SR Tablets Research Articles

In-vivo Pharmacokinetic Evaluation of Venlafaxine HCl Sustained Release Tablet Formulation.

An optimized Venlafaxine SR tablets formulation, was chosen for in‐vivo study against the commercial marketed Venlafaxine SR formulation. The non-compartmental pharmacokinetic specifications of both reference and standard were determined, after dosing via oral route. The peak plasma concentration (Cmax) of optimized Venlafaxine SR tablets was found as 964.66 ± 53.15ng/ml in 5 hr, while Cmax of marketed Venlafaxine SR tablets formulation was found as 872.33 ± 28.43 ng/ml in same time i.e. 5 hr. The Cmax data suggests that absorption of drug in plasma from was in sustained manner from both the formulations, showing typical absorption pattern of SR product. The AUC0-t for optimized and marketed Venlafaxine SR tablets was found to be 12981.63 ± 505.25 and 12023.83 ± 668.29 ng/ml*h, while AUC0-∞ was found to be 13921.51 ± 417.40 and 13099.63 ± 742.21 ng/ml*h, respectively. The PK parameter showed the Tmax and AUC for optimized Venlafaxine SR tablets as compared to its marketed product formulation. Pharmacokinetic parameter clearly suggested prolong release and availability of Venlafaxine in plasma from SR tablets formulation. Overall, the results suggest that the optimized SR formulation of Venlafaxine provides effective extended and controlled drug delivery, highlighting its potential clinical relevance in the treatment of depression and anxiety disorders.

사포그릴레이트 염산염을 함유하는 신규 OROS 정의 제제 설계 및 용출 거동

Sarpogrelate hydrochloride (SGH) is a drug that improves ischemic symptoms such as ulcers, pain, and feeling of cold caused by chronic arterial occlusion, and has a short half-life of 0.6 to 0.8 hours. Also, reference drug (SarpodipilⓇ SR tablet) is affected by drug release depending on pH. To overcome this, the osmotic controlled release oral delivery system (OROS) utilizes push-pull osmotic pump (PPOP) technology that can achieve zero-order drug release over 24 hours by osmotic pressure. OROS tablet is double-layer tablet consisting of a drug layer (L200-PEO) and a push layer (H5,000- PEO). OROS tablet coated with a semi-permeable film has a orifice of a certain size made by a laser drill, so that the drug is released at a constant rate. The dissolution of the OROS tablet was not affected by the amount of sodium chloride in the drug layer and the number of orifice, but was affected by amount of coating, cellulose acetate (CA) : polyethylene glycol 3350 (PEG 3350) ratio and the size of orifice. Accordingly, as the amount of coating increased and PEG 3350 decreased, the dissolution rate decreased. The developed OROS tablet (formulation C), unlike the reference drug, is not affected by pH, showing high similarity factors of 76.0, 86.1, and 91.2 at pH 1.2, pH 4.0, and pH 6.8 when compared to distilled water. In conclusion, we developed OROS tablet containing SGH, showing zero-order release that continuously releases the drug for 24 hours regardless of pH, and confirmed the factors affecting dissolution.

Design and Development of Multiparticulate Mini Tablets of Verapamil Hydrochloride for Pulsatile Drug Delivery

Abstract: Objectives: The objective of the research was to develop and evaluate the multiparticulate pulsatile release minitablets of verapamil hydrochloride for the treatment of hypertension at a desired time to mimic the circadian rhythms and improve the patient compliance. Materials and Methods: Formulation was prepared by CODAS technology. It was designed to initiate the release of verapamil after 4h lag time and reached the therapeutic levels at in the early morning hours, when the blood pressure is at its highest. The core minitablets were prepared by wet granulation process and coated with water insoluble polymer like ethylcellulose along with hydrophilic plasticizer. The formulation attributes were optimized and evaluated the in vitro performance. Results: The in vitro dissolution studies revealed that the coating build-up of ethylcellulose controls the initial lag time and release rate of drug product. Among the formulations (F1a) 10% w/w ethylcellulose coated minitablets showed lag time for 4 hr and controlled the release up to 24 hr. The formulation optimization studies illumined the critical attributes like fumaric acid (F2), which modified the microenvironment and improved the dissolution profile of drug product in phosphate buffer. The optimized formulation (F1a) was compared against the marketed product (CALAPTIN 120 mg SR tablets) and observed that the dissolution behaviour of the drug product followed first-order kinetics. Conclusion: The outcomes were presumed that the pulsatile release has been accomplished from coated minitablets with a lag time of 4hr, which is reliable with the demands of the chronotherapeutic drug delivery by efficiently control the blood pressure at early morning. Keywords: Multiparticulates, Pulsatile release minitablets, Verapamil hydrochloride, Chronotherapeutic drug delivery, Fumaric acid, ethylcellulose.

