{"id":59904,"date":"2024-09-30T11:10:05","date_gmt":"2024-09-30T11:10:05","guid":{"rendered":"https:\/\/biomedpharmajournal.org\/?p=59904"},"modified":"2024-10-09T18:17:54","modified_gmt":"2024-10-09T18:17:54","slug":"formulation-and-characteristics-of-film-forming-hydrogel-ffh-of-yellow-root-extract-arcangelisia-flava-l-merr-as-wound-healing-for-burns","status":"publish","type":"post","link":"https:\/\/biomedpharmajournal.org\/staging\/vol17no3\/formulation-and-characteristics-of-film-forming-hydrogel-ffh-of-yellow-root-extract-arcangelisia-flava-l-merr-as-wound-healing-for-burns\/","title":{"rendered":"Formulation and Characteristics of Film Forming Hydrogel (FFH) of Yellow Root Extract (Arcangelisia Flava (L.) Merr.) As Wound Healing for Burns"},"content":{"rendered":"\n

Introduction<\/strong><\/p>\n\n\n\n

Burn injuries remain a global health threat.\nThe rate of injury is 92 %, and burn injury is one of them 1<\/sup>.\nIn a previous study, the prevalence of burns reached 0.6 percent 2<\/sup>. Burns\nare the tissue response of the skin to temperature-induced trauma. Several\nthings, such as heat, steam, chemicals, and electricity<\/sup>, can\ncause burns. Most burn injuries were caused by high temperatures or heat,\naccounting for 95 percent of the total incidence. The types of heat-related\ninjuries were categorized into three categories, including blisters (50\npercent), burns from direct contact with fire (24 percent), and burns (26\npercent) 3<\/sup>.<\/p>\n\n\n\n

Indonesia is rich in natural resources,\nincluding a wealth of plants with medicinal properties. The culture of using\nnatural ingredients as medicine has been implemented by society for a long\ntime, and the latest trend is towards a more natural lifestyle, so people are\nagain using various natural ingredients for treatment 4<\/sup>.\nMuch research has been carried out on beneficial plants in medicine. The use of\nmedicinal plants is a tradition that has been passed down from generation to\ngeneration. The use of natural ingredients as treatment continues to experience\nrapid growth in the field of medicine and modern medicine to date. One plant proven\nto have medicinal benefits is yellow root (Arcangelisia flava<\/em> (L.)\nMerr.) 5.<\/sup><\/p>\n\n\n\n

Yellow root (Arcangelisia flava<\/em> (L.)\nMerr.) is a native Indonesian plant that the community has widely used as a\nmedicine. Compounds in yellow root plants, including alkaloids, flavonoids, and\nsaponins, can accelerate burn healing 4<\/sup>.\nYellow root plant stem extract with a concentration of 0,025 percent can\naccelerate the wound healing process through anti-inflammatory mechanisms 5<\/sup>. In research conducted by 6<\/sup>, It was mentioned that\nthe yellow root plant stem extract at a concentration of 1 gram in 100 grams of\ntopical gel preparation gave optimal bacterial inhibition results. In addition,\nthe research conducted by 4<\/sup> mentioned that the yellow\nroot’s alkaloid, flavonoid, and saponin content has activity in epithelial cell\nproliferation.<\/p>\n\n\n\n

One treatment for\nburns can be done using conventional semisolid topical preparations such as\nointments, gels, and creams. However, these preparations have limitations when\napplied to the wounded skin 6<\/sup>. These limitations\ninclude the contact time between the preparation and the skin, which cannot\nlast long, is easily erased due to friction, and frequent use, which affects\ncompliance with the use of the preparation. Technological developments in the\nhealth sector encourage continued improvement of drug delivery systems to\novercome the limitations of previous preparations. Film Forming Hydrogel (FFH)\nis a topical preparation applied directly to the skin surface, leaving a thin\nlayer immediately after use. The development of Film Forming Hydrogel (FFH)\naims to overcome the problems found in previous preparations with the ability\nto absorb good wound exudate. In addition, the formed film has properties that\ncan follow the skin’s elasticity, providing comfort when used.10<\/sup><\/p>\n\n\n\n

