INTRODUCTION:

Today's regulated drug delivery approach employs a variety of scientific techniques for customised treatment. The medication delivery method offers several advantages over traditional dosage, such as greater efficacy, reduced toxicity, customer compliance, and convenience. This approach provides treatment medicines via small molecules.

Many drugs seek to keep therapeutically effective and harmless blood or tissue levels. Proper dosing regimen design aids in this purpose.^1-3 Dosage form design aims to improve medicine distribution and therapeutic impact in unpredictable drug release environments. This is achieved by increasing availability or absorption speed. Formulation control involves reducing bioavailability to limit absorption rates. Common oral dosage structures include microspheres or miniature globules, which distribute medication more consistently in the gastrointestinal tract, retain it, reduce inflammation, and eliminate digestive polymeric material maintenance.^4-6

Hydroxyzine HCl (C23H43N3O5) is an angiotensin converting enzyme inhibitor that treats hypertension and congestive heart failure. Oral hydroxyzine HCl bioavailability is low. Hydroxyzine HCl is immediately taken orally. The drug undergoes substantial first-pass hepatic metabolism. This study produces a controlled release Hydroxyzine HCl dosage form utilising multiple polymers, lasting up to 12 hours.^7-9

MATERIALS AND METHODS:

Yarrowchem Pvt. Ltd. of Mumbai, India sent a free sample of Hydroxyzine HCl. We bought sodium alginate from Loba Chem, poliglusam from Yarrow Chem, glutaraldehyde, and zinc sulphate from S.D. Fine Chem. Any residual mixes were analysed.

Preparation with its Isolation of Tintiri Mucilage:

Tintiri seeds were dried in the sunshine till dry. The dried seeds were stirred in boiling water for up to 6 hours to remove mucilage and turn the water whitish-brown. The solution was chilled overnight to settle the particles. The next day, a cotton cloth was used to filter the solution until it was absolutely clear. Mucilage was separated from the filtrate by treating it with pure acetone. After another CH3)2CO wash, the gum was dried at room temperature for 24 hours.¹⁰ After drying, the gum was crushed, filtered through a #10 sieve, and stored in a desiccator.

Standard Calibration Curve:

100mg of Hydroxyzine HCl was carefully weighed into a 100 ml standard flagon, and the volume was adjusted with a pH 6.8 phosphate cradle. Aliquots of 0.5-5 ml were pipetted into 10 ml volumetric carafes from an answer with a convergence of 100 μg. The volume was adjusted with phosphate support 6.8 to get groups of expanding manner 5 to 50μg/mL.^11-13 The absorbance of each fixation was 215 nm.

Fabrication of Beads:

To optimise blank beads, preliminary tests were conducted with various amounts of sodium alginate and zinc sulphate. The concentrations that resulted in intact spherical beads were utilised to create drug-loaded beads. Drug containing poliglusam and sodium alginate: Tintiri mucilage beads were generated using ionotropic gelation. These solutions were created separately: Solution A: Using a magnetic stirrer, dissolve appropriately weighed sodium alginate, Tintiri mucilage, and medicine in 15 cc of distilled water for 30 minutes. Solution B: 35 ml deionised water dissolved in precisely weighed Zinc Sulphate. To this kind of arrangement, 10ml of Poliglusam solution with pH adjusted to 7±1 was added. After dumping solution A into solution B with a 22G syringe, the magnetic stirrer was turned on for fifteen minutes at 50 rpm. This resulted in ionotropic sodium alginate microbead gelation. Sodium alginate curing required 30 minutes of stirring. Following filtering using Whatman filter paper, the beads were rinsed with clean water and dried at room temperature for 12 hours. Glutaraldehyde was used to cross-link the beads. The beads were equally placed in a petri plate and kept in desiccators with glutaraldehyde. The beads were treated with glutaraldehyde for four hours.^14-16

Evaluation Parameters:^17-21

Micromeritics Properties:

The micromeretic parameters of the produced microbeads, including Tap density, Bulk density, Hauser's ratio, Carr's index, and Angle of repose, were assessed.

