Self-microemulsifying Research Articles

Defining the mechanisms behind the hepatoprotective properties of curcumin.

As a critical cause of human dysfunctionality, hepatic failure leads to approximately two million deaths per year and is on the rise. Considering multiple inflammatory, oxidative, and apoptotic mechanisms behind hepatotoxicity, it urges the need for finding novel multi-targeting agents. Curcumin is a phenolic compound with anti-inflammatory, antioxidant, and anti-apoptotic roles. Curcumin possesses auspicious health benefits and protects against several diseases with exceptional safety and tolerability. This review focused on the hepatoprotective mechanisms of curcumin. The need to develop novel delivery systems of curcumin (e.g., nanoparticles, self-micro emulsifying, lipid-based colloids, solid lipid nanoparticles, cyclodextrin inclusion, phospholipid complexes, andnanoemulsions) is also considered.

Formulation of Self Micro-Emulsifying Dry Powder of Zingiber officinale (Rhizome) and Its Effect on Hepatoprotective Activity in Mice Model

Liver complication is a major concern in the world. Finding out a new way to combat various liver diseases is very much required. Ginger has been reported to have hepato-protective activity. Here we aimed to formulate an oil-based (self-micro emulsifying) powder to improve the hepatoprotective activity of dry powder of Zingiber officinale (Ginger). Four different formulations of self-microemulsifying dry powder were prepared by mixing with different excipients. The formulated powder was characterized for the angle of repose, Hausner ratio and compressibility index. The hepato-protective activity of the formulated powder was evaluated in vivo. All of the parameters tested for powder characterization showed a good response in terms of flow property and compressibility. Formulated powder exhibited a significant decrease (p<0.05) in hepatic enzymes like aspartate transaminase (AST) and alanine transaminase (ALT) in carbon tetrachloride (CCl4) induced hepatotoxic mice compared to fresh ginger powder group which indicates the enhanced hepatoprotective activity of prepared self-micro emulsifying power in hepatotoxicity. Bangladesh Pharmaceutical Journal 26(2): 125-133, 2023 (July)

Sustained release gel (polymer-free) of itraconazole-loaded microemulsion for oral candidiasis treatment: time-kill kinetics and cellular uptake

Itraconazole (ICZ) was prepared in a self-microemulsifying (SM) gel. This gel was intended for use in the oral mucosa, where low volume and flow of saliva result in limited solubility and absorption of drugs that are poorly water-soluble. The drug-loaded gel formulation (ICZ-SM) was selected as a clear solution in the ternary phase diagram to improve the solubility of ICZ. Seven ratios (S1–S7) were prepared by mixing polyoxyl 35 castor oils (P35), a medium chain with a blend of mono-, di-, and triglycerides (MCT), and water. Phase separation of large-sized emulsions by countering with artificial saliva were observed in dilution tests for the formulation contained MCT, P35, and water at the ratios of 70:20:10 (S1), 10:80:10 (S3), and 20:60:20 (S4). Formulations in the ratios of 15:50:35 (S5) and 19:43:38 (S6) produced strong ICZ-SM gels, as shown by rheology tests, whereas the formulations at the ratios of 30:60:10 (S2) and 10:43:47 (S7) exhibited no elasticity. A model of zero-order kinetic (S5) and first-order kinetic (S6) were found to best fit the release kinetics of ICZ from the gels. Time-killing assays revealed that S5 and S6 required less time compared with S2 and the ICZ solution. Furthermore, S5 exhibited the highest increase in cell uptake compared with S2, S6, and the ICZ solution. These findings suggest that the ICZ-SM gel was a free polymer capable of delivering an ICZ for the treatment of oral candidiasis, and that ICZ-SM gels applied locally exhibit enhanced absorption into cells.

Formulation Development and Evaluation of Solid Self Microemulsifying Drug Delivery System of Azelnidipine

This study aimed to develop a self-micro emulsifying drug delivery system (SMEDDS) for poorly soluble azelnidipine using Capryol 90 as the oil, Tween 80 as the surfactant, and transcutol-HP as the co-surfactant. A factorial design was used to optimize the formulation, and Neusilin UFL2 was used as an adsorbent to convert the liquid SMEDDS to solid SMEDDS. The optimized formulation had a particle size of 80.5nm, a transmittance of 98.2%, a zeta potential of -3.1 mV, and a polydispersibility index of 0.226. The solid SMEDDS tablet exhibited improved drug release (99.4% in 60 minutes) compared to the marketed tablet (67.09.75%) and pure drug (26.17%). This study demonstrates the potential of the SMEDDS approach to enhance the solubility and in-vitro drug release of poorly soluble drugs such as azelnidipine.

