INTRODUCTION:

Starch is the most common type of carbohydrate and occurs naturally as a semi-crystalline polymer.¹ It is frequently utilized in the food and non-food industries since it is abundant, renewable, and biodegradable.² Starch properties can vary in chemical structures and functional properties depending on botanical origin. The physical and chemical characteristics of starches, including amylose content, size, and shape of granules, significantly affect their compression and tablet-forming capabilities.³

For tablet formulation in pharmaceuticals, starch in its native form is a safe, cheap, and biodegradable material that exhibits the majority of the characteristics of good tablet excipients.

Corn, wheat, and rice are the most common sources of starch utilized in pharmaceutical development, which represent a varied range of botanical species and qualities but, among the common sources, corn starch is mostly used in medicinal tablets.⁴ Aside from these, there are different unidentified sources with good economic potential and attractive characteristics that can be used to meet specific functional requirements. The starch from potatoes can act as a versatile excipient in pharmaceutical products, serving as a disintegrant, binder, or filler⁵ and native potato starch shows better disintegrant capacities than microcrystalline cellulose, which is used in tablet formulations.

Potato (Solanum tuberosum L.), is a starch-rich tuberous crop that is used worldwide as a food and supplies raw materials to the food and non-food industries. It is a key staple food worldwide, consumed in fresh and processed form.⁶ The top ten potato-producing countries are China, India, Ukraine, the Russian Federation, the United States of America, Germany, Bangladesh, France, Pakistan, the Netherlands, and Canada.⁷ Potato has frequently been cited as a perfect example of a carbohydrate-rich product with numerous nutritional benefits. The chemical and nutritional content of potato tubers varies depending on the type of soil, varieties, preharvest caring, growth seasons, storage, and different analysis methods. Potatoes are comprised of water (more than 70%), carbohydrates (16-24%), proteins (4%), anthocyanins, minerals, and other nutrients⁸ such as a small amount of lipids (approximately 0.15g/150 g), and predominant in vitamin C.

Potato starch has a number of unique qualities that make it an important ingredient in food and non-food industrial uses. One of its distinguishing features is its granular size distribution, which may vary greatly, influencing properties like as swelling power, water-holding capacity, and pasting behavior.⁹ The amylose content of potato starch is also important in defining its texture and stability; higher amylose quantity is linked with firmer gels and faster retrogradation. Furthermore, the pasting characteristics of potato starch, which are influenced by parameters such as granule size and pH during modification, are important for its applications because they influence the viscosity and texture of starch-based products.¹⁰ Overall, the physicochemical features of potato starch, including its gelatinization enthalpy and swelling capacity, are vital for its functioning both in culinary and industry applications.

Paracetamol, a para-aminophenol, offers short relief for low to severe pain and fever. Chemically, it's 4'-hydroxyacetanilide or N-(4 hydroxyphenyl) acetamide.¹¹ It is a non-steroidal analgesic and antipyretic medication with few side effects.¹² Paracetamol is available in several dose forms, including tablets, capsules, drops, elixirs, suspensions, and suppositories¹³, and the Indian and British Pharmacopoeias recognize paracetamol as an official medicine.¹⁴

The oral route is a popular way to administer medications. Tablets are a widely favoured form of medication that is taken orally. They are highly regarded for their simplicity in production, ease of use, precise dosage, superior stability in comparison to liquids, and resistance to tampering.¹⁵ Tablet formulation technology has undergone significant advances during the past few decades. At present, there is a shift towards adopting multipurpose excipients, which helps to reduce processing steps/time, the amount of excipients, and the possibility of interaction between tablet components. Wet granulation is a popular granulation process in tablet production. Wet granulation is the process of rubbing combined dry primary particles of powder and a granulation fluid.¹⁶ The solvent used in the granulation solution must be volatile to be evaporated during drying. Water, isopropanol, and ethanol are popular solvents that can be used separately or in combination. This is the most flexible and commonly utilized granulation procedure in the pharmaceutical field. The Direct compression (DC) method produces tablets directly from a drug-excipient mixture, with no additional processing. DC is an easy and inexpensive approach that works effectively with moisture-sensitive material. However, the efficacy of DC tablet formulations is determined by the physicochemical qualities of the excipients utilized.¹⁷Compressed tablet quality is assessed based on factors such as weight uniformity, drug content uniformity, crushing strength, disintegration time, friability, and in-vitro dissolution. The parameters are measured using a variety of tests, some of which are detailed in approved official compendia. A tablet is considered good quality if it meets all relevant requirements in the official compendia.¹⁸ Corn starch is generally commercially used as an excipient in tablet making. However, starches from other botanical sources are rather scarcely used for making tablets. Exploring the possibility of utilizing starch from diverse botanical sources for making tablets may lead to the formulation of tablets with desired properties. In the quest, the study is carried out to explore the possibility of using potato starch in tablet formulation.