Table 1: Chart for Preparing Hydroxyzine HCl Microbeads

Batch	Drug (mg)	Sodium Alginate (%w/v)	Tintiri Mucilage (%w/v)	Zinc Sulphate (%w/v)	Sodium alginate and Tintiri Mucilage (%w/v)	Poliglusam (%w/v)	Glutaraldehyde (%w/v)
B1	100	4	4	15	-	-	-
B2	100	2	6	15	-	-	-
B3	100	6	2	15	-	-	-
B4	100	6	4	20	-	-	-
B5	100	2	4	20	-	-	-
B6	100	6	6	15	-	-	-
B7	100	4	6	10	-	-	-
B8	100	2	4	10	-	-	-
B9	100	6	4	10	-	-	-
B10	100	2	2	15	-	-	-
B11	100	4	6	20	-	-	-
B12	100	4	2	20	-	-	-
B13	100	4	2	10	-	-	-
B14	100	-	-	-	4:4	4	10
B15	100	-	-	-	2:6	6	10
B16	100	-	-	-	6:2	2	10
B17	100	-	-	-	6:2	4	12.5
B18	100	-	-	-	2:6	4	12.5
B19	100	-	-	-	6:2	6	10
B20	100	-	-	-	4:4	6	7.5
B21	100	-	-	-	2:6	4	7.5
B22	100	-	-	-	6:2	4	7.5
B23	100	-	-	-	2:6	2	10
B24	100	-	-	-	4:4	6	12.5
B25	100	-	-	-	4:4	2	12.5
B26	100	-	-	-	4:4	2	7.5

Tap Density:

The prepared microbeads' taped density was calculated using the tapping technique. Each batch's precisely weighed amount of microbeads was transferred to a 10-milliliter measuring cylinder. After determining the volume of microballoons in existence, tapping was performed on a hard surface until the volume did not gradually alter. At this moment, the tapped density was calculated.

Mass of microbeads

Tap Density: -------------------------------------

Volume of microbeads after tapping

Bulk Density:

It measures the relationship between powder mass and bulk volume. Pouring 2 g of manufactured microbeads into a clean measuring cylinder and measuring the starting volume yielded an estimated bulk density. This equation estimated the bulk density:

Mass of microbeads in gram

Bulk Density: -------------------------------------------

Volume of microbeads in cm³

Carr’s Index:

Calculating the Carr's index of the powder allows you to immediately determine the potential strength and stability of the powder arch or bridge. To determine it, the following formula is used:

Tap Density – Bulk Density

Carr’s Index: ---------------------------------------- x 100

Tap Density

Hauser’s Ratio:

It's known as the indirect indication of easy powder flow. This is an associate's degree. To determine it, the subsequent formula is used:

Tap Density

Hauser’s Ratio: ---------------------

Bulk Density

Angle of Repose:

In many circumstances, determining the point of rest is the approach utilised to evaluate the stream properties of floating microbeads. The resting point of microbeads was determined using the right channel approach and a good pipe on a burette stand. The microbeads were allowed to fall freely via the descent pipe until the apex of the cone-shaped heap, which had recently been formed, came into touch with the channel tip. The point of rest (θ) was calculated using the following equation:

Height of Pile

Tan θ =---------------------------------

Radius of Pile

Drug Entrapment Efficiency:

Beads that had been precisely measured to weigh ten milligrammes were placed in a container containing ten millilitres of phosphate cushion with a pH of 6.8. The mix was then passed around to signify 24 hours. The things in the measuring utensil were fomented for one to two hours with an appealing stirrer to completely break down the globules. From that moment forward, the beads were separated using channel paper. A bright visible spectrophotometer was used to measure the absorbance at 215 nm to determine how much medication (x) was present in a single bunch of beads before it was filtered through. To determine the adequacy of medication capture, the following equations were used:

% Medicament Entrapment efficiency= ---------- x 100

Where, AD = Genuine amount of medication present in Beadsand

DT = Hypothetical amount of medication added during readiness

Swelling Index:

Following the careful placement of Beads of every readiness in a recepticle containing 10 millilitres of phosphate cradle with a pH of 7.4 and 0.1N hydrochloric acid, the blend was allowed to sit at room temperature for six hours. The surplus fluid that had attached to the outer layer of the Beads was removed by wiping with channel paper, and the expanded Beadswere weighed with a load of seventeen. Each trial yielded three different groupings of findings. By applying the following equation, we have the opportunity to pick the growing record of the beads:

SB-DB

SI= ---------------

Were, SB= weight of enlarged Beads

DB= weight of dried Beads

Percentage Yield:

Weighing the microbeads after they had dried allowed us to determine the percentage yield of the microbead mixture that had been developed. The true load of the microbeads was separated by the absolute weight of the variety of non-unstable pieces that were employed in the assembly of the microbeads, and the outcome was resolved using the formula that is presented below.²²:

Genuine Weight of microbeads

Percentage Yield = -------------------------------- x 100

Hypothetical Weight of microbeads

Bead Size Determination:

The size of the alginate Beads was determined using an optical magnifying tool and a compound magnifying device. The optical micrometre was aligned using a normal stage micrometer.

