Nattapulwat N, Purkkao N, and Suwithayapan O (2009). Preparation and application of carboxymethyl yam (Dioscorea esculenta) starch. AAPS Pharm Sci Tech 10: 193-198.
Nep EI, and Conway BR (2011). Evaluation of Grewia polysaccharide gum as a suspending agent. Int J Pharm Pharm Sci 3: 168-173.
Nigussie T, Endale A, and Gebre-Mariam T (2006). Isolation, characterization and evaluation of binding and disintegrant effects of anchote starch in paracetamol tablet formulation, MSc Thesis, School of Pharmacy, Addis Ababa University.
Nwokocha LM, and Ogunmola GB (2008). Carboxymethylation of cassava starch in different solvents and solvent-water mixtures: Optimization of reaction conditions. J Applied Sci 8: 1581-1585.
Onofre FO, and Wang YJ (2009). Hydroxy propylated starches of varying amylose contents as sustained release matrices in tablets. Int J Pharm 385: 104-112.
Onofre FO, Mendez-Montealvo G, and Wang Y (2010). Sustained release properties of cross-linked corn starches with varying amylose contents in monolithic tablets. Starch/Stärke 62: 165-172.
Paulos G, Endale A, Bultosa G, and Gebre-Mariam T (2009). Isolation and physicochemical characterization of cassava starches obtained from different regions of Ethiopia. Ethiop Pharm J 27: 42-54.
Pohja S, Suihko E, Vidgren M, Paronen P, and Ketolainen J (2004). Starch acetate as a tablet matrix for sustained drug release. J Control Rel 94: 293-302.
Rishabha M, Pranati S, Upendra K, Bhargava CS, and Kumar SP (2010). Formulation and comparison of suspending properties of different natural polymers using paracetamol suspension. Int J Drug Dev & Res 2: 886-891.
Saeedi M, Dallalpoor-Mohammadi N, and Farid D (2003). Prevention of crystal growth in acetaminophen suspensions by the use of polyvinyl pyrrolidone and bovine serum albumin. DARU 11: 106-114.
Stojanovic´ Z, Jeremic´ K, and Jovanovic S (2000). Synthesis of carboxymethyl starch. Starch/Stärke 52: 413-419.
Suthar AM, and Patel MM (2011). Formulation and evaluation of taste masked suspension of metronidazole. Int J Applied Pharm 3: 16-19.
USP XXXII/ NF XXVII (2009) United States Pharmacopoeial Convention, volume II, Inc, Rockville, Maryland.
Vu NT, Aloumanis V, Ben MJ, Kupiec TC, Patterson EK, Radke J, BA, Erickson MA, and Schneider G (2008). Stability of metronidazole benzoate in syrspend SF one-step suspension system. Int J Pharm Compounding 12: 558-564.
Wang L, Pan S, Hu H, Miao W, and Xu X (2010). Synthesis and properties of carboxymethyl kudzu root starch. Carbohydr Polym 80: 174-179.
Wang L, Pan S, Hu H, Miao W, and Xu X (2010). Synthesis and properties of carboxymethyl kudzu root starch. Carbohydr Polym 80: 174-179.
Wang P, Wu X, Dong-hua X, Kun X, Ying T, Xi-bing D, and Wen-bo L (2009). Preparation and characterization of cationic corn starch with a high degree of substitution in dioxane–THF–water media. Carbohydr Res 344: 851-855.
Xie W, Zhang Y, and Liu Y (2011). Homogenous carboxymethylation of starch using 1-butyl-3 methylimidazolium chloride ionic liquid medium as a solvent. Carbohydr Polym 85: 792-797.
Yaacob B, Amin M, Hashim K, and Bakar B (2011). Optimization of reaction conditions for carboxymethylated sago starch. Iran Polym J 20: 195-204.
Yanli W, Wenyuan G, and Xia L (2009). Carboxymethyl Chinese yam starch: synthesis, characterization, and influence of reaction parameters. Carbohydr Res 344: 1764-1769.
Yeole NB, Sandhya P, Chaudhari PS, and Bhujbal PS (2010). Evaluation of Malva sylvestris and Pedalium murex mucilage as suspending agent. Int J PharmTech Res 2: 385-389
Yeshitila M, and Weibull J (2007). Phenotypic variation and local customary use of Ethiopian potato (P. edulis (Vatke) Agnew). Master Theses, Swedish Biodiversity Centre, Uppsala.
Zatz JL, Schnitzer L, and Sarpotdar P (1979). Flocculation of sulfamerazine suspensions by a cationic polymer. J Pharm Sci 68: 1491-1494.
Zietsman S, Kilian G, Worthington M, and Stubbs C (2007). Formulation development and stability studies of aqueous metronidazole benzoate suspensions containing various suspending agents. Drug Dev Ind Pharm 33: 191-197.
