Concentration Of Superdisintegrants Research Articles

Preparation and Optimization of Ivabradine Hydrochloride Mouth-Dissolving Tablet

The aim of the present work was the preparation and optimization of mouth-dissolving tablets (MDTs) of Ivabradine hydrochloride by using natural super disintegrants. The tablets were prepared using microcrystalline cellulose as diluent and aspartame as a sweetening agent along with Natural super disintegrants. The natural super disintegrants used in this study were Guar Gum and Banana powder. By using natural superdisintegrants we had saved the environment and protected our bodies from the harmful effect of synthetic superdisintegrants. The tablet was prepared by the direct compression method. The 6mm of punch was used and the tablet weight is 110 mg. The tablets were evaluated for weight variation, hardness, friability, wetting time, disintegration time (DT), and dissolution study. Different concentration of superdisintegrants was used in this formulation as 6%, 8%, and 10%. The three batches of guar gum and 3 batches of banana powder were prepared i.e., a Total of six batches were prepared. From the results obtained, it can be concluded that the tablet formulation prepared with 10% banana powder i.e., 10 mg showed fast and higher drug release (98.66%) during in vitro dissolution study. Also, the hardness, friability, dissolution rate, and assay of prepared tablets (batch F6) were found to be acceptable according to standard limits. The result was the F6 batch was optimized batch from all the batches.

Formulation and evaluation of oral dispersible tablet of nimesulide by direct compression method

Based on Biopharmaceutics Classification System (BCS), nimesulide is a class II drug, characterized by low solubility and high permeability. Thus, its dissolution represents a limiting step in the drug absorption process which directly affects the bioavailability of the drug. Oral Dispersible tablets (ODTs) of nimesulide overcome the problem related to dissolution by enhancing the rate of dissolution by decreasing the disintegration time and making it easy to administer to patients who refuse to swallow a tablet. In the present study, different formulations of nimesulide were prepared to vary the concentration of superdisintegrants: crospovidone, croscarmellose sodium, sodium starch glycolate along with other excipients: PVP K-30, Aerosil, Mannitol, and Magnesium stearate by direct compression method. Precompression and post-compression parameters were evaluated and also the effect of different concentrations of superdisintegrants on the release profile of Nimesulide ODT was studied. The final data revealed that a combination of 10% crospovidone and 8.33% SSG i.e. formulation B4 was found best combination with the lowest dispersion time of 40 seconds, lowest disintegration time of 19.16 seconds, and lowest wetting time of 15 seconds as compared to other formulations. All other studied parameters were found to be satisfactory for all ODT formulations for Nimesulide. It was concluded that Nimesulide can be successfully formulated as oral dispersible tablets using various superdisintegrants in different concentrations by direct compression method. The optimized batch can be subjected to real-time and accelerated stability studies to determine the shelf life for commercial use.

Formulation and Evaluation of Bi-Layer Tablet of Nebivolol and Nateglinide

In the present work, the Bilayered matrix type tablet were prepared by direct and wet granulation technique, in which immediate release layer ( by direct compression) contains Nebivolol and extended release layer (by wet granulation) contains Nateglinide. All the developed bilayer tablets were evaluated for weight variation, friability, thickness and hardness. The percent deviation from the average weight, friability, thickness and hardness was found to be within the prescribed official limits. Release profile of Nebivolol from formulations indicate that lower MCC (Formulations CF1 and CF3) and lactose (Formulation CF3) content displayed higher release rates as compared to formulation with higher MCC and lactose content (Formulation CF2). Also the concentration of KYRON T-314 is also found to influence the release rate of the drug. It was found that formulation containing the highest concentration of superdisintegrants (Formulation CF3) has grater release then other subsequent formulations (Formulations CF1 and CF3). Similarly, the release profile of Nateglinide from formulations indicate that lower HPMC K15M (Formulation CF3) and lactose (Formulation CF3) content displayed higher release rates as compared to formulation with individual HPMC K15M, HPMC K100M, EC (Formulations CF1 and CF2) and higher lactose content (Formulations CF1 and CF2).

