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ARAB JOURNAL OF BASIC AND APPLIED SCIENCES University of Bahrain 2023, VOL. 30, NO. 1, 13–25 https://doi.org/10.1080/25765299.2022.2153527 ORIGINAL ARTICLE Microcrystalline cellulose promotes superior direct compressed Boesenbergia rotunda (L.) Mansf. extract tablet properties to spray-dried rice starch and spray-dried lactose a b c Jirapornchai Suksaeree , Chaowalit Monton , Natawat Chankana and Laksana Charoenchai a b Department of Pharmaceutical Chemistry, College of Pharmacy, Rangsit University, Pathum Thani, Thailand; Drug and Herbal Product Research and Development Center, College of Pharmacy, Rangsit University, Pathum Thani, Thailand; Sun Herb Thai Chinese Manufacturing, College of Pharmacy, Rangsit University, Pathum Thani, Thailand ABSTRACT ARTICLE HISTORY Received 23 August 2022 This work aimed to select tablet diluent of Boesenbergia rotunda (L.) Mansf. extract tablet. Revised 8 November 2022 Three tablet diluents, including microcrystalline cellulose (MCC), spray-dried rice starch, and Accepted 26 November 2022 spray-dried lactose were used. MCC exhibited superior performance to the other diluents by providing the hardest tablet, the lowest friability, and the shortest disintegration time. The KEYWORDS Box-Behnken design was used to evaluate the effect of hydrophobic excipients when MCC Fumed silica; magnesium was used as diluent. The optimal formulation was composed of fumed silica 1%, magnesium stearate; optimization; stearate 1%, and talcum 2%. The tablets had suitable hardness, low friability, and short disin- tablet diluent; talcum tegration time. The marker pinocembrin could be dissolved by 82% within 4 h. Although the marker decreased after three months of stability testing, the antioxidant activity of the for- mulation remained. In conclusion, MCC was shown to be superior to the other diluents, and the optimal formulation could be used to prepare Boesenbergia rotunda (L.) Mansf. extract tablet as a food supplement. 1. Introduction Toworakul, 2021), etc. During the Covid-19 pan- demic, herbal plants were screened for anti-SARS- The size of the antioxidants market will surpass CoV-2 activity. Among them, B. rotunda extract and approximately 9,000 million USD by 2026 at a 5.3% its isolated compound panduratin A exhibited anti- compound annual growth rate over the assessment SARS-CoV-2 activity (Kanjanasirirat et al., 2020). period between 2020 and 2026 (GlobeNewswire, Recently, several fingerroot extract products have 2021). A natural antioxidant is an interesting source been launched in the market. Several products with of compounds. Boesenbergia rotunda (L.) Mansf. is various doses of B. rotunda extract have been regis- one of several natural antioxidants that have been tered. The 200 mg B. rotunda extract per tablet was marketed recently. B. rotunda or fingerroot is a plant selected in this work based on the dose of marketed that belongs to the Zingiberaceae family. It is used products that have been sold in Thailand (Thai Food as a food ingredient and herbal medicine in & Drug Administration, 2022). However, there is no Southeast Asia as well as Indo-China. It possesses regulation concerning the standard dose of B. several biological and pharmacological activities, i.e. rotunda extract used for food supplements in anti-inflammatory effect (Isa et al., 2012), antimicro- Thailand (Thai Food & Drug Administration, 2017). In bial activity (Bhamarapravati, Juthapruth, Mahachai, Thailand, numerous products of B. rotunda powder & Mahady, 2006; Jitvaropas et al., 2012), antioxidant as well as its extract are typically prepared in capsule activity (Isa et al., 2012; Jitvaropas et al., 2012), dosage form, due to it being easily operated in small aphrodisiac activity (Ongwisespaiboon & herbal factories or small to medium-sized enter- Jiraungkoorskul, 2017), cytotoxic effect (Isa et al., prises. Numerous publications have reported on the 2012), vasorelaxant effect (Adhikari et al., 2020), wound healing (Jitvaropas et al., 2012; biological and pharmacological activities of B. Ruttanapattanakul et al., 2021), treatment of func- rotunda extract. However, there are limited numbers tional dyspepsia (Chitapanarux, Lertprasertsuke, & of publications based on the formulation CONTACT Chaowalit Monton chaowalit@rsu.ac.th Drug and Herbal Product Research and Development Center, College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand. Supplemental data for this article can be accessed online at https://doi.org/10.1080/25765299.2022.2153527 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group on behalf of the University of Bahrain. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 14 J. SUKSAEREE ET AL. development of B. rotunda powder or its extract. An an important step to obtain the desired direct com- innovative product incorporating B. rotunda extract pressed tablet properties. Hydrophobic excipients (e.g. fumed silica, magne- with a hydrogel wound dressing has also been sium stearate, and talcum) are also included in tablet reported (Eakwaropas et al., 2019). formulations to promote desired tablet properties. Recently, tablets have become the most popular Lubricants are used to prevent the sticking of the form of solid oral dosage. Direct compression is the tablet to the punch faces as well as to reduce fric- first choice for the preparation of tablets. Direct tion between the tablets and the die wall during the compression exhibits several advantages compared compression and ejection steps. Magnesium stearate to wet granulation or dry granulation methods, such is the most common lubricant used in tablet formu- as saving equipment, energy, space, and time. It also lation. Other lubricants such as stearic acid and cal- reduces the risk of cross-contamination due to fewer cium stearate are rarely used. Glidants are used to operating procedures, reducing the risk of microbial improve the flowability of the powder blend. Several growth and the risk of degradation of moisture as compounds can be used as glidants such as fumed well as thermal-sensitive drugs due to no water silica, starch, and talcum. Anti-adherents prevent the being used. Generally, tablets prepared by direct tablet from sticking to the die wall and punch faces. compression exhibit a faster dissolution rate. Talcum, starch, and magnesium stearate can be used However, it requires desired pharmaceutical excipi- as anti-adherents in tablet formulation (Chowhan, ent properties such as good flowability, compressibil- 2020). However, using excessive hydrophobic exci- ity, and compactability (Mura, Valleri, Baldanzi, & pients retarded drug dissolution from a solid dosage Mennini, 2019). form (Rowe et al., 2009). Thus, optimization of hydro- The direct compression diluents included in this phobic excipients is important to obtain suitable tab- work were microcrystalline cellulose (MCC), spray- let properties. dried rice starch (SRS), and spray-dried lactose (SLT). This work aimed to select a tablet diluent of dir- MCC is one of the most popular cellulose derivatives ect compressed B. rotunda extract tablet. Three tab- used as tablet diluent. It exhibits good compressibil- let diluents including MCC, SRS, and SLT were ity, so it is usually included in directly compressed included in the simplex lattice design. The most suit- tablet formulations (Zhao, Zhao, Lin, & Shen, 2022). able diluent will be used to prepare B. rotunda It also exhibits disintegration properties (Rowe, extract tablets by varying hydrophobic excipients Sheskey, & Quinn, 2009). However, it also displays including, fumed silica, magnesium stearate, and tal- poor flow properties (Jivraj, Martini, & Thomson, cum using the Box-Behnken design. Furthermore, 2000). Its angle of repose, bulk density, and tapped the stability of B. rotunda extract tablets was also 3 3 density was 28–29 , 0.34 g/cm . and 0.48 g/cm , evaluated. The authors expected that the optimal B. respectively (Rowe et al., 2009). SRS is one of the dir- rotunda extract tablet formulation could be used to ect compression fillers. It is an insoluble, neutral, and prepare antioxidant food supplement products. free-flowing powder (Vongsurakrai & Varavinit, 2010). It also exhibits disintegration properties with a poor 2. Materials and methods flow similar to MCC (Jivraj et al., 2000). Its angle of repose, bulk density, and compressibility were 2.1. Materials 35–52 , 0.37–0.45 g/cm , and 20–36%, respectively Standard pinocembrin was purchased from Chengdu (Bergthaller, Varavinit, & Wongsagonsup, 2005). Biopurify Phytochemicals Ltd., Sichuan, China. Developed SRS (Era-TabV) had excellent flowability Fingerroot extract (yellow powder; moisture content comparable to dibasic calcium phosphate but super- 3 of 3.1%; bulk density of 0.45 g/cm ; flavonoids con- ior to MCC, lactose, and pregelatinized starch. tent of 267.2 mg%) was purchased from Specialty However, MCC was superior to other diluents in Natural Product Co., Ltd., Chonburi, Thailand. MCC terms of dilution potential or carrying capacity (Comprecel M102) was purchased from Maxway (Mitrevej, Sinchaipanid, & Faroongsarng, 1996). SLT is Co., Ltd., Bangkok, Thailand. SRS (Era-Tab ) was pur- usually used as a tablet binder, filler-binder, and flow chased from Erawan Pharmaceutical Research and aid in direct compression tableting. It is a free-flow- Laboratory Co., Ltd., Bangkok, Thailand. SLT ing powder that disintegrates by dissolution. (FlowLacV) was purchased from Molkerei Meggle However, it requires high compressional force to Wasserburg GmbH & Co., Wasserburg am Inn, produce hard tablets when compared with MCC Germany. Magnesium stearate was purchased from (Jivraj et al., 2000). Its angle of repose, bulk density, Changzhou Kaide Imp. & Exp. Co., Ltd., Changzhou, and tapped density were 28–29 , 0.57–0.67 g/cm , China. Talcum was purchased from Nitika and 0.67–0.78 g/cm , respectively (Rowe et al., 2009). Pharmaceutical Specialities Pvt. Ltd., Nagpur, India. The selection of direct compression diluents may be Fumed silica was purchased from P.C. Drug Center, ARAB JOURNAL OF BASIC AND APPLIED SCIENCES 15 Bangkok, Thailand. Sodium lauryl sulphate (SLS) was step. The optimal formulation was prepared again to purchased from EMD Millipore Corporation, obtain the experimental values. The experimental Massachusetts, USA. 2,2-diphenyl-1-picrylhydrazyl values were compared with the predicted values and (DPPH) was purchased from Sigma-Aldrich Pte Ltd., the percentage error was calculated as Eq. (1). Ascent, Singapore. Acetonitrile (HPLC grade) was ðExperimental value Predicted valueÞ purchased from Fisher Chemical, Leicestershire, UK. ðÞ Error % ¼ Experimental value 2.2. Simplex lattice design for the selection of (1) tablet diluent A simplex lattice design was applied for the selection of tablet diluent. The ratios of three diluents 2.3. Box-Behnken design for optimization of the including MCC, SRS, and SLT were varied for 14 for- tablet formulation mulations, comprising 9 individual formulations and The Box-Behnken design was applied for optimiza- 5 replicated formulations. The replicated formula- tion of the suitable content of hydrophobic exci- tions were prepared to check the variation of the pients when the most suitable diluent was used. design, as shown in Table 1. Three hydrophobic excipients including fumed silica, The tablet formulations were composed of magnesium stearate, and talcum were varied for 17 33.33% B. rotunda extract powder (or 200 mg per formulations, 12 individual formulations and 5 repli- tablet), 1% fumed silica, 1% magnesium stearate, 2% cated formulations, as shown in Table 2. talcum, and 62.67% diluents. The total tablet weight The tablet formulations were composed of was 600 mg. A total of 35 tablets were prepared for 33.33% B. rotunda extract powder (or 200 mg per each formulation. B. rotunda extract powder was tablet), 0.5–1.5% fumed silica, 0.5–1.5% magnesium mixed with half the content of diluents for 5 min. stearate, 2–4% talcum, and 62.67% suitable diluent Premix was prepared by mixing fumed silica, magne- obtained from the simplex lattice design. The total sium stearate, and talcum, with diluents. tablet weight was 600 mg. A total of 35 tablets were Subsequently, the premix was blended with the mix- prepared for each formulation. The mixing, tableting, ture of B. rotunda extract powder and diluents for and evaluating steps were done according to the 3 min. The obtained mixture was individually simplex lattice design section. weighed for 600 mg, followed by compressing the Response surfaces were produced using Design- tablet using 1,000 psi using a hydraulic press con- ExpertV software. Analysis of variance data were nected to a pressure gauge. The tablet properties reported. The design spaces were produced. The cri- were evaluated, including weight and weight vari- teria of the design spaces were hardness of 5–7 kP, ation, diameter, thickness, hardness, friability, and friability of less than 1%, and disintegration time of disintegration time. Contour plots were produced using Design- less than 1 min. Optimization was done using the V software – the formulation with minimized friability Expert software (v. 11) (Stat-Ease Inc., Minnesota, and within the design space was selected for the USA). Analysis of variance data were reported. Optimization was done using the software – the for- confirmation step. The optimal formulation was pre- pared again to obtain the experimental values. The mulation with minimized friability and minimized disintegration time was selected for the confirmation experimental values were compared with the Table 1. Factors and responses for the simplex lattice design. Factors Responses Formulations MCC SRS SLT Weight (mg) Diameter (mm) Thickness (mm) Hardness (kP) Friability (%) Disintegration time (min) 1 1 0 0 603.89 ± 1.85 12.82 ± 0.02 4.31 ± 0.06 7.62 ± 0.39 0.27 0.56 ± 0.01 2 0 1 0 600.22 ± 2.64 12.90 ± 0.03 4.42 ± 0.07 2.06 ± 0.20 100.00 6.48 ± 0.05 3 0 0 1 601.78 ± 1.57 12.80 ± 0.02 4.10 ± 0.03 1.28 ± 0.10 100.00 6.71 ± 0.18 4 0.5 0.5 0 604.11 ± 1.34 12.85 ± 0.02 4.25 ± 0.04 4.63 ± 0.20 0.79 1.42 ± 0.09 5 0.5 0 0.5 605.01 ± 1.42 12.81 ± 0.01 4.17 ± 0.02 2.60 ± 0.14 3.03 0.49 ± 0.01 6 0 0.5 0.5 599.98 ± 2.75 12.84 ± 0.02 4.19 ± 0.03 1.77 ± 0.08 100.00 3.39 ± 0.07 7 0.67 0.17 0.17 603.49 ± 1.65 12.84 ± 0.02 4.28 ± 0.03 4.09 ± 0.12 1.69 0.46 ± 0.01 8 0.17 0.67 0.17 601.41 ± 1.69 12.87 ± 0.02 4.32 ± 0.03 1.96 ± 0.17 100.00 4.92 ± 0.04 9 0.17 0.17 0.67 603.33 ± 1.60 12.84 ± 0.02 4.19 ± 0.02 1.66 ± 0.06 100.00 1.55 ± 0.04 10 0.33 0.33 0.33 600.97 ± 2.33 12.86 ± 0.03 4.30 ± 0.03 1.93 ± 0.09 100.00 1.01 ± 0.04 11 0.33 0.33 0.33 600.93 ± 2.30 12.83 ± 0.01 4.25 ± 0.04 2.31 ± 0.12 100.00 1.27 ± 0.01 12 0.33 0.33 0.33 601.97 ± 1.29 12.85 ± 0.01 4.29 ± 0.04 2.03 ± 0.13 100.00 1.10 ± 0.06 13 0.33 0.33 0.33 601.97 ± 1.80 12.87 ± 0.02 4.32 ± 0.04 2.12 ± 0.12 100.00 1.14 ± 0.05 14 0.33 0.33 0.33 601.68 ± 1.76 12.85 ± 0.02 4.31 ± 0.02 2.23 ± 0.08 100.00 1.20 ± 0.06 MCC ¼ microcrystalline cellulose, SRS ¼ spray-dried rice starch, SLT ¼ spray-dried lactose. 16 J. SUKSAEREE ET AL. Table 2. Factors and responses for the Box-Behnken design. Factors Responses Fumed Magnesium Diameter Thickness Formulations silica (%) stearate (%) Talcum (%) Weight (mg) (mm) (mm) Hardness (kP) Friability (%) Disintegration time (min) 1 0.5 0.5 3 604.25 ± 1.22 12.76 ± 0.03 4.26 ± 0.04 7.78 ± 0.24 0.32 0.44 ± 0.08 2 1.5 0.5 3 604.88 ± 1.63 12.76 ± 0.03 4.35 ± 0.04 5.83 ± 0.20 1.04 0.30 ± 0.02 3 0.5 1.5 3 604.57 ± 1.45 12.76 ± 0.03 4.26 ± 0.03 5.95 ± 0.28 0.87 0.35 ± 0.03 4 1.5 1.5 3 604.02 ± 1.10 12.77 ± 0.03 4.30 ± 0.05 6.10 ± 0.25 0.84 0.39 ± 0.02 5 0.5 1 2 604.68 ± 0.95 12.79 ± 0.02 4.31 ± 0.03 6.82 ± 0.22 0.33 0.48 ± 0.01 6 1.5 1 2 603.92 ± 1.29 12.78 ± 0.03 4.36 ± 0.03 6.52 ± 0.12 0.46 0.36 ± 0.03 7 0.5 1 4 604.63 ± 1.11 12.79 ± 0.04 4.28 ± 0.05 6.73 ± 0.25 0.38 0.40 ± 0.04 8 1.5 1 4 604.32 ± 1.14 12.77 ± 0.05 4.33 ± 0.06 6.40 ± 0.27 0.53 0.40 ± 0.04 9 1 0.5 2 606.59 ± 1.94 12.77 ± 