Formulation Excipients Research Articles

Utilization of pectin as a polysaccharide microcarrier for drug delivery

Pectin is a polysaccharide of natural origin, which has been widely exploited in the food and pharmaceutical industry due to its biodegradable and biocompatible nature. It is commonly used as an efficient texturizer and stabilizer in different food products due to its high stability and also as a pharmaceutical excipient in various drug formulations due to its valuable characteristics. The utilization of pectin as a drug carrier for achieving controlled drug release in pharmaceutical dosage forms has been extensively researched recently. Pectin has the potential for targeted drug delivery due to its degradation by colonic microorganisms, making it a popular subject of investigation for biomedical applications. The developed in recent years pectin microparticle systems have several advantages over classical pectin gel formulations. These advantages include higher drug loading efficiency, reduced burst drug release, and the ability to better control the drug release and limit the polymer swelling. This review outlines the recent developments of pectin as a microcarrier in the production of drug delivery systems, which include the properties of the polysaccharide material essential for microparticle production, specific formulation methods with their key technological parameters, influencing the final microparticle product and potential applications of the proposed pectin microsized formulations.

Revolutionizing Drug Formulation: Harnessing Artificial Intelligence and Machine Learning for Enhanced Stability, Formulation Optimization, and Accelerated Development

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in the field of pharmaceutical drug formulation has sparked a paradigm shift in the way drug stability is predicted, formulations are optimized, and drug development is expedited. This review delves into the transformative impact of AI and ML techniques on pharmaceutical research and development. It highlights how predictive models driven by AI algorithms are effectively simulating drug degradation pathways and stability profiles, enabling scientists to make informed decisions during formulation design. Moreover, the utilization of ML algorithms to analyze vast datasets has led to the discovery of optimal formulations by identifying critical relationships between formulation variables, excipients, and drug properties. This approach not only reduces experimentation time and costs but also enhances the likelihood of developing robust and effective drug products. Furthermore, AI-powered drug development platforms are shortening the timeline for candidate selection, preclinical evaluations, and clinical trials, thereby accelerating the entire drug development process. This article explores the evolving landscape of AI and ML in drug formulation, discusses challenges, and anticipates future prospects in this transformative field.

Development of Relatively Simple Sample Pretreatment Strategies to Selectively Remove Chromatographic Interfering Peaks of Polysorbate 80 from Liquid Oral Finished Drug Product.

Polysorbate 80 (PS 80) is a nonionic surfactant, used in myriad of pharmaceutical, food and cosmetic formulations. PS 80 components have strong UV absorbance and retain under reversed-phase chromatographic conditions, significantly masking sections of the chromatogram. PS 80-related peaks interferences in a sample are common and can be difficult to separate from the analyte peaks. A liquid oral finished product (LOFP) containing PS 80 and Ivermectin as the active pharmaceutical ingredient (API) was selected for this study. Herein, we report two sample pretreatment strategies focusing on the selective removal of PS 80 from the LOFP. Both methods significantly reduce and/or practically eliminate excipients and PS 80-related peaks interferences from the LOFP without a negative impact on the API and its key-related substances recovery. The solid-phase extraction (SPE) strategy uses a C18 SPE followed by a silica gel SPE, whereas the liquid-liquid extraction strategy uses in situ-generated sodium caprylate for the removal of formulation excipients and PS 80. These methods can significantly increase the reliability of high-performance liquid chromatography methods and decrease false positive out-of-specifications events because of coelution of PS 80-related peaks with peaks of interest.

Insulin Tregopil: An Ultra-Fast Oral Recombinant Human Insulin Analog: Preclinical and Clinical Development in Diabetes Mellitus.