LIPID AS AN EXCIPIENT FOR DESIGN AND DEVELOPMENT OF FORMULATIONS

Lipids are present abundantly in human body in several forms. Different types of lipids are available with diverse physical properties, based on which suitable lipids can be selected for development of formulations. Lipids are also available for specific purposes like lubrication, emulsification, emollientes and enhancement of bioavailability. Conventionally, many lipids are used in formulation of tablets, capsules, emulsions and cosmetics. In recent years, use of lipids for drug delivery has been extended to Solid Lipid Nanoparticles (SLN), Nanostructured Lipid Carriers (NLC), and Self-Micro Emulsifying Drug Delivery System (SEDDS), which are emerging technologies designed to address challenges like solubility and bioavailability of poorly water-soluble drugs. This paper mainly focuses on different types of formulations in which lipids are used, and parameters which are critical for selection of lipid in any dosage form development. Several examples are quoted for different uses of lipids. Finally challenges in use of lipids and regulatory aspects are discussed.

Formulation of Self-micro Emulsifying Drug Delivery Systems (SMEDDS) of Paclitaxel utilizing factorial design

Background: The antineoplastic drugs possess poor aqueous solubility along with low bioavailability. This limits delivery of antineoplastic drugs through oral route. SMEDDS is a well-accepted means for addressing the lower aqueous solubility and bioavailability issues of a lipophilic drugs. Paclitaxel (PTX) is an antineoplastic drug. PTX is found to be very useful in the treatment of ovarian and breast cancers. PTX have very low aqueous solubility (0.3 µg/ml). 
 Objective: This study aims to formulate SMEDDS incorporating PTX to enhance its aqueous solubility. 
 Methodology: Isopropyl myristate (IM), tween 80 (T80) and transcutol (TC) were used to formulate SMEDDS. IM was considered as oil, T80 as surfactant and TC as co surfactant. 32 factorial design analysis helps in studying the effect of an independent factor on a dependent factor on statistical principles. Independent factors, first – concentrations of oil, second – mixture of surfactant and co-surfactant (Smix), and two dependent factors, first – emulsification time and second – in vitro drug release were chosen. All the nine formulated B1-B9 were subjected to various physicochemical tests. 
 Result and discussion: The globule size was found to be 136.38 – 223.14 nm, zeta potential ranges between -31.54 to -7.58, drug content ranges between 65.34 – 83.56%. Statistical analysis shows that an increasing amount of surfactant decreases emulsification time. This may also decrease the average droplet size of resultant SMEDDS. When the concentration of tween 80 was increased, it was observed that the release of PTX also increased. Rapid and more extent of PTX released from formulated SMEDDS indicates that the aqueous solubility of PTX has increased. B9 formulation releases 99.46% PTX at end of 60 minutes whereas 35.23% of pure PTX powder was solubilized in dissolution medium. 
 Conclusion: This study states that the prepared SMEDDS possess acceptable properties to be considered as immediate release dosage forms. This conclusion was drawn based on in vitro release study.

Formulation and Evaluation of Self Micro-Emulsifying drug delivery System of Carvedilol

The current work involves preparation and evaluation of self-micro emulsifying drug delivery system of carvedilol, an nonselective betablocker and alpha-1 blocker. Oral self micro-emulsifying drug delivery system of Carvedilol were prepared by studying the solubility in different oils, surfactants and co-surfactants and formulations were prepared using mixtures of oils, surfactants, and cosurfactants in various proportions. Based on the solubility study, the optimised self micro-emulsifying drug delivery system of carvedilol was prepared using Capryol 90 as oil phase and tween 20 and transcutol P as surfactant and co-surfactant, respectively. The formulations were evaluated for stability, globule size and in vitro performance. To estimate the drug content from various excipients, final microemulsion formulations and in vitro performance study, a stability-indicating validated high-performance liquid chromatography method was developed using Inertsil ODS-3V (150 mm×4.6 mm, 5 μm) high-performance liquid chromatography column. The method was validated for various parametes like accuracy, linearity, precision (intraday and interday) and robustness. All the validation parameters were in acceptable range. The developed method was found to be specific accurate and robust for estimation of carvedilol from its microemulsion formulations.