MATERIAL AND METHODS:

Materials:

Potatoes and drug (paracetamol) were purchased from the local market of Bathinda (Punjab), India.

Methods:

Isolation of starch:

Potato starch was extracted using the juice-extracting method, with minor changes.¹⁹ Pre-cured potatoes (500g) were cleaned, peeled, and cut into small (1cm x 1cm) pieces. The cut pieces were soaked in sodium metabisulfite (0.01% w/v). The juice was obtained by crushing potato chunks using a juicer or mixer (50g pieces: 50g distilled water) for 2-3min. After passing through a 200mesh sieve, the extract was allowed to settle at the refrigerated temperature. After 24hours, the extra water was decanted, and the procedure was carried out 2-3 times to obtain pure starch at the bottom. The obtained starch was dried at 40°C in a tray drier. Dried starch was stored with the help of sealable plastic pouches in airtight containers.

Physiochemical properties:

a) Amylose content:

The starch and 0.5N KOH solution were thoroughly mixed together. The material was subsequently poured into a 100 ml volumetric flask and diluted to the desired concentration using distilled water. A portion of the test blend starch solution (10 ml) was carefully transferred into a 50ml volumetric flask. Next, a precise amount of 0.1N HCl (5ml) and an amount of iodine (0.5ml) had been added. The solution was diluted to 50ml and its absorbance was measured at 625nm using an ultraviolet spectrophotometer (UV 1800 Shimadzu Corporation, Japan).²⁰

b) Swelling power and solubility:

A quantity of 0.5 grams of starch was combined with 50 ml of distilled water. The mixture was then placed in a centrifuge tube that had been weighed beforehand. The tube was heated at a temperature of 90°C in a water bath (RG 100-17, Vasai, India) for approximately 30 minutes. The heated material was cooled to room temperature and then subjected to centrifugation at 3000 rpm for 15 minutes using a Remi C-24 Plus centrifuge from India. The liquid portion was moved into a petri dish that had been weighed beforehand and then subjected to drying in a hot air oven set at a temperature of 100℃. SP was determined by calculating the percentage of weight gain in the sample. The swelling solubility was determined by measuring the proportion of dry particles in the supernatant.²⁰

c) Water holding capacity:

In a centrifuge tube, 1g of starch and 20ml of distilled water were mixed. After 30 min of standing at 30°C, the samples were centrifuged (3000rpm/10min). After separating the supernatant, the water-holding capacity of the sediment was evaluated directly by weighing.²⁰

Morphological properties:

Scanning electron microscopy (SEM):

Scanning electron micrographs were captured utilizing a scanning microscope (Jeol JSM-6100, Tokyo, Japan). Starch samples were dissolved in ethanol to create a 1% solution. An aluminum stub was used to hold a small amount of starch-ethanol solution, which was then covered with a layer of gold-palladium (60:40) coating. The micrography was conducted using an accelerated potential of 15kV.^10,21

Thermal properties:

Differential scanning calorimetry (DSC):

The thermal characteristics of natural starch were assessed using a differential scanning calorimeter (Mettler Toledo, Switzerland). A 3.5mg sample of starch was placed in a 40μL aluminum pan. Distilled water was then added using a Hamilton micro needle to create a starch-water solution with a water content of 70%. The samples were airtight sealed and allowed to rest at ambient temperature for 30 minutes before being heated in the DSC. The device was calibrated using indium, with an empty aluminum pan used as a reference sample. The sample pans were warmed at a rate of 10°C per minute. The computer autonomously calculated the initiation temperature (To), maximum temperature (Tp), final temperature (Tc), and gelatinization enthalpy (ΔHgel).²¹

Preparation of granules:

Granules were made by employing the wet granulation technique. The substances utilized for granulation were starch, lactose, magnesium stearate, talcum powder, and paracetamol medication. The indicated ingredients (Table 1) for stage 1 are accurately weighed and thoroughly mixed before passing through sieve no. 60. Add the PVP K30 binder solution slowly. Pass the mixed mass through sieve no. 20 to create granules, then dry them out in hot air oven (50⁰C/90-120 min). Now, add magnesium and talc stearate to the dried granules and pass them through sieve number 10.

