Nanosuspension Formulation Research Articles

Enhancing Herbal Efficacy: Synthesis and Evaluation of Nanosuspension from Withania somnifera Root Extract

Background: Ayurveda emphasizes the balance of mind, body, and spirit, drawing on ancient texts that highlight the medicinal properties of herbs like Withania somnifera, known for its wide range of therapeutic applications and pharmacological benefits. Commonly referred to as Indian ginseng or Ashwagandha, Withania somnifera, demonstrates a variety of therapeutic effect , including anti-inflammatory, antitumor, sedative, hypnotic, deobstruent effects, narcotic, antioxidant, tonic, antistress, diuretic, aphrodisiac, immunomodulatory, and rejuvenating properties. Nanotechnology, particularly through the development of nanosuspensions, offers a significant advancement in medicine, addressing challenges like poor solubility and low bioavailability of lipophilic drugs. Nanosuspensions can enhance drug safety and efficacy by improving solubility and altering pharmacokinetics. Methods: This study focuses on formulating and characterizing a nanosuspension using an ethanolic extract of Withania somnifera roots. The nanosuspension (NSWS) underwent comprehensive characterization, utilizing techniques such as FT-IR spectroscopy, particle size analysis, zeta potential measurement, polydispersity index (PDI) assessment, Field emission scanning electron microscopy (FESEM), X-ray diffraction analysis, pH measurement, and stability testing. This study seeks to explore the potential of nanosuspensions, aiming to integrate nanotechnology with herbal medicine to improve the safety and efficacy of herbal formulations. Results: The nanosuspension (NSWS) shown particle size about 133.09 nm, and its uniform particle distribution was indicated by a Polydispersity Index (PDI) about 0.27. Stability and uniformity were further supported by the zeta potential, particle size, and PDI values. Conclusion: Nanosuspension formulations represents a versatile strategy to improve the therapeutic efficacy of hydrophobic drugs across various routes of administration. Keywords: Withania somnifera, Nanosuspension, Characterization, FT-IR, PDI, FESEM

Formulation and Evaluation of Nano Suspension Based Oro Disoersible Film of Aripiprazole

The present study was aimed to enhance the solubility and dissolution of BCS class 4 drug aripiprazole, by nano formulation approach. Acid-base neutralization method had been used to produced nanosuspension. The nanosuspensions remained stable without any aggregations with particle size 209.6nm and PDI 0.247. Zeta potential was found to be 3.5mV. Drug content, Entrapment and solubility of nanosuspension formulations were determined. In vitro drug release of the selected formulation has shown a drug release of 95.63% by the end of 1 hr, whereas plain drug suspension has shown only 12.3% release. XRD and DSC studies revealed that the solid form of aripiprazole altered from the crystalline state to the amorphous state after incorporation into nanosuspensions. Hence, from the results, it can be concluded that Aripiprazole, when formulated by acid-base neutralization method as a nanosuspension, leads to enhanced solubility, dissolution, and stability

Key Challenges, Influencing Factors, and Future Perspectives of Nanosuspensions in Enhancing Brain Drug Delivery.

Many brain diseases pose serious challenges to human life. Alzheimer's Disease (AD) and Parkinson's Disease (PD) are common neurodegenerative diseases that seriously threaten human health. Glioma is a common malignant tumor. However, drugs cannot cross physiological and pathological barriers and most therapeutic drugs cannot enter the brain because of the presence of the Blood-brain Barrier (BBB) and Bloodbrain Tumor Barrier (BBTB). How to enable drugs to penetrate the BBB to enter the brain, reduce systemic toxicity, and penetrate BBTB to exert therapeutic effects has become a challenge. Nanosuspension can successfully formulate drugs that are difficult to dissolve in water and oil by using surfactants as stabilizers, which is suitable for the brain target delivery of class II and IV drugs in the Biopharmaceutical Classification System (BCS). In nanosuspension drug delivery systems, the physical properties of nanostructures have a great impact on the accumulation of drugs at the target site, such as the brain. Optimizing the physical parameters of the nanosuspension can improve the efficiency of brain drug delivery and disease treatment. Therefore, the key challenges, influencing factors, and future perspectives of nanosuspension in enhancing brain drug delivery are summarized and reviewed here. This article aims to provide a better understanding of nanosuspension formulation technology used for brain delivery and strategies used to overcome various physiological barriers.