Fabrication and characterization of antimicrobial biopolymer films containing essential oil-loaded microemulsions or nanoemulsions

New active packaging materials were prepared consisting of biopolymer films containing the antimicrobial self-microemulsifying (SME) essential oil formulations or nanoemulsion. All the biopolymer films were constructed using calcium alginate to form a gel network with propylene glycol as a plasticizer. A mixture of essential oil (thyme oil), organic acids (acetic or propionic acid), and non-ionic surfactant (Tween®80) was used to formulate the antimicrobial microemulsion-films. The microemulsion-films were transparent, had little color, and were mechanically as strong but more stretchable than the control films (calcium-alginate only). Microstructural analysis showed that the microemulsion-films had high internal porosity and surface roughness, which resulted in an elevated water vapor permeability, opacity, and wettability. No new molecular interactions were detected in the films after incorporation of the essential oil using FTIR spectral analysis. The thyme oil was completely released from the microemulsion-films while only 3% of thyme oil was released from the nanoemulsion film when the films were brought into contact with water. Dynamic light scattering showed that the mean diameter of the oil droplets released from the microemulsion-films formulated from acetic or propionic acid were 38 and 28 nm, respectively. An antimicrobial assay showed that the highest microbial inhibition zones were obtained for the microemulsion-films. When applied to ground meat, the antimicrobial efficiency of the microemulsion-films was much higher than that of the control films against coliforms, Staphylococcus aureus, yeast, mold, and lactic acid bacteria. Our results demonstrate the efficiency of self-microemulsifying thyme oil films for maintaining the microbial quality of ground meat.

FORMULATION AND EVALUATION OF SOLID SELF MICRO EMULSIFYING DISPERSIBLE TABLET OF PIROXICAM

Objective: The aim of this study was to formulate the solid self-micro emulsifying dispersible tablets for promoting the dissolution of Piroxicam.
 Methods: Solubility study test was performed to know the solubility of various oil phase, surfactants, cosurfactants. Self-emulsifying grading test was done by visual grading system. Ternary phase diagrams and droplet size analysis test were performed to screen and optimize the Piroxicam-self microemulsifying drug delivery system (SMEDS). Then microcrystalline cellulose (KG802) was added as a suitable adsorbent and dispersible tablet were prepared by wet granulation compression method.
 Results: The final composition of Piroxicam-SMEDS was oil phase (oleic acid, 23%), surfactant (Cremophor R H-40,61%), co-surfactant (PEG-400,16%) based on the result of solubility test, self-emulsifying grading test, droplet size analysis and ternary phase diagrams. Microcrystalline cellulose (KG802) was selected based on dissolution study (98.35%) and added to liquid Piroxicam-Smeds formulation to form dispersible tablets. The in vitro dissolution study showed 98.02 % of drug release from Piroxicam-SMEDS tablets.
 Conclusion: Piroxicam–Self microemulsifying dispersible tablets have increased the solubility and bioavailability of the Piroxicam to a greater extent. SMEDS formulation can help the solubility of poorly water-soluble drugs.

MSc. Development of the In-house Specifications and Study of the Stability of Self-nanoemulsifying Drug Delivery System Containing Rosuvastatin

This study develops the in-house specifications of self-nanoemulsifying drug delivery system (SNEDDS) containing rosuvastatin based on the following criteria: description, identification, droplet size (≤200 nm) and polydiversity index (not more than 0.3), drug proportion in the oil phase (≥ 90.0%), assay (≥ 95.0% and ≤105.0% of the labeled amount of rosuvastatin (C22H28FN3O6S). The criteria were validated and the results were suitable for identification and determination of rosuvastatin in SNEDDS. Additionally, the results of the stability study show that the rosuvastatin SNEDDS met the criteria of description, droplet size, PDI, assay and drug rate in the oil phase for 12-month storage under the long-term condition (12 months) and 6 months on accelerated condition.
 Keywords
 Rosuvastatin, SNEDDS, specification, droplet size, entrapment efficiency.
 References
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Self-micro Emulsifying Drug Delivery System “SMEDDS” for Efficient Oral Delivery of Andrographolide