Table 1: Formula of paracetamol tablet containing potato starch sample as disintegrant.

S. No	Ingredients	Quantity Taken For 100 Tablets	Quantity Taken For Each Tablet
Pre-granulation (Stage 1)
1.	Paracetamol	25 gm	250 mg
2.	Lactose	1.56 gm	15.6 mg
3.	Different starch samples (10%)	3 gm	30.0 mg
Granulation (Stage 2)
1.	Binder solution, [PVP In aqueous solution, 10% w/v]	q.s	q.s
Pre-compression (Stage 3)
1.	Talc	0.3 gm	3.0 mg
2.	Magnesium stearate	0.15 gm	1.50 mg

Micrometric properties of granules:

The micromeritic characteristics of starch were evaluated (bulk density, tapped density, angle of repose, Carr's index, and Hausner's ratio). All of these qualities were tested using the methodology.²²

a) Bulk density:

Bulk density is defined as a measure of a powder's weight to its bulk volume. For powdered samples, it can be estimated using the distribution of particle sizes, particle shape, and particle-granule adhesion. Approximately 40g of sample was placed in a measuring cylinder (100 ml). The cylinder was gently filled, the level of granules was adjusted without compressing, and the apparent volume was determined. Bulk density was calculated as grams per ml.

Weight of Granules

Bulk Density= ------------------------------

Volume of the Powder

b) Tapped density:

Tapped density is the density acquired by tapping the bulk amount in a measuring cylinder. For tapped density, the weighted quantity (40 g) of prepared granules in a measuring cylinder was taken and tapped 300 times on the table's hard surface, after which the volume was observed and calculated using the given formula:

Weight of Granules

Tapped Density = ------------------------

Final Volume tapped

c) Hausner’s ratio:

The tapped density to bulk density ratio, or Hausner's ratio, reflects powder flow ability. It was calculated with the following formula:

Tapped density

Hausner’s ratio = ----------------------

Bulk density

d) Carr’s index:

It is defined as the compressibility of powder mix, which was estimated with the formula:

Tapped density - Bulk density

Carr’s index = ----------------------------------- x 100

Tapped density

e) Angle of repose:

The angle of repose was measured by enabling the powder to pass through a funnel before settling freely on a surface. When the pile reached the funnel's tip, the addition of the sample was discontinued. A circle was drawn over a pile with no movements. The height and diameter of the formulated cone were measured three times, and the average result was obtained by using the following equation:

Tan θ= h/r or θ = tan^-1(h/r)

(where, h= height of the powder cone; r = radius of the powder)

Preparation and evaluation of tablet:

The tablet was created by punching the granules with a tablet punching machine (AE-347-IV, Amar Enterprise, India).

Evaluation of prepared tablets:²³

a) Appearance:

Appearance is one of the primary quality characteristics used to determine tablet acceptance. Consumer fulfillment is heavily influenced by the brand's overall elegance and identity.

b) Diameter and thickness:

To determine thickness and diameter, 10 tablets were randomly selected. The thickness and diameter of every tablet were determined with a digital vernier caliper. The average value was calculated by taking the mean of 10 tablets.

c) Weight variation:

Twenty tablets were taken randomly for weight measurement individually with an electronic weighing scale (Mettler Toledo, India). The result was computed using the following formula:

Average weight – Individual weight

% Deviation = ------------------------------- x 100

Avarage weight

d) Hardness:

The ability of a tablet to sustain a load is known as hardness. The tablet's hardness indicates its breaking strength, which was evaluated with a Monsanto hardness analyzer. A tablet was put between a stable anvil and a movable jaw, and the pressure was gradually applied till the tablet was fractured. At this point, the load indicates tablet hardness in kilogram-force. The hardness of the five tablets was measured, and an average was obtained.

e) Friability:

Ten pre-weighed tablets were dropped in the container of a friability (AE-282, Gupta Instruments Pvt. Ltd.) that mixer rotated at 25rpm 100 times. The spinning sample of tablets was then pulled out, and reweighed after de-dusting. Their reduction in percentage weight was estimated using the following formula:²⁴

Initial weight of tabt- Final weight of tabt

% Friability = ----------------------------------------- x 100

Initial weight of tabt

f) Disintegration time:

The disintegration time of tablets was evaluated using a disintegration test instrument (AE-281, Ambala, India). Six pills were chosen at random and put into the tubes that were part of the basket stacked in the beaker. The beaker was filled with a phosphate buffer solution (pH 6.8, 37°C). A regular motor driver was utilized to move the entire basket component up and down (5-6cm/28-32 cycles/min rate). Disintegration time was recorded manually.

g) in-vitro drug dissolution:

Tablets were dissolved in a 900ml dissolving buffer solution (sodium phosphate dibasic anhydrous and sodium phosphate monobasic dihydrate). The dissolution media was kept at 37±2℃ with a pH of 6.8. The agitation rate was 50rpm. Samples from the dissolution solution were taken every 0, 5, 10, 15, 20, 25, 30, 45, and 60min. The removed sample was changed with an equal quantity of fresh buffer on the previous pH and temperature. The sample was diluted appropriately, and the quantity of active components was evaluated by spectrophotometer (UV 1800, Shimadzu Corporation, Japan).²⁵

Statistical analysis:

The data in all tables were analysed using Minitab Statistical Software version 15 for one-way ANOVA.

RESULTS AND DISCUSSION:

Physiochemical properties:

Potato starch showed amylose content of 20.6% (Table 2). The total amylose content of the potato starch varies from 17.2 to 23.7%.²⁶ Amylose considerably influences the functional qualities and possible uses for starch.²⁷ Amylose content is closely connected with enzyme susceptibility, pasting, and heating characteristics, as well as the swelling and solubilization capabilities of starches.²⁸

The swelling power (SP) and solubility (S) behavior of starches are explored for improved knowledge of the connections between water molecules and chains of starch across amorphous and crystalline areas after heating.²⁹ These are the features of starch that respond directly to temperature variations. The swelling power displays the starch granules' ability to absorb water during starch swelling. The S and SP of potato starch are shown in Table 2. At 90°C, potato starch exhibited a swelling power of 40.74g/g and a solubility of 7.06%. In studies, it is reported that the potato starch's swelling power and solubility as 35.1g/g and 9.7%, and swelling power is 22.54 to 30.76g/g, respectively.^{10, 30} The SP of starch is directly proportional to the amylopectin and phosphorus concentration, while amylose works as a diluent and swelling inhibitor. Amylopectin is responsible for the granule's swelling, and also the fundamental structural substance of different regions of starch granules.³¹ The solubility of starch is a result of the process where amylose is released from the granules as they swell.³²

Water holding capacity (WHC) is the quantity of water retained per gram of dry matter in a sample. Because of differences in the accessibility degree of water-binding sites, starch has a larger WHC. The WHC is higher in starch where both amylopectin and amylose are loosely bound.³³ The observed WHC of starch is shown in Table 2. The value observed in the study is lower than the earlier investigation of the WHC of potato starch, which was reported at 91.3%.³⁴ The primary source of variations in water binding capacity found in current and earlier studies may be related to various kinds of cultivars and growing conditions that might influence the chemical composition and functional qualities of starch.

Table 2: Amylose content (%), Swelling power (g/g), Solubility (%), and Water absorption capacity (%) of starch (Values in mean±SD)

Starch Sample	Amylose content (%)	Swelling power (g/g)	Solubility value (%)	Water holding capacity (%)
Potato	20.6±0.09	40.74±0.17	7.06±0.4	74.95±0.16

Morphological properties:

Scanning electron microscopy (SEM):

Starch morphology varies based on genotype and growing method. The size and shape of granulars of starch vary depending on their biological origin. The chemical composition of the amyloplast or chloroplast, as well as the plant's physiology, determine the structure of starch granules.³⁵ SEM can analyze the form and structure of starch granules. Figure 1 shows SEM results of potato starch at 270, 1000, 10,000, and 20,000X magnification. The SEM analysis revealed that granules of potato starch were smooth, oval in shape, and irregularly formed, with sharp angles and edges. Studies on potato starch granules also revealed that they are oval, irregular, or cuboidal in shape.³⁶

Figure 1: Scanning Electron Micrograph of potato granules at 270, 1000, 10000, 20000X.