0.03 4.38 ± 0.04 6.95 ± 0.19 0.27 0.30 ± 0.02 10 1 1.5 2 605.16 ± 0.96 12.75 ± 0.04 4.37 ± 0.07 6.20 ± 0.36 0.89 0.37 ± 0.03 11 1 0.5 4 605.64 ± 1.50 12.79 ± 0.03 4.39 ± 0.05 5.97 ± 0.29 0.80 0.37 ± 0.02 12 1 1.5 4 606.45 ± 0.91 12.78 ± 0.03 4.25 ± 0.04 6.36 ± 0.22 0.32 0.61 ± 0.03 13 1 1 3 604.24 ± 1.50 12.78 ± 0.03 4.28 ± 0.06 6.49 ± 0.33 0.43 0.51 ± 0.11 14 1 1 3 604.69 ± 2.73 12.78 ± 0.03 4.28 ± 0.05 7.42 ± 0.29 0.57 0.52 ± 0.10 15 1 1 3 604.03 ± 1.24 12.78 ± 0.03 4.25 ± 0.04 6.76 ± 0.35 0.49 0.60 ± 0.07 16 1 1 3 603.75 ± 2.50 12.79 ± 0.02 4.29 ± 0.05 6.01 ± 0.41 0.44 0.48 ± 0.12 17 1 1 3 605.53 ± 1.59 12.78 ± 0.03 4.30 ± 0.06 7.46 ± 0.68 0.44 0.66 ± 0.19 predicted values and the percentage error was calcu- dedusted and weighed (W ) again. Friability was cal- culated using Eq. (3). lated as Eq. (1). W W 1 2 ðÞ Friability % ¼ 100 (3) 2.4. Evaluation of tablet properties 2.4.1. Weight and weight variation 2.4.5. Disintegration time Twenty tablets were individually weighed using an Six tablets were evaluated for disintegration in water analytical balance (Entris224i-1S, Sartorius AG, using a disintegration tester (K.S.L. Engineering Co. Gottingen, Germany). The average value and SD Ltd., Bangkok, Thailand). The medium was controlled were reported. Weight variation was calculated as at 37 C ± 0.5 C. The average value and SD Eq. (2). were reported. ðÞ Weight variation % Individual weight Average weight ¼ 100 2.5. Dissolution test Average weight Three optimal tablets were tested for pinocembrin (2) dissolution from the fingerroot extract tablets by means of a modified beaker method using a 250-mL 2.4.2. Diameter and thickness beaker. The 0.5% SLS solution (100 mL) was used as Twenty tablets were tested using a thickness gauge. a dissolution medium. The temperature was con- The average value and SD were reported. trolled at 37 C ± 0.5 C. Tablets were shaken at 100 rpm. The medium was sampled for 3 mL at 2.4.3. Hardness 15 min, 30 min, 60 min, 120 min, 180 min, and Ten tablets were tested by a digital hardness tester 240 min. The fresh medium was replenished to main- (TBH 220 TD, Erweka GmbH, Heusenstamm, Germany). tain the volume of the dissolution medium. The The average value and SD were reported. withdrawn medium was filtered and analyzed by HPLC to produce the dissolution profile of pinocem- 2.4.4. Friability brin from the tablets. The United States Pharmacopeia (USP) specifies that a sample of whole tablets corresponding as near as 2.6. HPLC condition for determination of possible to 6.5 g should be used for the friability test pinocembrin content (USP 41/NF 36, 36, 2018). According to this work, a unit weight of 600 mg was prepared, resulting in Pinocembrin contained in the optimal tablet and eleven tablets being sampled for the friability test. pinocembrin dissolved from the optimal tablet were Eleven tablets were dedusted and weighed (W ) analyzed by Agilent 1260 Infinity (Agilent using an analytical balance. Friability was tested Technologies, California, USA). The analytical column using a friability tester (K.S.L. Engineering Co. Ltd., was ACE C18-PFP (250 4.6 mm, i.d., 5 mm). It was Bangkok, Thailand). The drum of the friability tester controlled at 25 C. The mobile phase was composed was rotated at the rate of 25 rpm for 4 min (a total of water (A) and acetonitrile (B). At 0 to 15 min, B of 100 rounds). Subsequently, the tablets were was increased from 50% to 100%; at 15 to 16 min, B ARAB JOURNAL OF BASIC AND APPLIED SCIENCES 17 was decreased from 100% to 50% and maintained 3. Results and discussion for 2 min. The flow rate of the mobile phase was 3.1. Optimal tablet diluent of B. rotunda 1 mL/min. The injection volume was 10 mL. The extract tablet detection wavelength for pinocembrin was 288 nm. The simplex lattice design is a mixture design that The HPLC chromatograms, method validation, and varies the ratios for the components of interest system suitability data are shown in the (Duangjit & Kraisit, 2018). Thus, a simplex lattice Supplementary Material section. design was applied in the selection of tablet diluents by varying the ratios of three direct compression 2.7. DPPH radical scavenging assay diluents. Responses to the simplex lattice design are shown in Table 1. The total weight of each tablet Three optimal tablets were pulverized using a glass was close to 600 mg, due to it being individually mortar and pestle and then accurately weighed to weighed during the research and development step. 600 mg, followed by delivery to a 25-mL volumetric Consequently, the weight variation was acceptable – flask and adjustment to the volume by methanol. no tablet had a weight variation exceeding 5%. The The mixture was sonicated for 5 min and then fil- diameter of the tablets was between 12.8 and tered using a 0.45-mm syringe filter. The filtrate was 12.9 mm. Four responses including thickness, hard- used to determine DPPH radical scavenging activity. ness, friability, and disintegration time were further The reaction was done on a 96-well plate. Briefly, analyzed by Design-ExpertV software to produce the 100 mL of samples (n ¼ 3) were mixed with 100 mLof contour plots. Contour plots of thickness, hardness, 80 mM DPPH in methanol. A blank sample was a mix- friability, and disintegration time of B. rotunda ture of 100 mL of methanol mixed with 100 mLof extract tablet