Objective: Andrographolide has potent anticancer and antimicrobial activity; however, its clinical application has been limited due to its poor water solubility as well as lack of appropriate formulation. The objective of this investigation was to formulate Self–Micro Emulsifying Drug Delivery System (SMEDDS) of andrographolide and explore its oral drug delivery aptitudes. Methods: Andrographolide SMEDDS was optimized by ternary phase approach and studied for various in vitro characteristics: Particle size, electron microscopy, polydispersity index, surface charge, dilution effect, pH stability, freeze-thaw effect, dissolution profile and stability studies. Further, antimicrobial and cytotoxic performance of andrographolide SMEDDS were evaluated in MCF–7 breast cancer cell lines and methicillin-resistant microorganisms, respectively. Results: An optimized SMEDDS formulation of andrographolide was successfully prepared and evaluated for its drug delivery potential. The solubility of andrographolide in the developed SMEDDS formulation was increased significantly, and the drug loading was enough for making this drug clinically applicable. The andrographolide SMEDDS formulation competitively inhibited the growth of microorganisms and showed enhanced anti–microbial activity against MRSA microorganisms. Conclusion: The SMEDDS strategy represents one of the best approaches to deliver andrographolide via oral route, while resolving its solubility limitations.

An Outlook for a Novel Approach: Self-Micro Emulsifying Drug Delivery System (SMEDDS)

Self-micro emulsifying drug delivery system (SMEDDS) has been one of the exclusive approaches to improve solubility and increase bioavailability for the poorly aqueous soluble drug. Due to microstructural features of active entity and formulation as a whole, vigorous researches are being carried to explore the significance and possibility of this drug delivery system at present. SMEDDS is an isotropic mixture of oil, surfactant, cosurfactant and water which involves encapsulation of drug into the lipid base and the formulation as a whole have unique ability to form fine o/w emulsion upon gentle agitation. The whole emulsification process requires only little entropy change which is obtained from the peristaltic motion of gut. Due to microstructural features of active entity and formulation as a whole provided by this approach, vigorous researches are being done at present time to interrelate the in vitro results obtained with in vivo responses. Considering the fact that 40% of the newly discovered drugs are lipophilic in nature, it signifies that the study in this approach will continue and more commercial formulation will be made available in near future. This review gives an overview on SMEDDS with sequential demystification thus enabling a greater understanding of their present role in medicine and drug delivery.

Enhanced Oral Bioavailability and Anticoagulant Activity of Dabigatran Etexilate by Self-Micro Emulsifying Drug Delivery System: Systematic Development, In vitro, Ex vivo and In vivo Evaluation

Dabigatran etexilate (DE), a prodrug of Dabigatran, is a potent, oral, reversible and direct thrombin inhibitor with low oral bioavailability due to active efflux by intestinal P-glycoprotein receptors. No lipid based oral formulation is marketed for DE till date. Hence, we formulated and evaluated self-micro emulsifying drug delivery system (SMEDDS), by using P-gp modulator excipients to tackle this issue and elevate the systemic availability of DE. The SMEDDS were developed using Capmul MCM C8, Cremophor EL and Transcutol HP as oil, surfactant and co-surfactant respectively. The formulation was optimized using statistical D-optimal design. The globule size of 73.24 nm with 0.085 PDI was achieved upon spontaneous emulsification with >99% Transmittance at 250 times dilution and discrete globules were observed under TEM. The in vitro and ex vivo drug release from DE-SMEDDS was found to be significantly higher in comparison to that from plain drug suspension. The DE-SMEDDS was observed to be non-cytotoxic and safe when assessed by MTT assay on Caco-2 cells. Moreover, a deeper penetration in the Caco-2 cells was observed with DE-SMEDDS when assessed using confocal laser scanning microscopy. Flow-cytometric studies also revealed greater uptake of fluorescent probe in Caco-2 cell-lines from the DE-SMEDDS when compared with drug suspension. Furthermore, the AUC0→t of DE from the optimized DE-SMEDDS formulation was found to be 2.5 times higher and relative bioavailability was enhanced by 3.36 folds than that from drug suspension on oral administration to rats. Moreover, DE SMEDDS exhibited higher anticoagulant activity than drug suspension, further indicating better bioavailability.