The concentration of polymer used affects the characteristics of the film formed. The polymer concentration should be manageable because it can cause the film layer formed to be stiff and rigid, making it brittle and easily broken10<\/sup>. Meanwhile, the film formed will have good resistance if the polymer concentration increases. Film Film-forming hydrogel (FFH) from ethanol extract of yellow root plant stems is made in 9 formulas, namely, F1, F2, F3, F4, F5, F6, F7, F8, and F9. These formulas have the same plasticizer and solvent concentrations but different concentrations of active ingredients and polymers to see the effect on the physicochemical characteristics of the preparations made and their stability. The active ingredient used in the FFH preparation is yellow root extract (Arcangelisia flava (L.) Merr.) with a concentration of % (0,5; 1; 1,5). Meanwhile, the polymers used in the formula are PVP and PVA with a concentration ratio of % (2,8: 15,2; 2,8: 17,2; 2,8: 19,2). Therefore, this study aims to obtain a formula with good physical and chemical characteristics of FFH preparations using variations in the concentration of PVP-PVA polymers and extract concentration. <\/p>\n\n\n\n

Material and methods<\/strong><\/p>\n\n\n\n

Extraction of yellow root plant<\/strong><\/p>\n\n\n\n

The extraction of yellow root plant stems was conducted using Ultrasound-Assisted Extraction (SONICA) using 70% ethanol solvent (PT. Bratachem). The extraction was performed with a solvent ratio 1:10 for 10 minutes at 50o<\/sup>C. The filtrate that has been obtained is then filtered and concentrated using a rotary evaporator (IKA RV 10 Basic) at 400<\/sup>C and in the oven at 500<\/sup>C 8<\/sup>. In this extraction, a yield of 4.8 percent was obtained. The requirement for the yield of yellow root extract based on the Indonesian Herbal Pharmacopoeia is >3.5 percent. 7<\/sup><\/p>\n\n\n\n

Yield Calculation<\/strong><\/p>\n\n\n\n

The formula calculates calculation of the yield of yellow root extract: <\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

Preparation of Film Forming Hydrogel (FFH) <\/strong><\/p>\n\n\n\n

FFH formula consists of yellow root dry extract as the active ingredient, PVA-PVP as the polymer (PT. Bratachem), Propylene glycol as a plasticizer (PT. Bratachem), nipagin and nipasol as preservatives (PT. Bratachem), and distilled water as a solvent (PT. Bratachem). The preparation of FFH (Table 1) started with the preparation of hydrogel base (PVA-PVP), and the other components were mixed gradually. Stirring was done using a homogenizer (IKA) at 3000 rpm for 10 minutes 9<\/sup>.<\/p>\n\n\n\n

Table 1: Formula Film Forming Hydrogel<\/em> (FFH) yellow root extract (A.flava<\/em>)<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Name<\/strong><\/p>\n<\/td>\n