obtained from the simplex lattice 80 mM DPPH methanolic solution. They were mixed design are shown in Figure 1. Using SRS and SLT well and kept in the dark at room temperature for provided the thickest and thinnest tablets, respect- 30 min. Absorbance was measured using a micro- ively (Figure 1a). This occurrence could be described plate reader (Biorad Laboratories, Inc., California, by the highest density of SLT compared with SRS USA) at 517 nm (Monton et al., 2022). Percentage and MCC (Rowe et al., 2009). MCC provided medium DPPH radical scavenging was calculated as Eq. (4). thickness though it also showed the hardest tablet compared with SRS and SLT (Figure 1b). This phe- ðÞ DPPH radical scavenging % nomenon reinforced that MCC is the most popular Absorbance Absorbance blank sample cellulose derivative used as a tablet diluent because ¼ 100 Absorbance blank of its advantageous compressibility (Rowe et al., (4) 2009). When SRS was used, tablet hardness was slightly higher than that of SLT. The low hardness of tablets containing SRS and SLT provided friable tab- lets (Figure 1c). Among them, tablets containing 2.8. Stability test MCC exhibited the shortest disintegration time The optimal tablet formulations were packed in a (Figure 1d) because they displayed disintegrant polyethylene terephthalate (PET) bottle with desic- properties (Rowe et al., 2009). The contour plots of cants and sealed with a pressure-sensitive cap seal the four responses showed that MCC was the most foam liner before being capped with an aluminium- suitable direct compression diluent of the B. rotunda coated plastic cap. They were stored in a climate extract tablet. chamber (Memmert GmbH þ Co. KG, Schwabach, Although MCC showed excellent compactibility at Germany) at 30 C± 2 C/75%RH ± 5%RH and low pressure (Jivraj et al., 2000), it revealed poor 45 C± 2 C/75%RH ± 5%RH for three months. They flow properties (Jivraj et al., 2000). According to the have tested tablet properties (including, weight and mechanism of MCC, the high porosity of MCC weight variation, thickness, diameter, hardness, fri- encourages the swelling and disintegration of tab- ability, and disintegration time), pinocembrin con- lets, which is due to either water entering the hydro- tent, and DPPH radical scavenging activity, philic tablet matrix by capillary action of the pores compared with an initial time point. The statistical or a breaking down of the hydrogen bonds. differences between the three groups were analyzed Furthermore, MCC demonstrated a rapid water- through One-way analysis of variance (One-way wicking rate with minimal elastic deformation in its ANOVA) using SPSS Statistics 22.0 (IBM, New York, nature. The ability for tablet disintegration is pro- USA) followed by the Tukey HSD post-hoc analysis. vided by these characteristics (Chaerunisaa, Data were significantly different when the P-value Sriwidodo, & Abdassah, 2019). Various lactoses are was less than 0.05 at a 95% confidence interval. free-flowing powders that disintegrate by 18 J. SUKSAEREE ET AL. Figure 1. Contour plots of (a) thickness, (b) hardness, (c) friability, and (d) disintegration time of Boesenbergia rotunda (L.) Mansf. extract tablet obtained from the simplex lattice design. dissolution. In the case of SLT, it requires high com- increased tablet thickness. The interaction between pressional force to produce hard tablets. two factors – X X ,X X , and X X , decreased tablet 1 2 1 3 2 3 Furthermore, a disintegrant is necessary for SLT- thickness. Only X X and X X exhibited significant 1 2 2 3 based tablets (Jivraj et al., 2000). A diluent SRS also effects. The linear terms of MCC (X ), SRS (X ), and 1 2 exhibited disintegration properties with a poor flow SLT (X ), increased tablet hardness, respectively. The similar to MCC (Jivraj et al., 2000). Previously, it was X X X and X X significantly decreased tablet hard- 1 2 3 1 3 reported that SRS with the trade name of Era-TabV ness. The other terms did not significantly affect tab- used in this work had superior flowability compared let hardness. However, X X X and X X seemed to 1 2 3 2 3 with MCC, lactose, dibasic calcium phosphate, and increase while X X and X X X seemed to decrease 1 2 1 2 3 pregelatinized starch. However, MCC was superior to tablet hardness. According to friability, MCC (X ) sig- other diluents in terms of dilution potential or carry- nificantly decreased friability while SRS (X ) and SLT ing capacity (Mitrevej et al., 1996). One publication (X ) significantly increased friability. The terms 2 2 X X X and X X X significantly increased friability, suggested that starch is an alternative to MCC and 1 2 3 1 2 3 lactose (Jivraj et al., 2000). while the other terms decreased friability; among Analysis of variance for the simplex lattice design them, only X X and X X were significant factors. In 1 2 1 3 is shown in Table 3. According to tablet thickness, the case of disintegration time, MCC (X ), SRS (X ), 1 2 SRS (X ), MCC (X ), and SLT (X ) significantly and SLT (X ) significantly increased disintegration 2 1 3 3 increased tablet thickness, respectively, due to pro- time. SRS (X ) and SLT (X ) had higher increased dis- 2 3 viding the highest coefficient values. The interaction integration time than MCC (X ). The terms X X X 1 1 2 3 among the three factors (X X X ) also significantly