Thermal properties:

Differential scanning calorimetry (DSC):

Table 3 shows the thermal analysis findings for potato starch, and Figure 2 depicts the thermal curve. The starch sample exhibited endothermic transitions, indicating that amylose and amylopectin within the starch granules had an internal order. The gelatinization enthalpy (ΔHgel J/g) and peak index of the potato starch showed values of 10.2J/g and 2.97mW, respectively. The term ΔH is used to describe the process of the double helices in starch breaking down when exposed to heat. A shorter external chain length (ECL) leads to a reduction in ΔH during gelatinisation. An increase in the amount of phosphorus in starch may result in higher gelatinization temperatures.³⁷ The thermal characteristics (To-61.1 and 62.92°C, Tp-65.0 and 66.14°C, Tc-70.04 and 76.87°C, and ΔH of 16.6 and 13.55 J/g) have been reported earlier for potato starch.^38,39

Table 3: Thermal properties of potato starch

Starch sample	To (°C)	Tp (°C)	Tc (°C)	ΔHgel (J/g)	PHI (mW)
Potato	60.38	63.81	67.89	10.2	2.97

Figure 2: DSC of Potato starch

Granules and tablet evaluation:

Analysis of granules:

The size of particles plays an important role in granule characteristics. Larger particles result in less hard tablets because they contain lower surface areas for forming bonds than tiny particles.⁴⁰ So, to achieve optimum flow characteristics, compaction, and hardness, the uniformity of particle size must be optimized. The size of the granules of paracetamol increased with an increase in the binder's concentration. This could indicate that the binding mechanism of PVP K30 has changed. There were substantially fewer tiny particles, indicating that the granules might have beneficial flow characteristics.⁴¹ A low Carr's index indicates a suitable packing design with a minimal void volume and its value of <10 or Housner's ratio of <1.11 represents a 'very good' flow, Carr's Index between 11-15 or Hausner's Ratio between 1.12-1.18 is considered 'good' flow; Carr's Index between 16-20 or Hausner's Ratio between 1.19-1.25 is considered 'fair' flow; Carr's Index between 21-25 or Hausner's Ratio between 1.26-1.34 is considered as ‘passable’ flow; Carr's Index between 26-31 or Hausner's Ratio between 1.35-1.45 is assessed as 'poor' flow; and Carr's Index between 32-37 or Hausner's Ratio between 1.46-1.59 is taken in 'very poor' flow, and Carr's Index >38 or Hausner's Ratio >1.60 indicates a ' very bad' flow.⁴² Table 4 shows that granules produced with starch (potato) had good flow characteristics. The bulk density, tapped density, Hausner's ratio, Carr's index, and angle of repose of potato starch granules were 0.354g/ml, 0.431g/ml, 1.14, 15.24%, and 22.72°, respectively. Based on the statistics, it can be stated that Hausner's ratio and Carr's index fall under the range of acceptable flow qualities.

Table 4: Characterization of potato starch granules (Values in mean±SD)

Parameters	Potato starch granules
Bulk density (g/ml)	0.354±0.025
Tapped density (g/ml)	0.431±0.05
Hausner’s ratio	1.14±0.036
Carr’s index (%)	15.24±0.7
Angle of repose °	22.72±0.21

Evaluation of prepared tablets:

The uniformity of weight, thickness, and diameter indicates the active pharmaceutical ingredient (API) amount in the tablets. But, it is not guaranteed that the API will be homogeneous throughout all tablets, particularly in formulations with low dosage concentrations. Furthermore, if the weights, thickness, or diameters of tablets in the same batch vary, there can be variances in disintegration and dissolutions. The formulated tablets don’t vary in diameter, thickness, and weight (Table 5).