Insulin therapy is indispensable for achieving glycemic control in all patients with type 1 diabetes mellitus and manypatients with type 2 diabetes mellitus. Insulin injections are associated with negative connotations in patients owing to administration discomfort and adverse effects such as hypoglycemia and weight gain. Insulin administered orally can overcome these limitations by providing a convenient and effective mode of delivery with a potentially lower risk of hypoglycemia. Oral insulin mimics the physiologic process of insulin secretion, absorption into the portal circulation, and subsequent peripheral delivery, unlike the subcutaneous route that results in peripheral hyperinsulinemia. Insulin tregopil (IN-105), a new generation human recombinant insulin, methoxy (polyethylene glycol) hexanoyl human recombinant insulin, is developed by Biocon as an ultra-fast onset short-acting oral insulin analog. This recombinant oral insulin is a single short-chain amphiphilic oligomer modified with the covalent attachment of methoxy-triethylene-glycol-propionyl moiety at Lys-β29-amino group of the B-chain via an amide linkage. Sodium caprate, an excipient in the insulin tregopil formulation, is a permeation enhancer that increases its absorption through the gastrointestinal tract. Also, meal composition has been shown to non-significantly affect its absorption. Several global randomized, controlled clinical trials have been conducted in type 1 and type 2 diabetes patients towards the clinical development of insulin tregopil. The formulation shows post-prandial glucose control that ismore effective than placebo throughout the meal period; however, compared withan active comparator insulin aspart, the post-prandial control ismore effective mainly in the early post-meal period. It shows a good safety profile with a lower incidence of clinically significant hypoglycemia. This review covers the overall clinical development of insulin tregopil establishing it as an ultra-fast onset, short-acting oral insulin analog for optimizing post-prandial glucose.

Drug-excipient compatibility studies in formulation development: A case study with benznidazole and monoglycerides

Monoglycerides (MGs) such as glycerol monolaurate (GML) and glycerol monostearate (GMS) have been used as excipients in oral formulations because of their emulsifying effect as well as their ability to inhibit the precipitation and intestinal efflux of drugs. Excipient-drug compatibility studies, however, have been underexplored. In this study, benznidazole (BNZ) was selected as a drug model due to the difficulty in improving its solubility and because of the potential impact on public health (it is the only drug currently used to treat Chagas disease). The effect of different processing conditions (maceration, ball milling, and melting) on the physical-chemistry properties of BNZ/MGs mixtures was investigated to guide the rational development of new solid formulations. GML was more effective in improving the solubility of BNZ, which could be due to its more malleable structure, less hydrophobic nature, and greater interaction with BNZ. The formation of hydrogen bonds between the imidazole group of BNZ and the polar region of GML was confirmed by spectroscopy analyses (IR, 1H NMR). The higher the monoglyceride content in the mixture, the higher the BNZ solubility. Regardless of the method of processing the mixture, the drug was found to be crystalline. Polarized light microscopy analysis showed the presence of spherulites. Overall, these findings suggest that preparation methods of BNZ:MGs formulations that involve thermal or/and mechanical treatment have a low impact on the solid properties of the material, and this allows for the production of formulations with reproducible performance.

Talc concentration effect on shelf life of acetaminophen tablets

Excipients in pharmaceutical formulations are inactive ingredient from the biological point of view, but they have a key role in the preparation, and they can alter the stability of the active principle. In this work, we prepared acetaminophen tablets with different amounts of talc as excipient and the thermal stability was deeply investigated by thermogravimetric studies. Isoconversional analysis by Kissinger–Akahira–Sunose method and “Master plot” analysis have been successfully employed to describe the kinetics of degradation under inert atmosphere, and the shelf lives have been calculated as a function of the talc content. The shelf-life values as well as the activation energy, which is the dominant factor, evidenced that the inorganic filler enhances the drug degradation to a certain extend and that the composition dependence has a peculiar trend reflecting the particle cluster formation at a critical concentration value. An effort of physico-chemical explanation for this behaviour is put forward by a simple geometrical model from the microparticle-size analysis to predict the critical talc concentration.

Application of Quality by Design Principles to the Development of Oral Lyophilizates Containing Olanzapine.

Oral lyophilizates are intended for application to the oral cavity or for dispersing in water. The purposes of this research were: (i) to set up the quality by design approach in the development of oral lyophilizates for drug incorporation; and (ii) to evaluate the established approach by comparing its outcomes with experimentally obtained results. Within the knowledge space, properties about drugs, excipients, and the lyophilization process were acquired, followed by the determination of critical quality attributes via risk identification. Risks were assessed by failure mode and effective analysis, which recognized critical material attributes, i.e., type, concentration, particle size, solubility of drug and excipients, while as main critical process parameters, cooling rate, shelf temperature, and chamber pressure during drying were pointed out. Additionally, design space was established using the Minitab® 17 software and valued with an 88.69% coefficient of determination. A detailed comparison between the model and experimental results revealed that the proposed optimal compositions match in the total concentration of excipients (6%, w/w) in the pre-lyophilized liquid formulation, among which mannitol predominates. On the other hand, a discrepancy regarding the presence of gelatin was detected. The conclusion was that the set model represents a suitable onset toward optimization of drug-based oral lyophilizates development, preventing unnecessary investment of time and resources.

X-ray Diffraction of Water in Polyvinylpyrrolidone.