and X X X increased disintegration time, but only 1 2 3 1 2 3 ARAB JOURNAL OF BASIC AND APPLIED SCIENCES 19 Table 3. Analysis of variance for the simplex lattice design. Thickness Hardness Friability Disintegration time Polynomial terms Coefficient P-value Coefficient P-value Coefficient P-value Coefficient P-value Model – <0.0001 – <0.0001 – <0.0001 – <0.0001 Linear Mixture – <0.0001 – <0.0001 – <0.0001 – <0.0001 X -MCC 4.31 – 7.61 – 0.46 – 0.61 – X -SRS 4.42 – 2.05 – 99.27 – 6.53 – X -SLT 4.10 – 1.27 – 99.27 – 6.76 – X X 0.46 0.0024 0.89 0.2789 200.38 0.0001 8.19 0.0021 1 2 X X 0.14 0.2078 7.45 0.0002 191.42 0.0002 12.37 0.0003 1 3 X X 0.28 0.0261 0.35 0.6502 3.00 0.8823 12.61 0.0003 2 3 X X X 3.10 0.0005 –––––– 1 2 3 X X X –– 38.32 0.0505 290.17 0.4950 9.18 0.7624 1 2 3 X X X –– 41.27 0.0398 3,282.44 0.0004 175.70 0.0017 1 2 3 X X X –– 26.74 0.1337 3,202.19 0.0005 161.32 0.0025 1 2 3 Lack of Fit – 0.9992 – 0.4093 ––– 0.0034 Significant values. MCC ¼ microcrystalline cellulose, SRS ¼ spray-dried rice starch, SLT ¼ spray-dried lactose. were further analyzed by Design-ExpertV software to Table 4. Confirmation of the prediction by computer soft- produce the response surfaces. Response surfaces of ware according to the simplex lattice design and Box- Behnken design. thickness, hardness, friability, and disintegration time Predicted Experimental of B. rotunda extract tablet obtained from the Box- Responses values values Error (%) Behnken design are shown in Figure 2. Figure 2a Simplex lattice design shows that increasing fumed silica increased tablet Thickness (mm) 4.31 4.26 ± 0.02 1.17 Hardness (kP) 7.61 7.50 ± 0.27 1.47 thickness. Increasing magnesium stearate slightly Friability (%) 0.00 0.04 100.00 increased tablet thickness at low talcum levels, while Disintegration time (min) 0.61 0.58 ± 0.01 5.17 decreasing tablet thickness at medium and high tal- Box-Behnken design Thickness (mm) 4.35 4.38 ± 0.02 0.68 cum levels. Figure 2b shows that maximum hardness Hardness (kP) 6.83 7.28 ± 0.23 6.18 was found at a low level of fumed silica and magne- Friability (%) 0.34 0.37 8.10 Disintegration time (min) 0.47 0.47 ± 0.07 0.00 sium stearate for all talcum levels. Figure 2c shows that increasing fumed silica increased tablet friability. Increasing magnesium stearate increased friability at X X X showed a significant effect. The other terms 1 2 3 low talcum levels while decreasing friability at high significantly decreased disintegration time. talcum levels. Figure 2d shows that the longest dis- The formulation with minimized friability and mini- integration time was found for the medium fumed mized disintegration time was selected for the con- silica and medium magnesium stearate. firmation step. Thus, MCC was selected as a direct It is well known that the action of fumed silica to compression diluent. A low percent error was enhance the flow characteristics of pharmaceutical observed for tablet thickness, hardness, and disinte- powders is based on the disruption of inter-particle gration time. These data indicated that the prediction R forces as well as reduced friction force by silica par- by Design-ExpertV software was accurate. A high per- ticles adhering to the particle surface (Paul & Sun, centage error was found for friability. This occurrence 2018; Tran et al., 2019). Fumed silica is a light and could be observed when the predicted value was 0; loose material with a very low density of the percentage error was always 100% for any experi- 0.029–0.042 g/cm (Rowe et al., 2009). Thus, increas- mental value. However, the tablet friability was lower ing fumed silica in the tablet formula made tablets than 1%, so it was acceptable (Table 4). thicker, lowered hardness, raised friability, and short- ened disintegration time. In the present work, mag- 3.2. Optimal hydrophobic excipients of B. nesium stearate varied slightly in a range from 0.5 to rotunda extract tablet 1.5%, which marginally affected the physical proper- ties of tablets. This effect could be found in previous The Box-Behnken design was applied for optimiza- work, hardness and disintegration time of tablets tion of the suitable content of hydrophobic exci- containing spray-dried optimized Lippia origanoides pients when MCC was used as a direct compression extract seemed to not be affected by magnesium diluent. Three hydrophobic excipients including stearate content when varied from 0.5% to 1.0% fumed silica, magnesium stearate, and talcum were (Coelho et al., 2018). However, magnesium stearate varied. Responses to the Box-Behnken design are could reduce compactibility, prolong disintegration shown in Table 2. The total weight of each tablet was close to 600 mg. Moreover, the weight variation time, and delay the drug release of chlorpheniramine was acceptable. The diameter of the tablets was maleate and prednisolone (Kuncahyo & Choiri, 2014). approximately 12.8 mm. Four responses including In many cases, adding talcum to formulations can thickness, hardness, friability, and disintegration time enhance the hardness, friability, and appearance of 20 J. SUKSAEREE ET AL. Figure 2. Response surfaces of thickness, hardness, friability, and disintegration time of Boesenbergia rotunda (L.) Mansf. extract tablet obtained from the Box-Behnken design when different talcum levels were used: (a) talcum 2%, (b) talcum 3%, and (c) talcum 4%. tablets (Li & Wu, 2014). In this work, the authors insignificantly decreased tablet hardness. In the case found that complex interactions among several fac- of tablet friability, X X ,X X , and X significantly 1 2 2 3 3 tors could be observed. decreased tablet friability. The terms X and X have 1 2 Analysis of variance for the Box-Behnken design is significantly increased tablet friability; while the shown in Table 5. In the case of tablet thickness, other terms insignificantly increased tablet friability. 