Study of sertraline solubility, solvent effect, and modeling in the aqueous mixtures of dimethyl sulfoxide or diethylene glycol monoethyl ether at several temperatures and its use in the formulation of nanosuspensions

The solubility profile of a weakly water-soluble drug of sertraline (SRT) at the temperature range of 298.2–318.2 K under atmospheric pressure, in the binary aqueous mixtures of dimethyl sulfoxide (DMSO) and diethylene glycol monoethyl ether (DEGMEE) was measured using a shake-flask method. As a result, SRT was discovered to have the maximum solubility in DMSO among investigated solvent systems. The obtained solubility values were correlated by utilizing cosolvency models, including the Jouyban-Acree-van't Hoff and Jouyban-Acree models, and the mean relative deviations were computed in order to evaluate the precision of these equations. Additionally, using the van't Hoff and Gibbs formulas at Thm, the parameters of apparent thermodynamics (Gibbs energy, entropy, and enthalpy) of SRT in the saturated mixtures were calculated. According to these solubility results, SRT nanosuspensions, which had a mean particle size of under 200 nm, were formulated in DMSO and water as a solvent combination. Therapeutic development could be significantly improved by implementing solubilization strategies for enhancing the bioavailability of medicines that are only weakly water-soluble, according to the results of the experimental and statistical assessment of solubility.

Development of a screening platform for the formulation of poorly water-soluble drugs as albumin-stabilized nanosuspensions using nab™ technology

The nanoparticle albumin bound™ (nab™) technology generally offers great potential for the formulation of poorly water-soluble drugs as albumin-stabilized nanosuspensions for intravenous use while avoiding solubilizers and cross-linking agents. The nab™ technology is a three-step process consisting of emulsification, high-pressure homogenization and solvent evaporation.Within this work, a screening approach was developed to predict whether active pharmaceutical ingredients are suitable for nab™ formulations. A design of experiments approach was used to investigate the effects of ultrasonic homogenization on an albumin-stabilized itraconazole nanosuspension. Based on this, a screening platform was developed, and subsequently evaluated and applied to a selection of poorly water-soluble drugs. The screening process to produce albumin-stabilized nanosuspensions consists of two process steps: Ultrasonic treatment, which combined emulsification and homogenization, followed by solvent evaporation. The results of the screening process were fully transferable to the standard three-step process of nab™ technology. In addition, based on drug screening, drug properties were highlighted that are important for the development of nab™ formulations.All in all, the nab™ technology is a promising but not universal formulation platform for poorly water-soluble drugs. Nevertheless, for some poorly soluble drugs it offers a valuable approach for the formulation of nanosuspensions for intravenous use.

Formulation and Evaluation of Nanosuspension of Mebendazole for Solubility Enhancement by High Pressure Homogenization Technique

Background: Developing and evaluating a drug taken by mouth delivery method with mebendazole nanosuspension to treat intestinal worms infestations are the main objectives of the current research effort. This is because drug particles in the nano range help to reduce particle size and enhance dissolution. Methods: By using High pressure homogenization method, the mebendazole is converted into nanosuspension. Various amounts of HPMC K4M used as a stabilizer and Tween 80 and Poloxamer 188 used as a surfactant and compare its ratios. The results were investigated using effectiveness of drug entrapment, saturation solubility, zeta potential, particle size, drug release study and stability testing. Result: The drug purification results are shown by knowing the FT-IR spectrum. With a good entrapment efficiency and saturated solubility, optimized batches are found and the use of transmission electron microscopy confirms the nano size particle formed. The mebendazole nanosuspension showed higher release in the target site within 12 hours, according to an in-vitro dissolution experiment. Using the oral route for administration of the mebendazole nanosuspension, it increases the drugs absorption along with complete drug releasing. Conclusion: The study indicates that the prepared mebendazole nanosuspension has increased the rate of dissolution and solubility by converting nano range particles and encouraging the use of BCS class Ⅱ drugs with acceptable stability.