\n

Function<\/strong><\/p>\n<\/td>\n

\n

Concentration % (b\/b)<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

F1<\/strong><\/p>\n<\/td>\n

\n

F2<\/strong><\/p>\n<\/td>\n

\n

F3<\/strong><\/p>\n<\/td>\n

\n

F4<\/strong><\/p>\n<\/td>\n

\n

F5<\/strong><\/p>\n<\/td>\n

\n

F6<\/strong><\/p>\n<\/td>\n

\n

F7<\/strong><\/p>\n<\/td>\n

\n

F8<\/strong><\/p>\n<\/td>\n

\n

F9<\/strong><\/p>\n<\/td>\n

\n

F10<\/strong><\/p>\n<\/td>\n

\n

F11<\/strong><\/p>\n<\/td>\n

\n

F12<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Ekstrak<\/p>\n<\/td>\n

\n

Active compound<\/p>\n<\/td>\n

\n

0,5<\/p>\n<\/td>\n

\n

0,5<\/p>\n<\/td>\n

\n

0,5<\/p>\n<\/td>\n

\n

1<\/p>\n<\/td>\n

\n

1<\/p>\n<\/td>\n

\n

1<\/p>\n<\/td>\n

\n

1,5<\/p>\n<\/td>\n

\n

1,5<\/p>\n<\/td>\n

\n

1,5<\/p>\n<\/td>\n

\n

–<\/p>\n<\/td>\n

\n

–<\/p>\n<\/td>\n

\n

–<\/p>\n<\/td>\n<\/tr>\n

\n

PVP<\/p>\n<\/td>\n

\n

Polymer<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n

\n

2,8<\/p>\n<\/td>\n<\/tr>\n

\n

PVA<\/p>\n<\/td>\n

\n

Polymer<\/p>\n<\/td>\n

\n

15,2<\/p>\n<\/td>\n

\n

17,2<\/p>\n<\/td>\n

\n

19,2<\/p>\n<\/td>\n

\n

15,2<\/p>\n<\/td>\n

\n

17,2<\/p>\n<\/td>\n

\n

19,2<\/p>\n<\/td>\n

\n

15,2<\/p>\n<\/td>\n

\n

17,2<\/p>\n<\/td>\n

\n

19,2<\/p>\n<\/td>\n

\n

15,2<\/p>\n<\/td>\n

\n

17,2<\/p>\n<\/td>\n

\n

19,2<\/p>\n<\/td>\n<\/tr>\n

\n

PG<\/p>\n<\/td>\n

\n

Plasticizer<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n

\n

3<\/p>\n<\/td>\n<\/tr>\n

\n

Nipagin<\/p>\n<\/td>\n

\n

preservative<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n

\n

0,18<\/p>\n<\/td>\n<\/tr>\n

\n

Nipasol<\/p>\n<\/td>\n

\n

preservative<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n

\n

0,02<\/p>\n<\/td>\n<\/tr>\n

\n

Aquades<\/p>\n<\/td>\n

\n

Solvent<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad 100<\/p>\n<\/td>\n

\n

ad<\/p>\n

100<\/p>\n<\/td>\n

\n

ad<\/p>\n

100<\/p>\n<\/td>\n

\n

ad<\/p>\n

100<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n

Characteristic\nEvaluation of Film Forming Hydrogel (FFH)<\/strong><\/p>\n\n\n\n

Organoleptic <\/strong><\/p>\n\n\n\n

Organoleptic\ntesting is done by visually examining the preparation’s shape, color, and\nsmell.<\/p>\n\n\n\n

pH<\/strong><\/p>\n\n\n\n

The\npH test was conducted using a pH meter (Mettler Toledo) and repeated three\ntimes. The pH values that meet the criteria are 4-6 10<\/sup>.<\/strong><\/p>\n\n\n\n

Adhesiveness<\/strong><\/p>\n\n\n\n

The\nadhesion test was carried out by placing 0.5 g of preparation on a glass slide,\nthen covered with another glass slide and giving a load of 200 g for 5 minutes.\nDetermination of adhesion is done by calculating the time required until both\nglass objects are released. The requirement for the adhesion test is >4\nseconds 11<\/sup>.<\/p>\n\n\n\n

Spreadability<\/strong><\/p>\n\n\n\n

The\nspreadability test was carried out by placing 0.5 g of preparation on a round\nglass with a diameter, then covering it with another glass on top and leaving\nit for 1 minute. After one minute, weights of 50, 100, 150 g were given.\nDiameter measurements were taken after being given weights for 1 minute. The\nrequirements for the spreadability test are 5-7 cm 12<\/sup>.<\/p>\n\n\n\n

Viscosity <\/strong><\/p>\n\n\n\n

The\nviscosity of the preparation was measured using a tool viscometer Brookfield\nspindle 64. The viscosity test requirements are 7100-83144 cPs 13<\/sup>.\n<\/p>\n\n\n\n

Drying Time<\/strong><\/p>\n\n\n\n

The\ndrying time test on the formed film was carried out by applying the preparation\non a glass object that had previously been heated at 370<\/sup>C. The test\nparameters for drying time are <5 minutes 14<\/sup>.<\/p>\n\n\n\n

Mechanical\nProperties<\/strong><\/p>\n\n\n\n

Assessment\nof tensile strength and elongation can describe the film formed. The\ndescription of the film also describes its resistance to abrasion and\nflexibility. Assessment based on the mechanical properties of human skin\ndetermined the value of tensile strength and elongation of the film formed is\n5-32 Mpa and 30-115% 15<\/sup>.<\/p>\n\n\n\n

Stickiness <\/strong><\/p>\n\n\n\n

The\ntesting process is done by pressing the paper against the dry film with low\npressure. The film formed should stick to something other than the paper 16<\/sup>.<\/p>\n\n\n\n