Self Microemulsifying Drug Delivery System (SMEDDS): A Novel Approach to Improve the Therapeutic Efficacy of Orally Administered Drug

The oral route is most preferred one as there is ease of administration and it is a painless approach. This favored route is restricted to those drug molecules that are absorbent over gastric mucosa. One of the promising techniques is SMEDDS. Self-micro emulsifying drug delivery system has gained more attention due to enhanced oral bioavailability enabling a reduction in dose, more consistent temporal profiles of drug absorption, selective targeting of drug towards specific absorption window in GIT, and protection of drugs from the unreceptive environment in the gut. SMEDDS provide the dissolved drugs form, and also its small size of droplets imparts substantial interfacial area for the absorption of drugs. It can simply get penetrated into the GIT which is the major advantages over another emulsion. The present study is performed for the motivation of the graduates towards publication and research. Hence, we have encouraged the graduates to prepare an informative article on the present subject

Improving oral bioavailability of resveratrol by a UDP-glucuronosyltransferase inhibitory excipient-based self-microemulsion

Self-microemulsifying (SME) drug delivery system has been developed to increase oral bioavailabilities, and inhibitory excipients are capable of improving oral bioavailability by inhibiting enzyme mediated intestinal metabolism. However, the potential of enzyme inhibitory excipients containing SME in boosting resveratrol bioavailability remains largely uninvestigated. In this study, we set out to prepare SME-1 with UGT inhibitory excipients (excipients without inhibitory activities named SME-2 as control) to increase the bioavailability of RES by inhibiting intestinal metabolism. Results demonstrated that similar physicochemical properties such as size, polydistribution index and in vitro release, cellular uptake and permeability in Caco-2 cells as well as in vivo lymphatic distribution between inhibitory SME-1 and non-inhibitory SME-2 were observed. In vivo study demonstrated that the molar ratios of RES-G/RES were 7.25±0.48 and 5.06±2.42 for free drug and SME-2, respectively, and the molar ratio decreased to 0.36±0.10 in SME-1 group. Pharmacokinetic study confirmed that the inhibitory excipients containing SME demonstrated potential in increasing bioavailability of RES from 6.5% for the free RES and 12.9% for SME-2 to 76.1% in SME-1 through modulating the glucuronidation by UGT inhibitory excipients.

Self microemulsifying formulation of Lagerstroemia speciosa against chemically induced hepatotoxicity

Self microemulsifying formulation is an approach used for enhancing the bioavailability of poorly soluble molecules due to their lipidic nature and small particle size. The objective of the present study was to evaluate the hepatoprotective activity of poorly soluble hydroxy- and polyhydroxy-organic phytomolecules rich Lagerstroemia speciosa leaves extract in modern formulation i.e. “Self microemulsifying System”.Different doses of SME (Self microemulsifying) formulation of L. speciosa leaves extract were evaluated for the hepatoprotective activity against carbon tetrachloride induced liver toxicity in rats. The parameters evaluated were (a) biochemical parameters like serum enzymes: aspartate aminotransferase (AST), serum glutamate pyruvate transaminase (ALT), serum alkaline phosphatase (ALP) and total bilirubin (b) liver antioxidant parameters as estimation of Lipid peroxidation (LPO), catalase (CAT), Superoxide dismutase (SOD) activity and concentration of reduced glutathione (GSH). Oral administration of SME formulation provided the significant protection in marker enzyme of treated group at 100 mg/kg, p.o. as AST (P < 0.001), ALT (P < 0.001), ALP (P < 0.001) and total bilirubin (P < 0.001) comparable to the group treated with silymarin. Treatment with SME formulation at the doses of 100 mg/kg, p.o. significantly prevented the rise in levels of LPO significantly (P < 0.001). The GSH, SOD and CAT contents had significantly (P < 0.001) increased in SME formulation treated groups whereas carbon tetrachloride intoxicated group had shown significant decrease in these parameters compared to control group. Formulation at the dose 100 mg/kg, p.o. has shown maximum protection which was almost comparable to those of the normal control and standard. The histological observations further uphold the results for hepatoprotective activity.

Review on the formulation considerations needed to produce a stable Self micro Emulsifying Drug Delivery System (SMEDDS)

Ease of administration and painless approach made oral route the most preferred. Poor oral bioavailability is pronounced with the majority of recent active ingredients because of dissolution rate limited absorption. Failure to attain intended therapeutic effect of the poor water soluble drugs by this route led to development of novel drug delivery systems which will fulfill therapeutic needs with minimum dose. Although many formulation approaches like solid dispersions, complexation, pH modifications and lipid based delivery systems finding increased appliance with the apparent increase in absorption of drug. Among lipid based formulations, self-micro emulsifying formulations (droplet size < 100 nm) are evident to improve the oral bioavailability of hydrophobic drugs primarily due to their efficiency in facilitating solubilization and in presenting the hydrophobic drug in solubilized form whereby dissolution process can be circumvented. Various components that are used to formulate these dosage forms like surfactants and lipids contribute to the overall improvement in oral bioavailability via promoting the lymphatic transport; thereby hepatic first pass metabolism can be surmounted. The present article gives exhaustive information on the formulation design and characterization of SMEDDS by which the bioavailability can be improved. In this review article, the various aspects of pharmaceutical SMEDDS where compiled together and target audience are specifically the B. Pharm and M. Pharm students so that their knowledge towards the subject concern can be enhanced and also at the same time can be motivated towards the publication.