Effect of Lyophilization on Characteristics of Iloperidone Nanosuspension

Objective: The primary objective of this study is to develop the nanosuspension formulation of iloperidone and to check the effect of lyophilization on different characteristics of iloperidone nanosuspension.Methods: Solvent-antisolvent method with probe ultrasonication was used for the formulation of nanosuspension. The nanosuspension was then converted into lyophilized form by using mannitol as a cryoprotectant and then evaluated for various parameters, including particle size, saturation solubility, scanning electron microscopy (SEM), thermal analysis, fourier-transform infrared (FTIR), in-vitro drug release study. Result: From the study it was observed the increase in concentration of cryoprotectant while lyophilization has increased the particle size of nanosuspension. As there was an increase in particle size after lyophilization, there was a decrease in saturation solubility. In-vitro drug release also indicates a slight decrease in drug release after lyophilization. Overall, lyophilization might be used in the improvement of stability of nanosuspension, parameters must be chosen carefully for the process of lyophilization in order to obtain nanosuspension with good characteristics.

Nanosuspension Formula of Curcuma xanthorriza Rhizome Dry Extract: Impact of Tween 80-PEG 400 Ratio

Our previous research investigated nanosuspension using the ionic gelation method with a 2:1 ratio of chitosan to sodium tripolyphosphate (TPP) and 0.44% Curcuma xanthorriza rhizome extract. The results indicated an unstable nanosuspension with a particle size of 399.3 nm, a polydispersity index of 0.60, and an entrapment efficiency of 73.37%. This study aims to develop a nanosuspension using Tween 80-PEG 400 to improve the characteristics and dissolution at pH 6.8. Curcuma rhizome was macerated with 96% ethanol and dried using a spray dryer. The nanosuspension formulation was designed using a 22 factorial design with Tween 80 (0.1%-0.4%) and PEG 400 (0.1%-0.4%) as factors, and the formulation was analyzed using Minitab 18. The dissolution of the optimum formulation was tested. The best formulation, comprising 0.1% Tween 80 and 0.4% PEG 400, provided a spherical shape, a particle size of 111.26 nm, a polydispersity index of 0.27, a zeta potential of 30.77 mV, an entrapment efficiency of 84.30%, and a desirability value of 0.9058. The release of curcumin at pH 6.8 after 180 minutes was 37.85% ± 0.1375 with a DE180 of 83.60% ± 0.1457. The 22 factorial design proved effective for enhancing formulation attributes. Based on the result obtained, it can be concluded that the best formulation contains 0.1% Tween 80 and 0.4% PEG 400, with zero-order release kinetics and a diffusion mechanism.

Formulation and evaluation of Fluconazole Nanosuspensions: In vitro characterization and transcorneal permeability studies

The aim in this study was to develop and evaluate a nanofluconazole (FLZ) formulation with increased solubility and permeation rate using nanosuspensions. The FLZ nanosuspensions were stabilized using a variety of stabilizing agents and surfactants in various concentrations. The FLZ nanosuspension was characterized in vitro using particle size, zeta potential, X-ray powder diffraction (XRPD), and solubility. In addition, the ex vivo ocular permeation of FLZ through a goat cornea was analyzed. The results showed that the particle size of all nanosuspension formulations was in the nanometer range from 174.5 ± 1.9 to 720.2 ± 4.77 nm; that of the untreated drug was 18.34 μm. The zeta potential values were acceptable, which indicated suitable stability for formulations. The solubility of the nanosuspensions was up to 5.7-fold higher compared with that of the untreated drug. The results of the ex vivo ocular diffusion of the FLZ nanosuspensions showed the percentage of FLZ penetrating via the goat cornea increased after using Kollicoat to stabilize the nanosuspension formulation. Consequently, when using a nanosuspension formulation of Kollicoat, the antifungal activity of the drug strengthens.