Stability<\/strong><\/p>\n\n\n\n

Stability\ntesting of FFH using freeze-thaw method. FFH was stored for 24 hours at 40<\/sup>C\nand 24 hours at 400<\/sup>C 17<\/sup>.\nThis process is repeated for three cycles or six days 18<\/sup>.<\/p>\n\n\n\n

Data Analysis <\/strong><\/p>\n\n\n\n

Statistical analysis was carried out using\nparametric statistical tests, multivariate analysis using SPSS version 23\nsoftware. In order to know whether there was a significant influence between\nthe formulas, further analysis was carried out using the least significant\ndifference (LSD) with a confidence level of 95% (p-value <0,05).19<\/sup><\/p>\n\n\n\n

Results and Discussion<\/strong><\/p>\n\n\n\n

This research is developing a delivery system,\nnamely Film Forming Hydrogel (FFH), aimed at overcoming the problems found in\nconventional topical preparations such as gels, ointments, and creams because\nconventional preparations provide a fast contact period and are less stable in\nstorage. The use of FFH in wound therapy management can absorb wound exudate\nwell 20. In addition, the formed film has properties that can follow the skin’s\nelasticity, providing comfort when used 20<\/sup>.<\/p>\n\n\n\n

Characteristic\nEvaluation of Film Forming Hydrogel (FFH)<\/strong><\/p>\n\n\n\n

Organoleptic <\/strong><\/p>\n\n\n\n

Based on the organoleptic evaluation results,\nF7, F8, and F9 with 1.5 percent extract concentration have a darker color and a\nmore intense characteristic odor when compared to F1, F2, and F3 with 0.5\npercent extract concentration and F4, F5, F6 with 1 percent extract\nconcentration. FFH that meets the organoleptic requirements has a color like\nthe active substance, a distinctive aroma of the yellow root, and a thick\nappearance. <\/p>\n\n\n\n

The results of the dosage form observation\nshow that the formula can be poured with varying viscosity. This is due to the\nincrease in the viscosity of the preparation. By naked eye observation, the\npreparations with suitable viscosity are F1, F4, and F7 because they are not\ntoo thick and liquid.<\/p>\n\n\n\n

Table 2: Organoleptic evaluation results before and after stability test of formula 1 (F1)-formula 12 (F12) FFH preparation of yellow root extract (A. flava<\/em>)<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Formula<\/strong><\/p>\n<\/td>\n

\n

Observations<\/strong><\/p>\n<\/td>\n

\n

Stability<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Before stability test<\/strong><\/p>\n<\/td>\n

\n

After stability test<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

F1<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Yellow to light brown<\/p>\n<\/td>\n

\n

Yellow to light brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Yellow root characteristic odor<\/p>\n<\/td>\n

\n

Yellow root characteristic odor<\/p>\n<\/td>\n<\/tr>\n

\n

F2<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Yellow to light brown<\/p>\n<\/td>\n

\n

Yellow to light brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

thick gel-like<\/p>\n<\/td>\n

\n

thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Yellow root characteristic odor<\/p>\n<\/td>\n

\n

Yellow root characteristic odor<\/p>\n<\/td>\n<\/tr>\n

\n

F3<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Yellow to light brown<\/p>\n<\/td>\n

\n

Yellow to light brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Yellow root characteristic odor<\/p>\n<\/td>\n

\n

Yellow root characteristic odor<\/p>\n<\/td>\n<\/tr>\n

\n

F4<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Dark brown<\/p>\n<\/td>\n

\n

Dark brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n<\/tr>\n

\n

F5<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Dark brown<\/p>\n<\/td>\n

\n

Dark brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n<\/tr>\n

\n

F6<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Dark brown<\/p>\n<\/td>\n

\n

Dark brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n<\/tr>\n

\n

F7<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Blackish brown<\/p>\n<\/td>\n

\n

Blackish brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n<\/tr>\n

\n

F8<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Blackish brown<\/p>\n<\/td>\n

\n

Blackish brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n<\/tr>\n

\n

F9<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Blackish brown<\/p>\n<\/td>\n

\n

Blackish brown<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n

\n

Sharp odor typical of yellow root<\/p>\n<\/td>\n<\/tr>\n

\n

F10<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Yellowish white<\/p>\n<\/td>\n

\n

Yellowish white<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Typical odor of PVA polymer<\/p>\n<\/td>\n

\n

Typical odor of PVA polymer<\/p>\n<\/td>\n<\/tr>\n

\n

F11<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Yellowish white<\/p>\n<\/td>\n