2 2 2 fumed silica (X ), magnesium stearate (X ), X , and According to disintegration time, the terms X ,X , 1 2 2 1 2 2 2 X increased tablet thickness; among them, X ,X , and X insignificantly decreased disintegration time, 3 1 2 3 and X were significant terms. The other terms while the other terms insignificantly increased disin- decreased tablet thickness, talcum (X ) and X X tegration time. The statistical experimental design 3 2 3 were significant terms. According to tablet hardness, could identify linear, interaction, and quadratic terms three terms – talcum (X ), X X , and X X , insignifi- of several factors. It is hard to describe compared 3 1 2 2 3 cantly increased tablet hardness. The other terms with one factor at a time, which is done by changing ARAB JOURNAL OF BASIC AND APPLIED SCIENCES 21 Table 5. Analysis of variance for the Box-Behnken design. Thickness Hardness Friability Disintegration time Polynomial terms Coefficient P-value Coefficient P-value Coefficient P-value Coefficient P-value Model – 0.0059 – 0.3543 – 0.0008 – 0.1608 Intercept 4.57 – 9.27 – 2.23 – 0.15 – X -Fumed silica 0.17 0.0061 2.00 0.1463 0.37 0.0033 0.33 0.3848 X -Magnesium stearate 0.04 0.0119 1.65 0.2377 0.77 0.0638 0.37 0.2328 X -Talcum 0.24 0.0241 0.08 0.5109 1.29 0.7302 0.19 0.2927 X X 0.05 0.2718 2.10 0.0860 0.75 0.0021 0.18 0.3191 1 2 X X 5.24 10 1.0000 0.02 0.9780 0.01 0.9026 0.06 0.4978 1 3 X X 0.07 0.0173 0.57 0.3143 0.55 0.0002 0.09 0.3448 2 3 X 0.03 0.4866 0.33 0.7562 0.30 0.0944 0.37 0.0566 X 0.08 0.0911 1.32 0.2384 0.88 0.0007 0.36 0.0620 X 0.05 0.0023 0.13 0.6334 0.12 0.0149 0.05 0.2546 Lack of Fit – 0.3234 – 0.7959 – 0.1660 – 0.3101 Significant values. Coefficient values were based on actual equations. Figure 3. Design spaces that Boesenbergia rotunda (L.) Mansf. extract tablet had hardness of 5–7 kP, friability of less than 1%, and disintegration time of less than 1 min at different talcum levels: (a) talcum 2%, (b) talcum 3%, and (c) talcum 4%. which hardness was 5–7 kP, friability was less than 1%, and disintegration time was less than 1 min. Design spaces are shown in Figure 3. The formulation with minimized friability and within the design space was selected for the con- firmation step. Thus, a tablet formulation containing 1% fumed silica, 1% magnesium stearate, and 2% talcum was selected. A low percent error (less than 10%) was observed for all responses. These data indicated that the prediction by Design-ExpertV soft- ware was accurate (Table 4). Furthermore, the opti- mal tablet formulation was sampled for the Figure 4. The dissolution profile of pinocembrin from opti- dissolution test. The dissolution profile in 0.5% SLS mal Boesenbergia rotunda (L.) Mansf. extract tablets when 0.5% SLS was used as a dissolution medium. of pinocembrin from B. rotunda extract tablets is shown in Figure 4. It was found that pinocembrin was dissolved for 81.56 ± 7.23% within 240 min. the value of one factor before measuring the According to the dissolution test procedure, it was response and repeating the process with another confirmed from previous work that the modified factor (JMP Statistical Discovery LLC, 2022). However, method did not affect the sink condition. The apparent the response surface obtained from the Design of solubility of pinocembrin in water was 48.33 mg/mL at Experiment (DOE) approach gave more information room temperature (Yang et al., 2018). Unfortunately, about the effect of several factors simultaneously using 100 mL of water during the dissolution test could (Gibson, 2016; Steele, 2018). not provide certain sink conditions. Therefore, SLS was The optimization data showed that the formula- added to the aqueous medium at a final concentration tion with minimized friability was found when of 0.5% to increase the solubility of poorly water-sol- medium fumed silica, medium magnesium stearate, uble pinocembrin, resulting in the promotion of sink and low talcum level were used. Moreover, design spaces were constructed to select the formulation in conditions (Fotaki et al., 2013). 