Formulation and Characterization of Clozapine Nanosuspension as a Sublingual Film

Background: Clozapine (CLZ) is a potent antipsychotic drug that suppresses the symptoms of schizophrenia and mania. Clozapine falls into Class II (BCS); its poor bioavailability is attributed to low water solubility and an extensive first-pass effect. Objective: To prepare CLZ as a nanosuspension (NS) to improve its low water solubility and load it into a sublingual film to enhance oral bioavailability. Methods: CLZ nanosuspensions are prepared by the “solvent anti-solvent precipitation” method using Soluplus as a stabilizing agent. We evaluated the polydispersity index (PDI) and the particle size of the CLZ nanosuspension formulations. The optimized formula of CLZ nanosuspension is loaded directly onto a sublingual thin film, eliminating the need for freeze-drying for solidification by the solvent casting approach. The sublingual films were characterized by thickness, surface pH, folding endurance, disintegration time, and in vitro dissolution rate. Results: We selected the formula F1 sublingual film as the best, as it demonstrated a uniform thickness of 0.087mm, good flexibility, and a surface pH of 6.7. It disintegrated quickly in 13 seconds and had a faster in vitro dissolution rate (3 min) compared to the CLZ ordinary films. Conclusions: The results confirmed the success of CLZ NS as a sublingual thin film for dissolution rate enhancement, which may improve oral bioavailability.

Locally administered nanosuspension increases delivery of estradiol for the treatment of vaginal atrophy in mice.

Vaginal atrophy affects up to 57% of post-menopausal women, with symptoms ranging from vaginal burning to dysuria. Estradiol hormone replacement therapy may be prescribed to alleviate these symptoms, though many vaginal products have drawbacks including increased discharge and local tissue toxicity due to their hypertonic nature. Here, we describe the development and characterization of a Pluronic F127-coated estradiol nanosuspension (NS) formulation for improved vaginal estradiol delivery. We compare the pharmacokinetics to the clinical comparator vaginal cream (Estrace) and demonstrate increased delivery of estradiol to the vaginal tissue. We utilized ovariectomized (OVX) mice as a murine model of post-menopausal vaginal atrophy and demonstrated equivalent efficacy in vaginal re-epithelialization when dosed with either the estradiol NS or Estrace cream. Further, we demonstrate compatibility of the estradiol NS with vaginal bacteria in vitro. We demonstrate that a Pluronic F127-coated estradiol NS may be a viable option for the treatment of post-menopausal vaginal atrophy.

DEVELOPMENT AND OPTIMIZATION OF A DOLUTEGRAVIR NANOSUSPENSION USING BOX BEHNKEN DESIGN

Objective: This study aimed to develop and optimize a nanosuspension of Dolutegravir, an integrase inhibitor with low aqueous solubility, using the sonoprecipitation technique. The objective was to enhance the drug's solubility and oral bioavailability by preparing nanosuspension. Methods: A box-behnken design was employed to systematically investigate the impact of stabilizer concentration, sonication amplitude, and time on the particle size and polydispersibility of the nanosuspension formulations. Various stabilizers, including Soluplus®, Poloxamer 188, Poly Vinyl Pyrrolidone (PVP) K90, Hydroxy Propyl Methyl Cellulose (HPMC), and Tween 80, were evaluated. Fourier transform infrared spectroscopy confirmed drug-polymer interactions, while differential scanning calorimetry and X-ray diffraction revealed partial amorphization. Scanning electron microscopy confirmed nanoscale particle size and morphology. Results: The optimized formulation (NS6) with 1% Soluplus®, 65 W amplitude, and 10 min sonication exhibited nanoparticles of 75.3 nm with low polydispersity. NS6 demonstrated enhanced drug release compared to the pure drug, attributed to particle size reduction and amorphization. In vitro tests indicated acceptable stability over time and temperature. Conclusion: The application of Box-Behnken design resulted in an optimized nanosuspension formulation capable of improving the oral bioavailability of poorly soluble Dolutegravir. The formulation exhibited favorable characteristics, including reduced particle size, amorphization, and enhanced drug release, highlighting its potential as an effective delivery system for Dolutegravir in Human Immuno Deficiency Virus (HIV) treatment.