\n

Yellowish white<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Typical odor of PVA polymer<\/p>\n<\/td>\n

\n

Typical odor of PVA polymer<\/p>\n<\/td>\n<\/tr>\n

\n

F12<\/p>\n<\/td>\n

\n

Color<\/p>\n<\/td>\n

\n

Yellowish white<\/p>\n<\/td>\n

\n

Yellowish white<\/p>\n<\/td>\n<\/tr>\n

\n

Shape<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n

\n

Thick gel-like<\/p>\n<\/td>\n<\/tr>\n

\n

Smell<\/p>\n<\/td>\n

\n

Typical odor of PVA polymer<\/p>\n<\/td>\n

\n

Typical odor of PVA polymer<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n

Organoleptic\ntest observations on FFH preparation were done twice before and after\nstability. After the stability test, the observation showed no change in the\npreparation’s color, odor, and shape. <\/p>\n\n\n\n

pH <\/strong><\/p>\n\n\n\n

The pH\nmeasurement was carried out using a pH meter. Topical preparations must have a\npH by the normal pH of the skin, namely 4-6 10<\/sup>.\nThe pH around the wounded skin tends to increase between 7-8. An alkaline pH\nwill inhibit wound healing, so a slightly acidic pH is required.<\/p>\n\n\n\n\n\n
\"\"<\/td>\n\n

Figure 1: Graph of pH measurement before and after stability test of formula 1 (F1)-formula 12 (F12) FFH preparation of yellow root extract (A. flava<\/em>).<\/strong><\/p>\n

<\/p>\n

Click here to view Figure<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

The pH test results show that all formulas\nmeet the pH range according to the standard, namely 4-6 20<\/sup>. It can be seen in the\ngraph that as the extract increases, the pH of the preparation will decrease.\nThis is because the pH of the extract is in the acidic pH range, namely 5.08.\nIn the pH testing graph after stability, the results show a decrease in pH. A\ndecrease in pH value during storage can occur due to the influence of CO2<\/sub>\nreacting with the water phase, so the pH tends to become more acidic 21<\/sup>.\nHowever, the decrease is still within the range of pH testing parameters. Based\non the results of LSD statistical analysis, there is a significant effect\nbetween the concentration of extracts and polymers on the pH of FFH\npreparations in pH measurement (p-value<\/em>\n<0,05). In addition, the concentration of extract and polymer also had a\nsignificant effect on the stability of the preparation (p-value<\/em> <0,05). <\/p>\n\n\n\n

Adhesiveness<\/strong><\/p>\n\n\n\n

Testing the adhesive power of the preparation\nis done to know the ability of the hydrogel preparation to adhere to the skin’s\nsurface when used. A good hydrogel preparation will produce adhesion of more\nthan 4 seconds 11<\/sup>.\nThe concentration of PVA influences the adhesive power used where the higher\nthe concentration of PVA, the longer the adhesive power will be 12<\/sup>.<\/p>\n\n\n\n\n\n
\"\"<\/td>\n\n

Figure 2: Graph of Adhesion Testing before and after stability test of formula 1 (F1)-formula 12 (F12) FFH preparation of yellow root extract (A. flava<\/em>).<\/strong><\/p>\n

<\/p>\n

Click here to view Figure<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

The adhesion test results showed that all\nformulas met the pH range according to the standard, namely >4 seconds 11<\/sup>.\nThe graph shows that the polymer concentration affects the adhesion of the\npreparation, where the greater the concentration of the PVP polymer ratio: PVA\npolymer ratio, the more the adhesion of the preparation increases. It can be\nseen in F3 at the concentration ratio of PVP: PVA (2.8: 19.2) percent has a\nhigher graph when compared to F1 at a concentration ratio of PVP: PVA (2.8:\n15.2) percent. After the freeze-thaw stability test, the adhesion of the\npreparation increased. This is because the viscosity of the preparation\nincreases after the stability test is carried out. The results of the LSD\nstatistical analysis show that the extract concentration has a non-significant\neffect (p-value<\/em>> 0,05) at 1\npercent of the extract concentration against F7, F8, and F9. 1.5 percent\nextract concentration against F4, F5, and F6. While the polymer concentration\ngives significantly different test results (p-value<\/em>\n< 0,05) against all formulas. As for stability, the concentration of extract\nand polymer had a significant effect (p-value<\/em>\n<0,05). <\/p>\n\n\n\n