Formulation and Evaluation of Mouth Dissolving Tablet Rivaroxaban and its Validation

ABSTRACT: The foremost intention of present research was the preparation and assessment of mouth dissolving formulation Rivaroxaban and its validation. During present work, this tablet was formulated by straight compression technique by means of Cros-carmellose sodium and Sodium starch glycolate as super-disintegrants (concentration of 2, 4, 6%) and Avicel 102 as a binder. The formulated preparations were exposed to different consideration parameters like hardness test, friability test, disintegration test, release of drug and content of drug. The calibration curve of API using solvent phosphate buffer pH 6.8 was carried out. All prepared formulations exposed to different assessment parameters have shown the findings within prescribed limit. Due to the large concentration of super disintegrants in F8, disintegration time can reach 29±0.06 seconds. In used buffer, drug release was calculated at intervals of 0, 2, 4, 6, 8, 10, and 12 minutes. The F8 demonstrates 96.5±0.567 percent medication release. UV spectrophotometric validation was performed for the quantification of Rivaroxaban in bulk. Rivaroxaban was estimated at 247nm in phosphate buffer 6.8. The linearity range was observed 2–12µg/ml.

Formulation and Evaluation of Salbutamol Sulphate Taste Masked Oral Disintegrating Tablets

Salbutamol is a short acting, selective beta2-adrenergic receptor agonist used in the treatment of astama and COPD. The aim of this study is to formulate oral disintegrating tablets of salbutamol sulphate to achieve rapid dissolution, absorption and further improving the bioavailability of the drug. Oral disintegrating tablets of salbutamol sulphate were designed with a view to enhance the patient compliance and provide a quick onset of action. The oral disintegrating tablets were prepared by using different synthetic polymers by direct compression method. Development of the formulation in the present study was based on the concentration of superdisintegrants and the properties of the drug. Nine batches of tablets were formulated and evaluated for various parameters: drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, hardness, friability, thickness uniformity, and in vitro dissolution. A fourier-transform infrared spectroscopy (FTIR) study showed that there were no significant interactions between the drug and the excipients. The prepared tablets were good in appearance and showed acceptable results for hardness and friability. The in vitro disintegrating time of the formulated tablets was found to be 14.39-32.41 sec and the drug content of tablets in all formulations was found to be between 87.48-99.96 %, which complied within the limits established in the Indian pharmacopeia. The study concluded that taste of the drug was masked with the help of sodium saccarhin, flavor and the concentration of super disintegrating agent increases the disintegration time of tablets get decreases. The formulation (F9) had a minimum disintegration time of 14.39 sec and 99.96 % of the drug was released within 20 min.

Factorial Design Based Optimisation of Metoclopramide Hydrochloride Fast Dissolving Tablets

Aim of the study The present investigation was aimed at developing taste masked fast dissolving tablets FDT of metoclopramide hydrochloride using 23 factorial design model.Materials and methods Metoclopramide hydrochloride is used as antiemetic drug and is intensely bitter in taste. The bitterness of drug was reduced by using a combination of flavour and complexing with beta-Cyclodextrins.The taste masking ability of complex was evaluated in healthy human volunteers. The taste masked fast dissolving tablet was developed by direct compression method using superdisintegrants like sodium starch glycolateSSG croscarmellose sodium CCS and crospovidone CP in different concentration as per 23 factorial design model.Results and conclusions The physico-chemical properties of tablets were evaluated prior to in vitro release studies. The hardness 4.7plusmn0.12 - 5.0plusmn0.20 kgcm2 friability 0.07plusmn0.22 - 0.83plusmn0.24 drug content 9.40plusmn0.36 - 10.46plusmn0.21 mg and disintegration time 8.24plusmn0.46 - 90.00plusmn0.70 sec of FDT were found uniform and acceptable as per limits. ANOVA was used to determine the significant effect. The model was found to be significant at the level of probability plt0.05 for disintegration time and also dissolution rate as well. From contour plots obtained the formula of optimized tablet was predicted. The optimised concentration of superdisintegrants was 15.6 mg of SSG 9.80 mg of CCS and 9.40 mg of CP. Optimised formula F9 gave disintegration time of 8.24plusmn0.46 sec and 99.262 of drug release. The formulations followed first order mechanism of release r20.793 ndash 0.926.