Formulation and Evaluation of Ketoconazole Nano-suspension

The use of antifungals that are widely used by the public is ketoconazole. Ketoconazole is included in the Biopharmaceutical Classification System (BCS) II category, where the drug is poorly soluble in water but has high permeability. In this study, ketoconazole was prepared in a nanosuspension formulato increase solubility. The method for preparing 2% ketoconazole nanosuspension used a sonicator bath with variations of tween 80 (F1 8%, F2 10%, F3 12%) and transcutol as surfactant and co-surfactant. The results showed that the particle size of the ketoconazole nanosuspension F1 was 102 ± 4.3 nm, F2 was 105 ± 3.2 nm, and F3 was 90 ± 2.4 nm on day 0. Testing on day 28 showed an increase in particle size in F1 115 ± 3.1 nm, F2 129±4.5nm, F3 97±2.4nm (p>0.05). In testing the morphology of the nanosuspension using Scanning Electron Microscopy (SEM), The results showed that the irregular spheres were scattered. Organoleptic testing showed clear and homogeneous preparations. pH testing for 28 days showed a pH range of 5.6-6 which is included in the physiological skin pH range (p>0.50). Nanosuspension preparations can be said to meet the physical evaluation requirements.

Enhancement in Dissolution Profile of Cilnidipine by Nanonization Technique: Optimization by Box-Behnken design

Objectives: Cilnidipine has limited 25-30% of bioavailability due to BCS class II category drug. The aim of present work was to improve the solubility followed by dissolution rate of cilnidipine by formulation of nanosuspension. Materials and Methods: The nanosuspensionwas developed usingnanoprecipitation techniqueaidingultra-sonication with solvent (Dimethyl sulfoxide), antisolvent (water) and stabilizer (polyvinyl alcohol). The nano formulation was statistically optimized using Design Expert software by theBox-Behnken design. The concentration of Poly Vinyl Alcohol, Volume of Antisolvent and Stirring Time were considered as independent factors whereas Particle size and polydispersity index were considered as dependent factors. Results: The particle size of nanosuspension was found 178.57nm with narrow polydispersity index of 0.130. The microscopy study confirmed amorphous nature particles with rough surface. The zeta potential of 4.55 ±2.78 for optimized formulation finds stability of formulation during storage. The differential scanning calorimetry study and X-ray diffraction pattern showed the crystalline cilnidipine drug was converted to amorphous form upon precipitation into nanoparticles. Due to the nanonization of cilnidipine, the dissolution profile was noted as 92.41±3.56% which was significantly improved as compared with plain drug release data. The stability data showed satisfactory result for 2 months. Conclusion: It is summarized that the nanoprecipitation technique with ultra-sonication is approaching method for the formulation of homogenous nanosuspension with uniform sized dispersion of cilnidipine. Therefore, it can be assumed that the upon the enhancement in dissolution rate, the cilnidipine loaded nanosuspension may lead to improved absorption of drug from intestine followed by significant improvement in bioavailability.