Loose surface crystal study (LSC):

This study was done with the purpose of determining the quantity of medication detected on the outer layer of the microbeads, which demonstrated fast delivery when placed in dissolving solution. To recreate the dissolving media, 100 milligrammes of microbeads were suspended in 100 millilitres of phosphate support at a pH of 7.4. The samples were vigorously agitated in a mechanical shaker for fifteen minutes. The amount of drug that has filtered off the surface was determined by doing a spectrophotometric test at 215nm.²³

Surface Morphology:

The surface morphology of the produced microbeads was determined using the filtering electron microscopy (SEM) approach. To prepare the examples for electron microscopy (SEM), the microbeads were dispersed on a stub with two layers of adhesive tape. As a result, the stubs were coated with platinum while exposed to an argon atmosphere. This was accomplished by incorporating a gold falter module into an ultra high vacuum evaporator.^24-26

In vitro drug release:

The in-vitro arrival of supplied beads was investigated using 900 millilitres of 0.1 N hydrochloric corrosive with a pH of 1.2. The test was performed in 0.1 N hydrochloric acid for two hours, followed by the use of phosphate cradle for the excess span (pH 7.4). The device employed was USP-XXII, which rotated at a rate of 100 cycles per moment. Temperature was maintained at 37±5°C for up to 12 hours. During each time span, five millilitres of the example were taken out with the end objective of the research, and five millilitres of new dissolving medium were introduced all at once to retain the sink condition.^27-29. After the instances were removed, they were appropriately weakened, and the absorbance was measured using spectrophotometry at a frequency of 215nm.

Kinetics Study:

The medication discharge data was fitted to three different models: zero request (combined level of medication discharge versus time), first request (log of aggregate level of medication held versus time), and Higuchi models (combined level of medication delivered versus square foundation of time). Furthermore, the Korsmeyer-Peppas model (log level of aggregate medication discharge vs log of time) was used to sort out the energy of medication delivery to separate out the delivery component of the medicine from the organised drifting microbeads of Hydroxyzine HCl.^30-31.

Stability Study:

The purpose of security evaluation is to test anything and provide confirmation on how the nature of a restorative item or pharmaceutical fixing changes over time as a result of various environmental circumstances such as temperature, light, and stickiness. Furthermore, solidity testing serves as the foundation for recommended stockpile conditions, re-tests, and usability time spans. For this examination, solidness tests were conducted at room temperature (20 degrees Celsius ±2 degrees Celsius/60% relative stickiness ±5% relative mugginess) and accelerated testing (40 degrees Celsius ±2 degrees Celsius/75% relative moistness ±5% relative dampness) over 90 days to improve detailing. The improved detailing was analysed for both the amount of pharmaceutical discharge and the level of medication content.^32-34

RESULTS AND DISCUSSION:

Standard Calibration Curve:

The standard calibration curve for Hydroxyzine Hcl was found to be consistent with Beers Lambert's law. This was shown by the fact that the equation obtained was linear, with an R2 value of 0.9972. The equation found was 0.0446x-0.0375.

Figure 1: Standard Adjustment Bend of Hydroxyzine HCl

Micromeretic Study:

The micromeretics analysis revealed that the formulations had a higher flow property than the drug, with an angle of repose of 49.28o±0.25 for pure drug and 27.57^o±0.74 for the produced beads.