Formulation of Furosemide Oral Disintegrating Tablets Using Natural and Synthetic Superdisintegrants by SeDeM Expert Design System

SeDeM design expert technique used to evaluate the risks of poor flow of pharmaceutical powders under preformulation studies which reveals direct compression suitability and prepare robust composition of active pharmaceutical ingredient (API) and excipient in tablets formulation. The purpose of this study was to develop oral disintegrating tablets of Furosemide using different concentration of natural and synthetic superdisintegrants by means of SeDeM design technique. Oral disintegrating tablets (ODT) of Furosemide were prepared by direct compression technique using isolated banana powder and croscarmellose sodium (Ac-di-sol) together with microcrystalline cellulose as superdisintegrants. SeDeM design was performed to check suitability and deficient of excipients and drug for optimized composition derived based on IPP value. These tablets were evaluated for hardness, friability, drug content, weight variation, wetting time and in-vitro dissolution. All the formulations showed low weight variation with dispersion time less than 173.5±0.70 seconds and rapid in-vitro dissolution. The drug content of all the formulations was within the acceptable limits. Lubricated blend composition of F4 found average radius value 5.24, 0.66 and 5.509 for IGC, IP and IPP respectively, compressed tablet shown good physical properties. The optimized formulation F4 showed good release profile with 99.25 percentage drug release compared to other trial batches. It was concluded that natural superdisintegrant (banana powder) showed better disintegrating property than synthetic super disintegrant (Ac-di-sol) in the formulations of ODTs.
 Keywords: Furosemide, Oral disintegrating tablets, SeDeM expert system, Superdisintegrants

Formulation and Characterization of Aceclofenac Mouth Dissolving Tablet by QbD

The purpose of this study was to develop fast dissolving tablets of Aceclofenac using different concentration of super disintegrants. Fast dissolving tablets of Aceclofenac were prepared by dry granulation technique using croscarmellose sodium together with avicel ph as superdisintegrants. The porous granules were then compressed in to tablets by direct compression technique. These tablets were evaluated for drug content, weight variation, friability, hardness, wetting time and dispersion time. All the formulations showed low weight variation with dispersion time less than 90 seconds and rapid in vitro dissolution. The drug content of all the formulations was within the acceptable limits. The optimized formulation showed good release profile i.e. maximum drug being released at all-time intervals compared to other trial batches. It was concluded that fast dissolving tablets with improved dissolution could be prepared by dry granulation method of tablet.
 Keywords: Aceclofenac, fast dissolving tablet, dry granulation, super disintegrants.

FORMULATION AND EVALUATION OF MOUTH DISSOLVING TABLET OF AMLODIPINE BESYLATE

Objective: The main objective of this research work was to formulate and evaluate the mouth dissolving tablet of amlodipine besylate for the treatment of hypertension and coronary artery disease.
 Methods: In this study, mouth dissolving tablet were prepared by direct compression method by using croscarmellose sodium and sodium starch glycolate as superdisintegrants. The designed tablets were subjected to various assessment parameters like friability test, hardness test, disintegration test, wetting time, in vitro drug release and drug content.
 Results: All the prepared formulations were subjected to various assessment parameters, and the findings obtain within the prescribed limit. The calibration curve of pure drug using various solvents like phosphate buffer pH 6.8, methanol was plotted. F1-F9 containing croscarmellose sodium and sodium starch glycolate in various concentration demonstrate the minimum disintegration time. Among all these formulations F9 shows disintegration time up to 22±1.12 seconds due to the high concentration of superdisintegrants. In vitro drug release was tested in phosphate buffer pH 6.8 at a time interval of 0, 1, 2, 3, 4, 5 min. The F9 shows drug release 100.22±1.08%. Accelerated stability study of optimized formulation (F9) up to 2 mo showed there was no change in disintegration time and percentage drug release.
 Conclusion: The results obtained in the research work clearly showed a promising potential of mouth dissolving tablets containing a specific ratio of croscarmellose sodium and sodium starch glycolate as superdisintegrants for the effective treatment of hypertension and coronary artery disease.