The hardness test of the tablets shows the capability to wear the stress and pressure during their handling and determine their deformation resistance. Furthermore, a tablet's mechanical strength affects the disintegration time and its rate of dissolution. A tablet's mechanical strength must be at least 4kg/cm² to be considered adequate.⁴³ Hardness reported for prepared tablets was 4.42kg/cm². The tablets' hardness ranged from 4-5 kg/cm².⁴⁴ Hardness can impact tablet disintegration and may require pressure modifications on the compression machine. If the tablet hardness is excessively high and the disintegration time does not fall within the limit, then tablets are rejected, if the disintegration stays within the limit the tablets are approved. If the tablet is overly soft, it cannot survive handling later in processing such as coating or packing.⁴⁵

A friability test ensures tablets can endure destruction during transport. The prepared tablets of potato starch have a friability of 0.39% (Table 5). Tablets pass the test with weight loss or friability of less than 1%.^46,47 But tablets' high content of disintegrants leads to an increase in weight loss so, an increase in disintegrant concentration leads to more friable tablets. The tuber starch tablets have more friability than commercial starches.⁴⁸

The disintegration test determines how long it takes for a medicine to disintegrate in the presence of digestive juices. The disintegration test is useful for quality control and can also be an important indicator for drug release as well as for the quality control of various dosage forms.⁴⁹ The drug absorption rate can be determine by the disintegration of tablets before they enter a solution. The sample of potato starch tablets passed the test as they disintegrated in less than 15 minutes.⁵⁰ To improve patient compliance, chewable tablets should disintegrate if not chewed completely and be robust enough for proper handling and transport.⁵¹ Disintegration studies for chewable tablets are essential as the dose form must disintegrate before drug release. To increase the dissolving rate, utilize surfactants, cyclodextrin complexation, and water-soluble solid dispersions. However, not all patients chew tablets equally, which will affect the medicine's bioavailability.⁵²

Table 5: Physical parameters of tablets prepared using potato starch (Values in mean±SD)

Parameters	Potato starch tablets
Appearance	White
Shape	Circular
Thickness(mm)	4.16±0.17
Diameter (mm)	8.25±0.05
Weight variation (mg)	329.7±0.21
Hardness (kg/cm²)	4.42±0.03
Friability (%)	0.39±0.02
Disintegration time(min)	2:14±0.14

In-vitro drug dissolution:

Super-disintegrants are commonly used by formulation scientists to develop fast-disintegrating tablets and improve the dissolving of active medicinal components in solid dosage forms.⁵³ The drug’s dissolution rate can be evaluated by the disintegrant's wetting time. Figure 3 represents the drug release characteristics of prepared tablets formulated incorporating potato starch and paracetamol drugs. The experiment was run for 60 min at a pH of 6.8 in a buffer solution of phosphate. The amount of drug released from potato starch tablets in the initial stage (after 5 minutes) was 32.78%. In between the stages with intervals of 5, 10, and 15 minutes, reading was recorded after each stage. After 60 minutes, the tablet (potato starch tablets) was entirely dissolved, and 98.56% of the drug was released. Drug delivery systems aim for successful drug delivery, with nearly 90% of drugs administered to treat disorders and diseases. This method is considered safe, convenient, and cost-effective, with high patient compliance.⁵⁴ Studies also concluded that drug release in tuber starch was higher as compared to commercial starch.⁵⁵ A drug's rate of dissolution impacts its absorption, therapeutic result, and effectiveness. The study indicated that using potato starch as a disintegrant significantly increased the percentage of the concentration of dissolved medication.

Figure 3: In-vitro drug dissolution graph of potato starch

CONCLUSIONS:

The research investigated several properties of starches to promote their use as potential excipients in tablet formulation. Different properties were examined, including amylose concentration, swelling power, solubility, water-holding capacity, scanning electron microscopy, and differential scanning calorimetry. The results showed that the tested starch used as intra-granular disintegrating agents, at a concentration of 10% w/v, produced paracetamol tablets with acceptable physical qualities. Hausner's ratio and Carr's index of prepared granules were within the permitted range of flow characteristics. The produced tablet's hardness and friability were in the acceptable range. The examined tablets demonstrated more than 80% of the medication dissolved in buffer solution within 30 min. Furthermore, based on the obtained results, potato starch can be utilized for tablet formulation.

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Received on 28.08.2024 Revised on 06.12.2024

Accepted on 08.02.2025 Published on 05.09.2025

Available online from September 08, 2025

Research J. Pharmacy and Technology. 2025;18(9):4482-4490.

DOI: 10.52711/0974-360X.2025.00643

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