PVP is a hydrophilic polymer commonly used as an excipient in pharmaceutical formulations. Here we have performed time-resolved high-energy X-ray scattering experiments on pellets of PVP at different humidity conditions for 1-2 days. A two-phase exponential decay in water sorption is found with a peak in the differential pair distribution function at 2.85 Å, which is attributed to the average (hydrogen bonded) carbonyl oxygen-water oxygen distance. Additional scattering measurements on powders with fixed compositions ranging from 2 to 12.3 wt % H2O were modeled with Empirical Potential Structure Refinement (EPSR). The models reveal approximately linear relations between the carbonyl oxygen-water oxygen coordination number (nOC-OW) and the water oxygen-water oxygen coordination number (nOW-OW) versus water content in PVP. A stronger preference for water-water hydrogen bonding over carbonyl-water bonding is found. At all the concentrations studied the majority of water molecules were found to be randomly isolated, but a wide distribution of coordination environments of water molecules is found within the PVP polymer strands at the highest concentrations. Overall, the EPSR models indicate a continuous evolution in structure versus water content with nOW-OW=1 occurring at ∼12 wt % H2O, i.e., the composition where, on average, each water molecule is surrounded by one other water molecule.

Abstracts from The Aerosol Society Drug Delivery to the Lungs 33.

Abstracts from The Aerosol Society Drug Delivery to the Lungs 33.

Solubility determination and thermodynamics modeling of n-alkyl-parabens in short-chain alcohols from (288.15 to 318.15) K

The well-established preservative and antimicrobial effect of alkyl parabens result in its wide application in the food, cosmetics, and pharmaceutical industries and motivates the solubility data obtaining. In this work, the solubility of parabens (methyl-, ethyl-, propyl-, and butyl-) in short-chain alcohols (ethanol, n-propanol, and 2-propanol) was experimentally determined by the gravimetric method from 288.15 to 318.15 K. Different thermodynamic models (Wilson, NRTL, UNIFAC; and COSMO-SAC models) were applied to correlate the experimental data. In general, the mole fraction of parabens increased with increasing temperature, following the order butyl > propyl > ethyl > methyl parabens in the three investigated solvents. Wilson and NRTL models presented a good correlation, according to the calculated values of mean squared deviation (RMSD) and absolute deviation (AD), while the UNIFAC showed high deviations, which was expected because it is not an adjustable model. The COSMO-SAC model has been compared to experimental data and helped understand the solute–solvent interactions. The sigma profile (σ-profile) of the molecules obtained by COSMO-SAC showed that alkyl parabens have similarities to ethanol, n-propanol, and 2-propanol. Additionally, the solubility of the parabens increased with the chain size due to the increase in their lipophilicity. This fact corroborated with the experimental data obtained. The solubility was also favored with the temperature increasing. Thus, a determination of the solubility of parabens in different solvents was collected to obtain complete physicochemical data, contributing to the projection and expansion of industrial applications of these compounds as excipients in liquid formulations.

Modification of purple sweet potato starch (Ipomoea batatas L. Poir) with pragelatination and acetylation methods as disintegrant of paracetamol tablets

Background: Starch of sweet potatoes is one of the ingredients that has many benefits, including in the pharmaceutical field, especially as a pharmaceutical excipient in pharmaceutical formulations. But it has poor flow properties. Objective: The objective of the study is to isolate, characterise, modify and formulate the starch of Purple sweet potatoes (I. batatas L.Poir) into tablet dosage forms. Method: purple sweet potato starch obtained from the isolation, then modified to improve its flow properties. Modifications made were by pregelatination and acetylation. after obtaining starch that meets the standards in the pharmacopoeia, then starch is used as a disintegrant in the formulation of paracetamol tablets with a concentration of 15%. Result: The physicochemical characteristics of starch isolated from purple sweet potatoes are considered to meet the requirements of pharmaceutical excipients required in the Handbook of Pharmaceutical Excipients sixth edition and the United States Pharmacopeia 32nd edition. Conclusion: The starch from purple sweet potato has the potential as an alternative disintegrant for tablet formulation, but the amount used needs to be reduced so as not to produce brittle tablets.

Deep Eutectic Solvents for Efficient Drug Solvation: Optimizing Composition and Ratio for Solubility of β-Cyclodextrin.