Design development and optimization of immediate release tablet of valsartan

The objective of the present study was to prepare immediate release tablets (IRTs) of valsartan by direct compression method. Two types of superdisintegrants i.e. sodium starch glycolate (SSG) and Ac-Di-sol were used in the formulation of tablets. Twelve preliminary trial batches were prepared by varying the concentration of superdisintegrants. It was found that formulation containing Ac-Di-Sol disintegrated in less time as compared to formulation containing sodium starch glycolate. Values of friability was found to be more in case of formulation containing Ac-Di-Sol. Attempts were also made to prepare the tablets containing superdisintegrants in combination and these resulted in the formulation with improved values of disintegration time and friability. On the basis of preliminary studies optimization of IRT was done employing 32 full factorial design using design expert 7. The optimized batch of IRTs showed friability and disintegration time values of 0.82 ± 0.07 and 29 ± 1 respectively. The percent release was also found to be 94.73 ± 4.97% in 5 min. Keywords: Immediate release tablets, Valsartan, Hypertension, Sodium starch glycolate, Ac-Di-Sol, 32 full factorial design

Design, development and optimization of immediate release tablet of deflazacort

The objective of the present study was to prepare immediate release tablets (IRTs) of deflazacort by direct compression method. Two types of superdisintegrants i.e. sodium starch glycolate (SSG) and Ac-Di-sol were used in the formulation of tablets. Twelve preliminary batches were prepared by varying the concentration of superdisintegrants. It was found that formulation containing Ac-Di-Sol disintegrated in less time as compared to formulation containing sodium starch glycolate. Values of friability was found to be more in case of formulation containing Ac-Di-Sol. Attempts were also made to prepare the tablets containing superdisintegrants in combination and these resulted in the formulation with improved values of disintegration time and friability. On the basis of preliminary studies optimization of IRT was done employing 32 full factorial design using design expert 7. The optimized batch of IRTs showed friability and disintegration time values of 0.598 and 64.17±3.50 respectively. It was also found that 96.26±1.82% of drug was released within 5 min.
 Keywords: Immediate release tablets, deflazacort, Rheumatoid arthritis, Sodium starch glycolate, Ac-Di-Sol, 32 full factorial design

Formulation and characterization of oral rapid disintegrating tablets of levocetirizine.

Levocetirizine, active R (-) enantiomer of cetirizine, is an orally active and selective H1 receptor antagonist used medically as an anti-allergic. Allergic rhinitis is a symptomatic disorder of the nose induced by inflammation mediated by immunoglobulin E (IgE) in the membrane lining the nose after allergen exposure. The purpose of the present study was to prepare rapidly disintegrating tablets of levocetirizine after its complexation with β-cyclodextrin (β-CD). Levocetirizine-β-CD complex tablets were prepared by direct compression technique using 3 synthetic superdisintegrants in different proportions. Development of the formulation in the present study was mainly based on the concentration of superdisintegrants and the properties of the drug. Nine batches of tablets were formulated and evaluated for various parameters: drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, hardness, friability, thickness uniformity, and in vitro dissolution. A Fourier-transform infrared spectroscopy (FTIR) study showed that there were no significant interactions between the drug and the excipients. The prepared tablets were good in appearance and showed acceptable results for hardness and friability. The in vitro disintegrating time of the formulated tablet batches was found to be 15-35 s percentage and the drug content of tablets in all formulations was found to be between 90-102%, which complied with the limits established in the United States Pharmacopeia. Complexation of levocetirizine with β-CD significantly improves the solubility of the drug. The disintegration time of the tablets was decreased with an increase in superdisintegrant amount. The tablets (batch CPX5) had a minimum disintegration time of 20 s and 99.99% of the drug was released within 10 min.

FORMULATION AND IN VITRO EVALUATION OF ORAL DISINTEGRATING TABLETS OF AMLODIPINE BESYLATE

Objective: The present investigation was undertaken with an objective of formulating oral disintegrating tablets of amlodipine besylate to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy.Methods: The tablets were prepared by using direct compression method and evaluated for weight variation, hardness, friability, wetting time, disintegration time and in vitro drug release study. Prepared tablets were evaluated for compatibility by Fourier transform infrared spectroscopy.Results: Fourier transform infrared spectroscopy studies revealed that there was no physicochemical interaction between amlodipine besylate and other excipients. All the tablets hardness was found to be around 3.5 kg/cm2 and friability of all the formulations was less than 1%, Drug content in all the formulations was found in the range of 97.05% to 99.13%.Conclusion: The study clearly indicated that the type and concentration of superdisintegrants plays an important role in disintegration and dissolution of drug from oral disintegrating tablets. Among all the formulations, the maximum percentage of drug release and less disintegration time was found in F9 formulation containing 4% of crospovidone.