Spreadability<\/strong><\/p>\n\n\n\n

The spreadability test was conducted to\ndetermine the ability of FFH preparations to spread when applied to the skin.\nIt is expected to spread quickly when applied so that the effect is evenly\ndistributed 22<\/sup>.\nHydrogel preparations that provide good spreadability are expected to have\nbetter wound healing effectiveness 23<\/sup>.\nSpread ability is related to the viscosity of the preparation, where the more\nsignificant the viscosity value of preparation, the more difficult it will be\napplied so that the ability of the preparation to spread quickly on the skin is\nalso lower. The greater the spreadability of the hydrogel preparation, the\nfaster it will penetrate the skin and show its effectiveness 22<\/sup>.\nSpread ability testing parameters are 5-7 cm 12<\/sup>. Spread ability that is\ntoo high (> 7cm) or too low (< 5cm) will make it difficult when the\npreparation is applied to the skin 12<\/sup>.<\/p>\n\n\n\n\n\n
\"\"<\/td>\n\n

Figure 3: Spread ability test graph before and after stability test of formula 1 (F1)-formula 12  (F12) FFH preparation of yellow root extract (A. flava<\/em>)<\/strong><\/p>\n

<\/p>\n

Click here to view Figure<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

The\nresults of the spreadability test of formulas that meet the spreadability test\nstandards of 5-7 cm 12<\/sup> F1, F4, and F7 with a\npolymer concentration ratio of PVP: PVA (2.8: 15.2) percent. Polymer\nconcentration affects the ability of the preparation to spread. The higher the\npolymer concentration used, the preparation’s spreadability will also decrease.\nAfter the stability test was carried out, the results obtained were that the\nspreadability of the preparation decreased. This shows that storage temperature\naffects the viscosity of the preparation. The thicker the preparation, the more\nthe spreadability of the preparation will decrease. Based on the results of\nLSD, statistical analysis shows a significant effect of differences in extract\nconcentration and polymer concentration on the results of the preparation\nspreadability test (p-value<\/em>\n<0,05). The stability test showed that the concentration of 1 percent\nextract had no significant effect (p\nvalue<\/em>>0.05) on F10, F11, and F12. At the same time, the polymer concentration\nhas a significant effect (p-value<\/em>\n<0.05).<\/p>\n\n\n\n

Viscosity<\/strong><\/p>\n\n\n\n

The viscosity test was conducted to determine\nwhether or not the FFH preparation was easy to apply. It shows the ability of\nthe preparation to flow. In addition, viscosity can be used as a stability\nparameter and affect the preparation’s spreadability and stickiness 23<\/sup>.<\/p>\n\n\n\n\n\n
\"\"<\/td>\n\n

Figure 4:<\/strong> Viscosity Testing Chart before and after stability test of formula 1 (F1)-formula 12 (F12) FFH preparation of yellow root extract (A. flava<\/em>)<\/strong><\/p>\n

<\/p>\n

Click here to view Figure<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

Based\non the table above, the results of viscosity testing on FFH preparation of\nyellow root extract produce different results. The higher the polymer\nconcentration, namely PVA, used, the greater the viscosity of the preparation.\nFormulas that meet the viscosity test standards 7100-83144 cPs 13<\/sup>\nare F1 and F7. This is because increasing the concentration of PVA can increase\nthe number of polymer fibers; besides that, PVA has properties that bind water\nso that much liquid is retained and pulled by PVA 24<\/sup>. After the stability test,\nthe viscosity increased. This change may be due to the effect of the polymer on\ntemperature changes. The last cycle test in the formula is at a cold\ntemperature of 40C. When preparation is stored at cold temperatures, the polymer\nchains will shorten and join each other to increase viscosity 25<\/sup>.\nBased on the results of LSD statistical analysis, it was found that 1 percent\nextract concentration did not have a significant effect (p value<\/em>>0.05) on formulas F10, F11, and F12. Polymer\nconcentration has a significant effect (p-value<\/em>\n<0.05). Meanwhile, the stability results showed that the concentration of 1\npercent extract had no significant effect (p\nvalue<\/em>>0.05) on formulas F10, F11, and F12. At the same time, the polymer\nconcentration has a significant effect (p-value<\/em>\n<0.05).<\/p>\n\n\n\n