22 J. SUKSAEREE ET AL. Figure 5. Stability of optimal Boesenbergia rotunda (L.) Mansf. extract tablets after being stored at 30 C±2 C/75%RH ± 5%RH and 45 C±2 C/75%RH ± 5%RH for three months compared with the initial time. Statistical difference was analyzed by One-way ANOVA with post-hoc analysis using Tukey HSD: which NS ¼ not significant, ¼ P< 0.05, ¼ P< 0.01, and ¼ P< 0.001. ARAB JOURNAL OF BASIC AND APPLIED SCIENCES 23 panduratin A, etc. (Jirakiattikula, Rithichaia, Prachaia, 3.3. Stability of optimal B. rotunda extract tablet & Itharat, 2021; Tan et al., 2015), might be performed in future work. The optimal B. rotunda extract tablets had their sta- bility tested for three months at 30 C± 2 C/75%RH ± 5%RH and 45 C± 2 C/75%RH ± 5%RH. The tablet 4. Conclusion weight, thickness, diameter, hardness, friability, disin- Tablet diluents including MCC, SRS, SLT, and their tegration time, pinocembrin content, and antioxidant mixtures were optimized and selected using the sim- activity were compared with an initial time. The sta- plex lattice design. Among them, MCC alone exhib- bility data of optimal B. rotunda extract tablets are ited superior performance compared to the other shown in Figure 5. After three months, tablet weight, diluents. It provided the hardest tablet, the lowest thickness, and diameter significantly increased, while friability, and the shortest disintegration time, which tablet hardness decreased. Increasing the storage were the desired tablet properties. Consequently, temperature from 30 Cto 45 C also significantly MCC was used as a diluent for the optimization of increased all parameters, but was not significantly hydrophobic excipients by the Box-Behnken design. different for tablet hardness. The friability remained The three hydrophobic excipients were fumed silica, less than 0.5% for all storage temperatures. The fri- magnesium stearate, and talcum. The optimal formu- ability of plain tablet dosage form should be less lation promoted the desired properties (i.e. hardness than 1%, so the friability of the B. rotunda extract of 5–7 kP, friability of less than 1%, and disintegra- tablets was acceptable. The disintegration time was tion time of less than 1 min), composed of fumed sil- significantly increased and depended on storage ica 1%, magnesium stearate 1%, and talcum 2%. The temperature. However, the disintegration time was marker pinocembrin was selected as a marker for less than 30 min, indicating that it was acceptable. quality control. It could be dissolved by 82% within Pinocembrin content was significantly decreased in a 4 h of the dissolution test. Stability data showed that temperature-dependent manner. However, the anti- the marker content decreased after three months, oxidant activity of the B. rotunda extract tablet was while antioxidant activity was preserved with a sig- significantly increased. nificant increase. In summary, MCC exhibited super- The optimal B. rotunda extract tablets were stored ior performance compared to the SRS and SLT. The in a PET bottle during the stability test. Plastic bot- optimal formulation could be used to prepare B. tles are unbreakable, collapsible, and light compared rotunda extract tablets as a food supplement with to glass bottles (World Health Organization, 2002). desired properties. However, PET bottles exhibit higher oxygen perme- ability than glass bottles (Toussaint, Vidal, & Salmon, 2014). Oxygen and moisture permeation from the Acknowledgements environment to drug products could degrade the The authors would like to acknowledge Mr. Teetuch active compounds as well as their bioactivity (Blessy, Hanburiwong, Mr. Panachai Chomai, Mr. Prachpakorn Patel, Prajapati, & Agrawal, 2014). Pinocembrin is Prasertpol, and Miss Tharuetamon Thammawat for their possibly degraded under excessive heat and expos- research assistance. We also acknowledge Miss Worawan ure duration. The interaction and quadratic terms of Saingam for providing the fingerroot extract used in this temperature and time play a negative role on pino- work. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for- cembrin (Sheng, Wang, Zhao, & Yu, 2017). Moreover, profit sectors. pinocembrin is highly degraded under pH 7.6 condi- tions (Zhou et al., 2014). So, using a PET bottle could not preserve the stability of the B. rotunda extract CRediT authorship contribution statement tablets. This occurrence was related to increasing Jirapornchai Suksaeree: Methodology, Formal analysis, tablet weight; expanding the tablet promoted the Investigation, Writing – Original Draft. Chaowalit Monton: increase of tablet thickness and diameter, conse- Conceptualization, Methodology, Formal analysis, quently decreasing hardness due to loss of compact- Investigation, Resource, Writing – Original Draft, Writing – Review & Editing, Visualization, Supervision, Project admin- ibility. Furthermore, pinocembrin was also decreased. istration. Natawat Chankana: Methodology, Formal ana- However, the antioxidant activity was preserved, lysis, Investigation, Resource, Writing – Original Draft. which indicated that the bioactivity could be pro- Laksana Charoenchai: Methodology, Formal analysis, moted by several compounds contained in the B. Resource, Writing – Original Draft. rotunda extract rather than only pinocembrin. The authors mentioned that changing the container for Disclosure statement B. rotunda extract tablet from PET bottle to glass bottle or the selection of new markers such as pinos- No potential conflict of interest was reported by trobin, naringenin, alpinetin, 4-hydroxypanduratin A, the authors. 24 J. SUKSAEREE ET AL. Gibson, M. (2016). Pharmaceutical preformulation and formula- ORCID tion: A practical guide from candidate drug selection to com- Jirapornchai Suksaeree http://orcid.org/0000-0002-5223-9203 mercial dosage form. New York: Informa Healthcare. 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Arab Journal of Basic and Applied Sciences – Taylor & Francis
Published: Dec 31, 2023
Keywords: Fumed silica; magnesium stearate; optimization; tablet diluent; talcum
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