Formulation and Evaluation of Immediate Release Film Coated Tablets of An Anticancer Drug (Dasatinib)

Aim: The objective of the present study was to develop an immediate release tablet of Dasatinib using different concentration of superdisintegrants with a view to obtain rapid action for myelogenous leukemia and acute lymphoblastic leukemia[1]. Dasatinib is a chemotherapy medication used to treat certain cases of leukaemia. Materials and Methods: Various formulations were prepared by direct compression technique using super disintegrants (cross carmellose sodium, sodium starch glyclote and crospovidone). Effect of different superdisintegrants on drug release was studied. Optimized formulation was selected on the basis of drug release and its in-vitro release profile compared with the reference product (Sprycel). Results and Discussion: The dissolution results showed gradient increase in the drug release with the increase in concentration of the super-disintegrants. Conclusion: Among all the formulations F3 containing croscarmellose sodium (4.5%) was found to show best results with 98.3% release within 45 minutes and it exhibited a release profile comparable to the reference product.

Studies on Orally Disintegrating Tablets Prepared by Using Natural and Synthetic Superdisintegrants

The objective of present study was to compare the disintegration efficiency of mucilage isolated from Plantago ovata with commonly used synthetic superdisintegrant, croscarmellose sodium in the formulation of orally disintegrating tablets. Effects of varying concentration of both superdisintegrants on disintegration time were studied. Orally disintegrating tablets of metoclopramide hydrochloride were prepared using selected superdisintegrants by direct compression technique. Prepared tablets were evaluated for weight variation, thickness, hardness, friability, disintegration time, wetting time, water absorption ratio and dissolution test. Swelling index was also investigated for comparing the swelling property of croscarmellose sodium with mucilage of Plantago ovata. Swelling index of mucilage isolated from Plantago ovata was found to be greater (94 ± 2.5% v/v) when compared with croscarmellose sodium (85 ± 1.5% v/v). The present study indicated that mucilage isolated from natural source proved to be more effective for their disintegrating property than the most commonly used synthetic superdisintegrant, croscarmellose sodium.

FORMULATION AND IN VITRO EVALUATION OF FAST DISSOLVING TABLET OF VERAPAMIL HYDROCHLORIDE

Objective: The main objective of this research work was to formulate and evaluate fast dissolving tablet of verapamil hydrochloride for the treatment of hypertension.Methods: In this study, fast dissolving tablet were prepared by wet granulation method by using croscarmellose sodium and sodium starch glycolate as superdisintegrants in the concentration of 2%, 4%, and 6%. Polyvinyl pyrollidone K30 is used as a binder. The designed tablets were subjected to various assessment parameters like friability test, hardness test, disintegration test, wetting time, in vitro drug release and drug content.Results: All the prepared formulations were subjected to various assessment parameters, and the findings obtain within the prescribed limit. The calibration curve of pure drug using various solvents like distilled water, phosphate buffer pH 6.8 was plotted. F1-F9 containing croscarmellose sodium and sodium starch glycolate in various concentration demonstrate the minimum disintegration time. Among all these formulations F8 shows disintegration time upto 19±0.06 seconds due to the high concentration of superdisintegrants. In vitro drug release was tested in phosphate buffer pH 6.8 at a time interval of 0, 1, 3,6,9,12,15 min. The F8 shows drug release 98.5±0.567%. Accelerated stability study of optimized formulation (F8) up to 2 mo showed there was no change in disintegration time and percentage drug release.Conclusion: The results obtained in the research work clearly showed a promising potential of fast dissolving tablets containing a specific ratio of crosscarmellose sodium and sodium starch glycolate as superdisintegrants for the effective treatment of hypertension.