Drying Time<\/strong><\/p>\n\n\n\n

The drying time test was conducted to see the\nability of FFH preparation to form a thin film on the skin surface shortly\nafter the preparation was applied. A good FFH preparation will enable the\nformation of a thin film within 5 minutes 14<\/sup>. The\nfaster the FFH preparation dries, the faster the active ingredients are\nreleased and penetrated. Based on the research journal conducted by the study10<\/sup>,\nit is stated that after the preparation is applied to the skin, the solvent\nwill evaporate, resulting in a thin film residue. When the solvent evaporates,\nthe drug will be released and penetrated. \n<\/p>\n\n\n\n\n\n
\"\"<\/td>\n\n

Figure 5: Drying time testing chart before and after stability test of formula 1 (F1)-formula 12 (F12) FFH preparation of yellow root extract (A. flava<\/em>).<\/strong><\/p>\n

<\/p>\n

Click here to view Figure<\/a><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n

The drying time test was done by applying the\npreparation to a glass object previously heated at 370<\/sup>C and then\ncounting until the preparation dried. Heating the glass object at 370<\/sup>C\naims to provide a temperature comparable to the average human body temperature\nin the 36.20<\/sup>C – 37.50<\/sup>C so that the film can dry. All FFH\nformulas of yellow root extract met the test standard of drying time <5\nminutes 14<\/sup> except in the control\nformula 1 (F10). The concentration of polymer used affects the drying time of\nthe preparation; when used with an increasing concentration, the drying time\nwill be faster 26<\/sup>.<\/p>\n\n\n\n

After\nthe stability test, the preparation’s drying time decreases; the preparation’s\nviscosity influences this. The thicker the preparation, the faster the drying\ntime will be because the solvent in the preparation is less, and the\nevaporation of the solvent is faster. Based on the results of LSD, statistical\nanalysis shows that the difference in extract concentration and polymer\nconcentration has a significant effect (p-value<\/em>\n<0.05). In the LSD statistical test on stability, the results showed that\nthe concentration of extract and polymer had a significant effect (p-value<\/em> <0.05).<\/p>\n\n\n\n

Stickiness<\/strong><\/p>\n\n\n\n

The stickiness test is carried out to\ndetermine whether the film formed has sticky properties. This test is done by\nattaching a piece of paper pressed on the box with the film. The film is said\nto be good if not sticky on the paper’s surface 16<\/sup>. <\/p>\n\n\n\n

Tabel 3: Stickiness Testing Results before and after stability test formula 1 (F1)-formula 12 (F12) FFH preparation of yellow root extract (A. flava<\/em>)<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

Formula<\/strong><\/p>\n<\/td>\n

\n

Before Stability Test<\/strong><\/p>\n<\/td>\n

\n

After Stability Test<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

F1<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F2<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F3<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F4<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F5<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F6<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F7<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F8<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F9<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F10<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F11<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n

\n

F12<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n

\n

No film sticking<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n

The\nresults of sickness testing showed that all formulas fulfilled the stickiness\ntest; no film was attached to the paper’s surface. This shows that when the\npreparation is applied to the skin surface, it does not cause discomfort\nbecause it is easy to stick to clothes or fabrics. In the stickiness test, it\nwas found that there were no changes in all formulas from the stickiness test\nresults after the freeze-thaw stability test was carried out.<\/p>\n\n\n\n

Mechanical Properties<\/strong><\/p>\n\n\n\n

Plasticizers play an essential role in\nproviding flexibility to the film and increasing the tensile strength of the\nfilm formed. The choice of plasticizer must be tailored to the type of polymer\nused and have a low level of permeability to the skin. Common plasticizers\ninclude glycerin, propylene glycol, polyethylene glycol, and sorbitol 10<\/sup>.<\/p>\n\n\n\n

Table 4: Evaluation results of mechanical properties before and after stability test of formula 1 (F1) FFH preparation of yellow root extract (A. flava<\/em>)<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n
\n