Deep eutectic solvents (DESs) show promise in pharmaceutical applications, most prominently as excellent solubilizers. Yet, because DES are complex multi-component mixtures, it is challenging to dissect the contribution of each component to solvation. Moreover, deviations from the eutectic concentration lead to phase separation of the DES, making it impractical to vary the ratios of components to potentially improve solvation. Water addition alleviates this limitation as it significantly decreases the melting temperature and stabilizes the DES single-phase region. Here, we follow the solubility of β-cyclodextrin (β-CD) in DES formed by the eutectic 2:1 mole ratio of urea and choline chloride (CC). Upon water addition to DES, we find that at almost all hydration levels, the highest β-CD solubility is achieved at DES compositions that are shifted from the 2:1 ratio. At higher urea to CC ratios, due to the limited solubility of urea, the optimum composition allowing the highest β-CD solubility is reached at the DES solubility limit. For mixtures with higher CC concentration, the composition allowing optimal solvation varies with hydration. For example, β-CD solubility at 40 wt% water is enhanced by a factor of 1.5 for a 1:2 urea to CC mole ratio compared with the 2:1 eutectic ratio. We further develop a methodology allowing us to link the preferential accumulation of urea and CC in the vicinity of β-CD to its increased solubility. The methodology we present here allows a dissection of solute interactions with DES components that is crucial for rationally developing improved drug and excipient formulations.

Investigation of the effect of concurrently administered carvedilol, atorvastatin and bile salts on intestinal absorption of linagliptin.

The aim of this work was to investigate the regional difference in linagliptin intestinal membrane transport and to investigate the effects of carvedilol, atorvastatin and bile salts on intestinal absorption of linagliptin. The study employed an in-situ rabbit intestinal absorption technique. The membrane transport parameters of linagliptin were determined through duodenum, jejunum, ileum and colon segments. The effect of carvedilol, atorvastatin and sodium cholate was investigated by co-perfusion of each with linagliptin through jejunum and ileum. The study reflected incomplete linagliptin absorption from the explored intestinal segments. The resulted rank indicated that the extent of absorption decreases as we move distally through the small intestine before increasing at the ascending colon. This behaviour suggests a role of P-glycoprotein (P-gp) efflux on reduced linagliptin intestinal absorption. Co-perfusion with carvedilol, atorvastatin or bile salts significantly enhanced linagliptin absorption. This elects P-gp efflux inhibition as one possible mechanism for enhanced linagliptin intestinal membrane transport. The study confirmed the role of P-gp efflux transporters in reduced intestinal linagliptin absorption. Co-administration of linagliptin with either carvedilol or atorvastatin can modulate the oral bioavailability of linagliptin. Bile salts can be employed as a formulation excipient for enhanced oral absorption of linagliptin.

A high throughput approach of selecting excipients for solubility enhancement of BCS Class II active pharmaceutical ingredients for oral dosage forms

Scientists have been faced with the challenge of selecting the right solubilizing excipients for solubility enhancement of poorly water-soluble active pharmaceutical ingredients for decades. In this investigation, the purpose was to ease some of those challenges by developing a first-intent matrix for selecting solubilizing excipients that may potentially be used in an oral solid dosage formulation. This was accomplished by generating 2304 data points using high throughput experimentation to assess the impact of eleven commonly used formulation excipients, at varying levels, on the solubility enhancement of a weak acid (Ibuprofen), weak base (Cinnarizine), and non-ionizable (Griseofulvin) drug substance over a time span from 1 h to equilibrium in simulated gastrointestinal fluids (SGF, FaSSIF, FeSSIF) and water. The results indicate that the enhancement of drug concentrations by use of solubilizing excipients (surfactants and stabilizers) in oral solid dosage forms depends on the type, the amount of excipient, and the pH of the media. The importance of this work is that formulation scientists now have a new addition to the formulation development toolkit for selecting the right solubilizing excipients and amounts suitable for solubility enhancement based on the class of active pharmaceutical ingredients. This first-intent solubilizer selection approach for the different drug classes simplifies the early development process to enable acceleration to candidate selection, formulation design, and product development for first-time-in-human studies.