FORMULATION AND EVALUATION OF FAST DISINTEGRATING LOSARTAN POTASSIUM TABLETS BY FORMAL EXPERIMENTAL DESIGN

In the treatment of hypertension fast onset of action is the major concern. The problem of slow onset of action of drugs can be overcome by development of appropriate dosage forms. Fast disintegrating tablets in mouth are best suited and have gained popularity in the oral antihypertensive drug therapy. These are advantageous over other conventional systems in terms of patient compliance, rapid onset of action, accurate dosing, good chemical stability, convenience of self-administration and compactness. Losartan potassium is widely used as an antihypertensive drug, which is a potent drug candidate for developing in to Fast Dissolving Tablets (FDT’s). It has low bioavailability due to first pass metabolism. Hence the main objective of the study was to formulate fast dissolving tablets of Losartan potassium to achieve a better dissolution rate and further improving the bioavailability of the drug. Fast dissolving tablet of Losartan potassium were formulated by using microcrystalline cellulose with different concentration of super disintegrants like sodium starch glycolate and Isabgol Mucilage. All the batches were prepared by direct compression.
 API characterization studies were conducted to check the purity of API .The tablets were evaluated for Pre compression parameters and post compression parameters. Before the formulation of the tablets IR spectroscopic studies were also performed to check the compatibility with the excipients.
 A 23 full factorial design was applied to investigate the combine effect of 3 formulation variables. Here the concentration of Isabgol mucilage, concentration of Sodium Starch Glycolate and concentration of Microcrystalline Cellulose were taken as independent variable X1, X2 & X3 respectively and their effect of disintegration time is studied as dependent parameter. To represent the data Design Expert software is used.

Formulation and evaluation of immediate release tablet of risperidone

The main objective of the present investigation was to formulate Risperidone immediate release tablet. Risperidone, an antipsychotic drug mainly act as a D2 and 5HT2A receptor antagonist. Superdisintegrants agents like kollidon and citric acid were used and compressed into tablet by direct compression method. Risperidone is mainly used to treat schizophrenia bipolar disorder. The six formulations having different concentration of superdisintegrants were prepared and formulation blend was examined for angle of repose, bulk density tapped density and compressibility. The tablet were evaluated for various parameters like hardness, thickness, friability, weight variation, disintegration time and invitro dissolution time, all the parameter were found within limits.

Development and Evaluation of Mouth Dissolving Tablets using Natural Super Disintegrants

: Objective: To formulate a mouth dissolving tablets of dexamethasone for the use of paediatrics, geriatric patients and also dysphagic patients. Methodology: Tablets were formulated by using different types of natural Super disintegrants in different concentration such as Guar gum and Xanthan gum. A manual 7 mm single punch tablet compression machine was used to compress the tablet. Powder mixture of 150mg was weighed accurately and added into the die cavity. The prepared dexamethasone MDT tablets were evaluated for its physico-chemical parameters such as thickness, hardness, weight variation, friability, disintegration time, wetting time, in-vitro dispersion time, water absorption ratio and also in-vitro drug release. Results: The FTIR and DSC studies conferred that there is no interaction between dexamethasone and Super disintegrants. The dissolution profile of dexamethasone MDT compared with conventional dexamethasone tablet shows improved in % drug release and faster % drug release. An increase in the concentration of Super disintegrants showed faster % of drug release and similar % of cumulative drug release. Conclusion: Dexamethasone MDT using Guar Gum and Xanthan Gum could be considered as good formulation and delivery system to increase the patient’s compliance as the % drug release and disintegration time are much better than conventional Dexamethasone tablet. Key words: Mouth Dissolving Tablets, dexamethasone, Super disintegrants, Rapid disintegration, Dysphagia.

Evaluation of disintegrants functionality for orodispersible mini tablets

Objective: This work evaluates the functionalities of different superdisintegrants (SD) for manufacturing orodispersible mini tablets (ODMT) by direct compression.Methods: Twenty-three formulations varying in SD type, concentration, and lubricant were used to manufacture ODMT. The ODMT were then characterized for the following properties: friability, porosity, tensile strength, in vivo and in vitro disintegration time (DT).Results: The results show that the presence, type, and concentration of SD did not influence friability, porosity, or tablet tensile strength. With regards to in vivo DT, only cross-linked poly (vinyl pyrrolidone) improved DT in all the tested formulations. Results also showed that when using microcrystalline cellulose (MCC) above 20% in the formulation, DT is longer. Cross-linked carboxymethyl cellulose accelerates DT when the MCC content is less than 20%. As for cross-linked carboxymethyl starch and calcium alginate showed no improvement on DT. Results for in vitro DT were all shorter than in vivo results and there was no correlation with the in vivo evaluation.Conclusions: This study shows that there is a need to develop better in vitro testing that precisely simulates in vivo conditions and that are adapted to ODMT. This standardization of the test methods for ODMTs must be accompanied by an improvement in the comprehension of SD mechanisms.