Nano-titania and carbon nanotube-filled rubber seed oil as machining fluids

Machinists face persistent challenges in managing heat dissipation during cutting operations. To address this issue in an environmentally conscious manner, there is a need for nanofluids crafted from sustainable, eco-friendly materials. This study delves into developing nanocomposites (NCs) of nano-titania (nTiO2) derived from Terminalia catappa leaves and carbon nanotubes (CNTs) in varying compositions (nTiO2/CNTs: 90/10, 70/30, and 50/50 wt%). These NCs underwent comprehensive characterization using techniques such as BET, HRSEM/EDX, HRTEM, XRD, and FTIR. The aim was to evaluate their stability as potential fillers in rubber seed oils (RSOs) for machining operations. Furthermore, the homogenous NC samples in RSO revealed distinct polycentric rings, indicating the dispersion of nTiO2 in CNTs, forming Ti–O–C and Ti–O–Ti networks. XRD analysis identified anatase diffraction peaks, though the CNT peaks were less distinct due to overlap with TiO2 peaks. This successful fusion addresses challenges related to individual fillers, ensuring stable nanosuspension formulation. The TiO2/CNTs (50/50 wt%) NC emerged as particularly effective in dissipating heat from machining interfaces. The study highlights the nanomaterials' high thermal stability, complementing the abundant unsaturated fatty acids in RSOs to create advanced nanofluids for improved machining. The substantial pore volume and stable nanosuspension formation observed are attributed to the large surface area aiding heat removal. Ultimately, the reinforced RSO with nTiO2/CNTs shows promising potential for safe and efficient machining applications.

Comparison of the pharmacokinetic characteristics and bioequivalence between two nanosuspension formulations of megestrol acetate in healthy Korean male subjects.

ClinicalTrials.gov Identifier: NCT06147908.

Daidzein nanosuspension in combination with cisplatin to enhance therapeutic efficacy against A549 non-small lung cancer cells: an in vitro evaluation.

Lung cancer is the most common cause of cancer-related mortality, chemo-resistance, and toxicity limit treatment. The focus is on innovative combined phytotherapy to improve treatment outcomes. Our aim was to investigate the potential effects of daidzein nanosuspension (DZ-NS) and its combination with cisplatin (CIS) on A549 non-small lung cancer cells. Cytotoxicity was investigated using MTT and Chou-Talalay methods. Oxidative, apoptotic, and inflammatory markers were analyzed by ELISA and qRT-PCR. The IC50 value for DZ-NS was 25.23 µM for 24 h and was lower than pure DZ (IC50 = 835 µM for pure DZ). DZ-NS (at IC50x2 and IC50 values) showed synergistic cytotoxicity with CIS. The cells treated with DZ-NS had low TOS and OSI levels. However, DZ-NS failed to regulate Cas3 and TGF-β1 activation in A549 cells. MMP-9 gene expression was significantly suppressed in DZ-NS-treated cells, especially in combination therapy. DZ represents a potential combination option for the treatment of lung cancer, and its poor toxicokinetic properties limit its clinical use. To overcome these limitations, the effects of the nanosuspension formulation were tested. DZ-NS showed a cytotoxic effect on A549 cells and optimized the therapeutic effect of CIS. This in vitro synergistic effect was mediated by suppression of MMP-9 and not by oxidative stress or Cas3-activated apoptosis. This study provides the basis for an in vivo and clinical trial of DZ-NS with concurrent chemotherapy.

Formulation and Evaluation of Ledipasvir Nano-suspension Through QbD Approach

Ledipasvir, belonging to the BCS class II, is a directly acting anti-viral agent used to treat Hepatitis C virus infections. Due to poor water solubility and oral bioavailability, developing an effective delivery system for this drug has been an enormously challenging issue for the formulators. Moreover, suitable dosage forms for pediatric and geriatric patients and patients having difficulty in swallowing as well pose an added burden. Therefore, the present study aims to formulate a nanosuspension, via a solid dispersion technique, based on liquid oral suspension using the Quality by Design (QbD) method. Primarily, the compatible polymers for Ledipasvir were screened using FT-IR and DSC, and finally, the polymers- poloxamer 188, poloxamer 407, HPC and HMPC were selected, considering their ability to turn the API into amorphous state in solid dispersions. The design of formulation and analysis with the D-Optimal design using Design Expert® Software revealed that poloxamer 188 and poloxamer 407 at 0.3:0.7 ratio of Ledipasvir:Polymer produced the optimized nanosuspension formulations with a statistically significant mathematical model. Subsequently, the formulations were stabilized using a suspension vehicle optimized via Box-Behnken design using the amount of xanthan gum (gm), avicel® RC-591 (gm) and citric acid monohydrate (gm) as independent variables, and viscosity (cp) and zeta potential (mv) as responses. The dissolution profiles revealed that the prepared suspensions of Ledipasvir had much faster dissolution than the market products available as the tablet dosage form. In-vivo simulation studies using PKSolver® suggested that the absorption of the drug from the formulated suspensions was comparable to that of market product up to a single dose level (90 mg) and superseded in triplicate dose level (270 mg). The formulated suspensions were found to be stable over three- and six-month periods, as identified via accelerated stability studies. Interestingly, the dissolution profile of the stabilized suspensions was found to be similar after six months to that of the initial. Dhaka Univ. J. Pharm. Sci. 22(2): 173-188, 2023 (December)