Enhanced solubilization in multi-component mixtures: Mechanism of synergistic amplification of cyclodextrin solubility by urea and inorganic salts

Designed to enhance the solubility of hardly soluble species in water, many excipient formulations for active drugs or other solutes contain two or more cosolutes. And yet, little is known about the mechanism through which excipients act in combination, and how the efficacy of each component toward drug solubility changes compared to when they are acting alone. Here we study aqueous mixtures of urea and inorganic salts and determine their efficacy to solubilize β-cyclodextrin, a cyclic carbohydrate and a key ingredient in many drug formulations. We show that the order in which the salts increased β-cyclodextrin solubility follows the Hofmeister series both in the presence and absence of urea. However, the solubility in many of the urea-salt mixtures is notably higher than the sum of the solubilities in each cosolute on its own, suggesting a synergistic effect between solutes. By determining the activity of urea and NaClO4, the combination showing the strongest synergy, we show that their remarkable solubility enhancement at high concentration is due to a strong urea-assisted accumulation of NaClO4 at the vicinity of β-cyclodextrin. We discuss the molecular interactions that lead to this induced accumulation of NaClO4. Our findings provide new insight into the mechanism of solvation by multiple cosolutes and should aid in the rational design of tailored excipient formulations.

Stability of trastuzumab during nanomedicine formulation using SEC-HPLC coupled with polyacrylamide gel electrophoresis

The anti-HER2 antibody trastuzumab has been proven to be an effective targeting ligand for drug delivery. This study investigates the structural integrity of trastuzumab under different stress factors in formulation development and its long-term stability. A validated size exclusion high performance liquid chromatographic (SEC-HPLC) method was first developed. The stability of trastuzumab (0.21–21 mg/ml) under stress conditions (mechanical, freeze-and-thaw, pH and temperature) and long-term storage in the presence of formulation excipients were monitored for up to 12 months, using both the SEC-HPLC method and sodium-dodecyl sulphate-polyacrylamide gel electrophoresis (SDS-PAGE). The anti-proliferation activity of the reconstituted antibody stored at 4 °C against HER2+ BT-474 breast cells was also monitored over 12 months. The developed SEC-HPLC method was sensitive and accurate. Solutions of trastuzumab were resistant to mechanical stress and repeated freeze-and-thaw; but were unstable under acidic (pH 2.0 and 4.0) and alkaline (pH 10.0 and 12.0) environments. The samples degraded over 5 days at 60 °C, and within 24 h at 75 °C. Low temperature (-80 °C or 4 °C) and low concentration (0.21 mg/ml) favoured the long-term stability. The anti-proliferation activity was conserved at 4 °C for at least 12 months. This study provided valuable stability information in developing trastuzumab involved nano-formulation as well as in clinical settings.

Multidimensional Protein Solubility Optimization with an Ultrahigh-Throughput Microfluidic Platform.

Protein-based biologics are highly suitable for drug development as they exhibit low toxicity and high specificity for their targets. However, for therapeutic applications, biologics must often be formulated to elevated concentrations, making insufficient solubility a critical bottleneck in the drug development pipeline. Here, we report an ultrahigh-throughput microfluidic platform for protein solubility screening. In comparison with previous methods, this microfluidic platform can make, incubate, and measure samples in a few minutes, uses just 20 μg of protein (>10-fold improvement), and yields 10,000 data points (1000-fold improvement). This allows quantitative comparison of formulation excipients, such as sodium chloride, polysorbate, histidine, arginine, and sucrose. Additionally, we can measure how solubility is affected by the combinatorial effect of multiple additives, find a suitable pH for the formulation, and measure the impact of mutations on solubility, thus enabling the screening of large libraries. By reducing material and time costs, this approach makes detailed multidimensional solubility optimization experiments possible, streamlining drug development and increasing our understanding of biotherapeutic solubility and the effects of excipients.

SUSTAINABLE SYNTHESIS AND CHARACTERIZATION OF TUNABLE AND MULTIPURPOSE NANOCELLULOSE FROM FRESHWATER AQUATIC WEED AS PHARMACEUTICAL EXCIPIENT

Objective: The main objective of this work was to understand the basic properties of crystalline nanocellulose (CNC) that can be useful as a novel excipient in pharmaceutical formulations. This covers the isolation and preparation of nanocellulose followed by characterization. Methods: Cellulose was isolated from aquatic weed by autoclaving and bleaching. Cellulose to CNC conversion involved gluconic acid treatments at different concentrations (40%, 50% and 60%) followed by centrifugation and neutralization. CNC was further characterized by Differential Scanning Calorimetry (DSC) and Thermo gravimetric Analysis (TGA), Field Emission Scanning Electron Microscopy (FE-SEM) and Atomic Force Microscopy (AFM) for surface morphology, elemental analysis by Energy Dispersive Spectroscopy (EDS), Fourier Transform Infrared Spectroscopy (FTIR), crystallinity index by X-Ray Diffraction (XRD), and optical microscopy. Results: Acid concentration affects the moisture uptake, particle size, and yield of CNC. CNC size ranged from 350 nm to 900 nm with a crystallinity index 80% to 85%. Moisture uptake was 6.38±0.12% at 33% relative humidity. DSC and TGA established thermal stability over 200 °C. Nanocellulose has shown Angle of repose (28.81°), Carrs index (12.32), zeta potential (33mV) values and heavy metals within pharmacopoeial limits. Conclusion: CNC from water hyacinth was prepared successfully by sustainable process. CNC physico-chemical characterization revealed the stable nature of CNC, suitable to be used as an excipient in pharmaceutical formulations.