Formula<\/strong><\/p>\n<\/td>\n

\n

Elongation (Mpa)<\/strong><\/p>\n<\/td>\n

\n

Tensile Strength (%)<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

R1<\/p>\n<\/td>\n

\n

2,9<\/p>\n<\/td>\n

\n

30,00<\/p>\n<\/td>\n<\/tr>\n

\n

R2<\/p>\n<\/td>\n

\n

3,5<\/p>\n<\/td>\n

\n

43,33<\/p>\n<\/td>\n<\/tr>\n

\n

R3<\/p>\n<\/td>\n

\n

4,2<\/p>\n<\/td>\n

\n

60,00<\/p>\n<\/td>\n<\/tr>\n

\n

Rerata\u00b1SD<\/p>\n<\/td>\n

\n

3,53\u00b10,650<\/p>\n<\/td>\n

\n

44,44\u00b115,030<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n

Assessment of tensile strength and flexibility\ncan describe the film formed. In addition to the description of the film\nformed, it also describes the film’s resistance to abrasion and its\nflexibility. Based on the graph of the tensile strength and flexibility test\nresults in Formula 1, the results are 3.53 N and 44.44 percent. <\/p>\n\n\n\n

The FFH research has been widely developed\nusing the active ingredients 27<\/sup>, pepper extract, and cloves 27<\/sup>.\nIt is essential to pay attention to the use of polymer concentration in the FFH\nsystem because it can affect the physical and chemical properties of the FFH\npreparation. They used concentration (%) of PVP and PVA polymer with a ratio of\n2.8:17.2 to produce FFH preparations with optimal characteristics. In this\nstudy, variations in concentration (%) of PVP and PVA were carried out within\nlimits30<\/sup>. The lowest and highest are at a ratio of 2.8:15.2,\n2.8:17.2, and 2.8:19.2. The use of polymers influences the characteristics of\nthe Film film-forming hydrogel (FFH) preparation, including formation time,\nadhesion, pH value, viscosity, spreadability, stickiness 28<\/sup>. <\/p>\n\n\n\n

Mechanical properties are affected by the type\nand amount of polymer. Concentrations that are too low cause discontinuous film\nformation, while concentrations that are too high produce stiff films, causing\ndiscomfort when applied. The improvement of mechanical properties is also\ninfluenced by adding plasticizers, which can increase the voids between polymer\nchains, thus increasing their mobility 15<\/sup>.<\/p>\n\n\n\n

This research focuses on formulation so\nfurther research is needed regarding its effectiveness in healing burn wounds\nthrough pre-clinical trials using experimental animals. Besides that in-depth\nstudy of formulations related to additional materials, especially the types of\npolymers used which can influence the physical and chemical characteristics of\nFilm Forming Hydrogel (FFH) preparations.<\/p>\n\n\n\n

Conclusion  <\/strong><\/p>\n\n\n\n

The best Film Forming Hydrogel (FFH) preparation was shown\nin F1 with an extract concentration of 0,5 % and a concentration of polymers (%)\nof PVP and PVA (2,8:15,2), which met the physicochemical characteristics test\nwhich included a semisolid form with a characteristic odor. Yellow root extract\nis yellow to light brown, pH 5,58 \u00b1 0,026, spreadability 5,45 \u00b1 0,01, adhesive\npower (seconds) 1,02 \u00b1 0,25, drying time (seconds) 3,95 \u00b1 0,67, stickiness\nindicates no film adheres to the fiber, viscosity (Cps) 7120 \u00b1 9078.58,\nelongation (Mpa) 3,53 \u00b1 0,65, tensile strength (%) 44,44 \u00b1 15,03. In line with\nexisting theory, variations in the concentration (%) of PVP and PVA polymers (2,8:15,2;\n2,8:17,2; 2,8:19,2 ) have a significant effect (p-value <0, 05) on the\nphysical and chemical characteristics as well as the stability of the\npreparation which requires further development of this research on wound\nhealing activities.<\/p>\n\n\n\n

Acknowledgments<\/strong><\/p>\n\n\n\n

The authors also wish\nto thank the Pharmacy Department of State Islamic University, Maulana Malik\nIbrahim of Malang, for providing the facilities to conduct this study. <\/p>\n\n\n\n

Conflict of Interest<\/strong><\/p>\n\n\n\n

The authors declared no conflict of interest.<\/p>\n\n\n\n

Funding Sources<\/strong><\/p>\n\n\n\n

This research was funded by the Faculty of Medical and Health Science, Universitas Islam Negeri Maulana Malik Ibrahim Malang superior faculty research collaboration between lecturers and students based on dean decision number 0910\/FKIK\/05\/2023. <\/p>\n\n\n\n

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