Innovative Nanosuspension Formulation for Prochlorperazine and In-vitro Evaluation

Prochlorperazine is a dopamine antagonist and is used to control nausea and vomiting. It is a BCS class II drug which has low aqueous solubility and high permeability. The present study is aimed to formulate and evaluate prochlorperazine nanosuspension to improve solubility and enhance dissolution of Prochlorperazine with varying concentrations of stabilizers such as Tween 80, PVP K30, Poloxamer 188 by using nanoprecipitation method. The developed formulations were characterized for particle size and polydispersity index, total drug content, SEM, Zeta Potential and FTIR. The invitro drug release studies and invitro drug release kinetics were performed for all formulations. FTIR studies revealed that drug is compatible with the excipients. The particle size and poly dispersity index of optimized formulation was found to be 162nm and the zeta potential was found to be -30.2 mV and concluded that the system had sufficient stability. The invitro drug release was found within their acceptable ranges. The rate of dissolution of best batch was enhanced to 93.24 in 120min. Stability studies proved that nanosuspensions were more stable with no significant changes in particle size distribution. Thus the formulated nanosuspension of prochlorperazine offers a superior conventional dosage forms for drug release
 Keywords: Prochlorperazine, Nanosuspension, Solubility, Dissolution

"Optimizing Pharmaceutical Formulations: Advancements in Nanosuspension Pre-Formulation to Enhance Solubility and Bioavailability of Active Agents"

This study aimed to enhance the bioavailability of a poorly water soluble drug by developing a nanosuspension through an innovative formulation method. The nanosuspension was produced with meticulous attention to the materials reliability and excellent quality. Nepafenac was characterised in the pre-formulation study by establishing its melting point, solubility in different solvents, organoleptic properties, and creating a calibration curve. We utilised UV spectroscopy to determine the maximum wavelength (?max) of Nepafenac and construct a standard calibration curve in ethanol. To ensure the compatibility of the medicine with the polymers (Pluronic F127 and HPMC E 5), Fourier Transform Infrared Spectroscopy (FTIR) was utilised for drug interaction analysis. The nanosuspension was produced using the solvent diffusion approach. The effect of different concentrations of Poloxamer 407 and HPMC E 5 on the formulation's effectiveness was investigated experimentally using a 32 complete factorial design. We used Response Surface Methodology (RSM) and statistical analysis to enhance the formulation concerning in vitro release, particle size, and viscosity. The pre-formulation characteristics of Nepafenac met the standards outlined in the Pharmacopoeial regulations. The maximum absorption wavelength (?max) of Nepafenac was confirmed by UV spectroscopy, and a reliable calibration curve was created. The FTIR analysis showed no chemical interaction between the medicine and polymers. RSM and experimental design indicated that Poloxamer 407 and HPMC E 5 had a substantial impact on the performance of the nanosuspension. Analysis of variance (ANOVA) confirmed the model and parameters that influence controlled drug release percentage, particle size, and viscosity. Optimal conditions for enhancing drug delivery and reducing particle size were determined by the analysis of contour and response surface plots. The optimal parameter values, as indicated in the desirability plots, closely matched the anticipated values. The experimentation confirmed the viability and effectiveness of the nanosuspension formulation generated based on the RSM findings.