Fabrication of Novel Omeprazole-Based Chitosan Coated Nanoemulgel Formulation for Potential Anti-Microbia; In Vitro and Ex Vivo Characterizations.

Infectious diseases remain inevitable factors for high mortality and morbidity rate in the modern world to date. Repurposing is a novel approach to drug development has become an intriguing research topic in the literature. Omeprazole is one of the top ten proton pump inhibitors prescribed in the USA. The literature suggests that no reports based on omeprazole anti-microbial actions have been discovered to date. This study entails the potential of omeprazole to treat skin and soft tissue infections based on the literature's evident anti-microbial effects. To get a skin-friendly formulation, a chitosan-coated omeprazole-loaded nanoemulgel formulation was fabricated using olive oil, carbopol 940, Tween 80, Span 80, and triethanolamine by high-speed homogenization technique. The optimized formulation was physicochemically characterized for zeta potential, size distribution, pH, drug content, entrapment efficiency, viscosity, spreadability, extrudability, in-vitro drug release, ex-vivo permeation analysis, and minimum inhibitory concentration determination. The FTIR analysis indicated that there was no incompatibility between the drug and formulation excipients. The optimized formulation exhibited particle size, PDI, zeta potential, drug content, and entrapment efficiency of 369.7 ± 8.77 nm, 0.316, -15.3 ± 6.7 mV, 90.92 ± 1.37% and 78.23 ± 3.76%, respectively. In-vitro release and ex-vivo permeation data of optimized formulation showed 82.16% and 72.21 ± 1.71 μg/cm2, respectively. The results of minimum inhibitory concentration (1.25 mg/mL) against selected bacterial strains were satisfactory, suggesting a successful treatment approach for the topical application of omeprazole to treat microbial infections. Furthermore, chitosan coating synergistically increases the antibacterial activity of the drug.

“Lactose free” depression- Antidepressant with and without lactose registered in Croatia

IntroductionDepression is a common illness worldwide, with an estimated 3.8% of the population affected, including 5.0% among adults and 5.7% among adults older than 60 years. Lactose intolerance affects 70% of the world population. With both conditions being common there are a lot of people having both lactose intolerance and depression. People with lactose intolerance are unable to fully digest lactose. As a result, they have diarrhea, bloating and gas after eating or drinking dairy products. Lactose is one of the most used excipients in drug formulations and is ofteny overlooked when prescribed.ObjectivesTo quantify and identify the amount of lactose in medications used for the treatment of depression and to identify ‘lactose-free’ medication registered in Croatia.MethodsMedications used for the treatment of depression were identified from the Agency for medicinal products and medical products of Croatia (HALMED). Their formulation including excipients was obtained from the Agency.ResultsWide range of antidepressants contains lactose. We have quantified the lactose amount using information on medicinal products with marketing authorisation granted by HALMED. AntidepressantBrand name and dosageLactose per tablet (mg)SertralineSonalia ® 50 mg19.80mgParoxetineParoksetin PharmaS®10mgEscitalopramEscital ® 10mg117.8mgElicea ® 5mg51.3mgCitalopramCitalon ® 20mg23mgMirtazapineCalixta ® 15mg44.4mgMirzaten ® 30mg120.56mgMirzaten Q tab ® 15mg35.63mgConclusionsWith this research, we have pointed out a high proportion of the most commonly prescribed antidepressants that contain lactose. Considering the high proportion of the general population with lactose intolerance, we have pointed out the importance of knowing the data that antidepressants do not contain lactose in order to choose an adequate therapy for our patients, while not causing them discomfort that will further reduce the effectiveness of the therapy, as well as increase the percentage of those who due to the side effects of the drug, they stop taking the therapy. This research will help clinicians in their daily work to choose the most optimal therapy for their patients. With this study, we will give doctors a list of medications for depression treatment without lactose. With this study, we will give doctors a list of medications for depression treatment without lactose.Disclosure of InterestNone Declared