Table 2: Micrometric Properties of PE and Streamlined detailing

Sample

Tap Density (gm/cm³)

Bulk Density (gm/cm³)

Com-pressibility Index

Hauser’s Ratio

Flow Property

0.591±

0.72

0.389±

0.04

34.08

1.52

49.28⁰±

0.25

B20

0.785±

0.28

0.656±

0.14

16.47

1.20

27.57⁰±

0.74

Evaluation Parameters:

To develop the assessment parameters, numerous elements were investigated, including the percentage yield, swelling index, and drug entrapment efficacy of the produced beads. The study found that the beads had the highest drug entrapment efficacy (92.68±0.82%) compared to other formulations. Additionally, the yield was found to be 82.24±0.08 percent. The microbeads were developed with varying particle sizes. This might be due to human mistake. The microbeads were found to have particle sizes ranging from 1.017 to 1.214 millimetres. Based on the results of the loose surface crystal examination, it was discovered that the drug concentration on the surface of the produced microbeads ranged between 1.52 and 4.1%. Furthermore, the swelling index in both media was found to be between 180 and 200 in 0.1N hydrochloric acid and 170 to 1760 in buffer liquid with a pH of 7.4.

Surface morphology:

The surface morphology was investigated to determine if the microbeads were smooth or rough. The results of the surface morphology investigation revealed that the beads that were manufactured had a circular form, but the outside surfaces were rough and covered with an organisation of minute fractures and gaps.

Figure 2: a) Surface Morphology at 100magnification b) Surface Morphology at 10K

Magnification:

Medicament Drug Release:

The drug release from created microbeads lasted 12 hours. B1-B13 formulations released 0.87-98.34% of the medicine, whereas batches B14-B26 released 0.156-99.02%. This study also discovered that some formulations released the drug before the required time (8-10hours), which might be due to polymer concentration and ratios. The medicine release study also discovered that polymer and cross-liner concentrations are critical for drug release from any formulation. The optimum formulation was B20, which released the most medicine.

Kinetics Study:

An energy analysis was used to guide the integration of enhanced details onto several models. The review's findings revealed that the pharmaceutical discharge from the pre-arranged Beads had zero request energy, and that, because the value of "n" was less than 0.5, the medication discharge process followed super case II vehicle with fickian dispersion.

Figure 3: Percent Cumulative Drug Release of Beads for Formulations B1-B13

Figure 4: Percent Cumulative Drug Release of Beads for Formulations B14-B26

Table 3: Model Fitting Data for drug releases kinetics of beads.

Formulation	Zero Order	Rate Constant ‘K’	Korsmeyers Peppas	Value of ‘n’
B20	0.923	8.890	0.957	0.491

Stability Study:

The cumulative drug release and percentage drug content of the revised formulation were both within the optimum range and closely matched the results of the previous preparation. Based on the dependability research findings, it was determined that the superior plan remained stable throughout the evaluation period and showed no significant alterations.

CONCLUSION:

The microbead design aimed to reduce patient measurements recurrence and provide longer prescription delivery. FT-IR and DSC studies were used to evaluate unadulterated medication and identify any manufacturing-related differences. Results showed no contradiction between the medication and the polymers used, and the delivered beads had high flowability. Surface morphology revealed a rough surface with surface breaks. In-vitro examination revealed that polymer fixation or improper focus affects drug discharge. B20 was found to have the highest drug discharge over a 12-hour time frame, making it the ideal plan. Soluble media further improved prescription delivery. Glutaraldehyde was found to be the best cross-connecting specialist for the beads' rigidization. The medication discharge strategy followed zero order energy with super case II drug release.

CONFLICTS OF INTEREST:

None.

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Received on 20.09.2024 Revised on 10.12.2024

Accepted on 15.02.2025 Published on 03.05.2025

Available online from May 05, 2025

Asian J. Pharm. Res. 2025; 15(2):127-133.

DOI: 10.52711/2231-5691.2025.00021

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Room Temperature	% Drug Content	% Drug Release (After 12hrs)	Accelerated Study (40°C±2^oC/ 75 % RH ± 5% RH)	% Drug Content	% Drug Release (After 12hrs)
Day 0	92.68±0.82	99.02	Day 0	92.68±0.82	99.02
Day 15	92.68±0.82	99.02	Day 15	92.68±0.82	99.00
Day 30	92.68±1.73	98.89	Day 30	92.61±1.73	98.87
Day 45	92.51±0.24	98.88	Day 45	92.61±1.81	98.87
Day 60	92.50±1.38	98.88	Day 60	92.40±0.86	98.61
Day 90	92.50±0.74	98.87	Day 90	92.40±0.21	98.59