Self-Micro Emulsifying Drug Delivery Systems: A Strategy to Improve Oral Bioavailability

Aim: Oral route has always been the favorite route of drug administration in many diseases and till today it is the first way investigated in the development of new dosage forms. The major problem in oral drug formulations is low and erratic bioavailability, which mainly results from poor aqueous solubility, thereby pose problems in their formulation. For the therapeutic delivery of lipophilic active moieties (BCS class II drugs), lipid based formulations are inviting increasing attention. Methods: To that aim, from the web sites of PubMed, HCAplus, Thomson, and Registry were used as the main sources to perform the search for the most significant research articles published on the subject. The information was then carefully analyzed, highlighting the most important results in the formulation and development of self-micro emulsifying drug delivery systems as well as its therapeutic activity. Results: Self-emulsifying drug delivery system (SMEDDS) has gained more attention due to enhanced oral bio-availability enabling reduction in dose, more consistent temporal profiles of drug absorption, selective targeting of drug(s) toward specific absorption window in GIT, and protection of drug(s) from the unreceptive environment in gut. Conclusions: This article gives a complete overview of SMEDDS as a promising approach to effectively deal with the problem of poorly soluble molecules.

Self-Micro Emulsifying Drug Delivery System: An Approach for Enhancement of Bioavailability of Poorly Water Soluble Drugs

The improvement of oral bioavailability of poorly water soluble drug can be considered as one of the greatest challenges in drug formulation. In recent years today, up to 90% of all new chemical entities entering drug development programs possess insufficient aqueous solubility which leads to poor bioavailability, high intra and inter subject variability, lack of dose, gastric and enzymatic degradation of drug. To overcome these problems, various formulation strategies have been developed e.g. (use of surfactants, lipids, permeation enhancers, micronization, salt formulation, cyclodextrins, nanoparticles and solid dispersion) and different technologies of drug delivery system, but SMEDDS is gaining more attention for improving the solubility of lipophilic drug. The present review examine the advances in solid (S-SMEDDS) with regards to the selection of lipid system for current formulation and advantages of SMEDDS over emulsion, difference and similarities between SEDDS and SMEDDS, SMEDDS formulation, excipients and their characteristic, solidification techniques, dosage form of SMEDDS, evaluation of SMEDDS, example of some marketed product.

Enhanced oral bioavailability of felodipine by novel solid self-microemulsifying tablets

The novel self-microemulsifying (SME) tablets were developed to enhance the oral bioavailability of a poor water-soluble drug felodipine (FDP). Firstly, FDP was dissolved in the optimized liquid self-microemusifying drug delivery systems (SMEDDS) containing Miglyol® 812, Cremophor® RH 40, Tween 80 and Transcutol® P, and the mixture was solidified with porous silicon dioxide and crospovidone as adsorbents. Then after combining the solidified powders with other excipients, the solid SME tablets were prepared by wet granulation–compression method. The prepared tablets possessed satisfactory characterization; the droplet size of the SME tablets following self-emulsification in water was nearly equivalent to the liquid SMEDDS (68.4 ± 14.0 and 64.4 ± 12.0 nm); differential scanning calorimetry (DSC) and powder X-ray diffractometry (PXRD) analysis demonstrated that FDP in SME tablets had undergone a polymorphism transition from a crystal form to an amorphous state, which was further confirmed by transmission electron microscopy (TEM). A similar dissolution performance of SME tablets and liquid SMEDDS was also obtained under the sink condition (85% within 10 min), both significantly higher than commercial tablets. The oral bioavailability was evaluated for the SME tablets, liquid SMEDDS and commercial conventional tablets in the fasted beagle dogs. The AUC of FDP from the SME tablets was about 2-fold greater than that of conventional tablets, but no significant difference was found when compared with the liquid SMEDDS. Accordingly, these preliminary results suggest that this formulation approach offers a useful large-scale producing method to prepare the solid SME tablets from the liquid SMEDDS for oral bioavailability equivalent enhancement of poorly soluble FDP.