Formulation and Evaluation of Metformin Hydrochloride Sustained Release Tablet

Metformin hydrochloride (MET) is an oral hypoglycemic agent which improves glucose tolerance in patients with type 2 diabetes and diminishes basal plasma levels of glucose. The aim of this study was to develop and optimize MET matrix tablets for SR application. The SR matrix tablet of MET was prepared by wet granulation technique using Polyvinyl pyrrolidone K30 and hydroxyl propyl methylcellulose of different viscosity grades (HPMC K4M, HPMC K15M, and HPMC K100M). The influence of varying the polymer ratios was evaluated. The excipients used in this study did not modify physicochemical properties of the drug. MET has relatively short plasma half-life, low absolute bioavailability. The need for the administration 2 to 3 times a day when larger doses are required can decrease patient fulfillment. SR formulation that would maintain plasma level for 8-12 h might be sufficient for daily dosing of MET. SR products are needed for MET to prolong its duration of action and to improve patient compliances. The development of oral sustained release systems has been a challenge to formulation scientists due to their inability to restrain and localize the system at targeted areas of the gastrointestinal tract. From all the formulation trial batches, formulation F3 shows the best results. It has been observed that HPMC K100M alone cannot give satisfactory drug release profile but the blend of HPMC K100M and Polyvinyl pyrrolidone K30 together give the best drug release kinetics. Thus, sustained release matrix tablets of metformin hydrochloride can be expected to reduce the frequency of administration and decrease the dose dependent side effects. Keywords: Metformin hydrochloride, SR matrix tablet, HPMC K100M, Wet granulation technique

Stable Solid Dispersion Incorporated Sustained Release Oral Gel of 23 mg Donepezil Hcl

The objective of the present study is to formulate and evaluate stable solid dispersion incorporated sustained release oral gel of donepezil Hcl. Solid dispersions were prepared using HPMC K100M and stearic acid using physical mixture, co-grinding and fusion methods and incorporated into the previously prepared gel bases using sodium CMC and sodium alginate and suitable formulation was optimised. All the formulations were subjected to physicochemical evaluation parameters. Solid dispersions of donepezil were prepared with HPMC K100 and stearic acid by using different methods like physical mixtures, co grinding and fusion method in the ratios of 1:1, 1:2 and 1:3. From the invitro dissolution studies, it was found that SD made by co grinding and fusion method showed sustained release and were selected and incorporated into the gel formulations made of SCMC 4% and sodium alginate 4%. The release studies of solid dispersion incorporated gel SD-HPMC K100M showed (SDG1) 87.55% and (SDG2) 88.9% at 8th hour and SD-stearic acid showed (SDG3) 83.26% and (SDG4) 82.57% at 8th hour. It was concluded that stearic acid solid dispersions incorporated in sodium CMC gels (SDG3) were optimised using short term stability studies with no leakage of drug in comparison to solid dispersions of HPMC K100M in sodium CMC gel l. Physico-chemical evaluation parameters were carried out for optimised formulations and found to be within limits. The optimized SD incorporated gel formulation of donepezil can be an alternative to SR tablet in improving the compliance of the geriatric patients.

Polymer Change Approach for Formulation of Aceclofenac Sustained Release Tablet

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) analog of diclofenac. Aceclofenac works by inhibiting the action of cyclooxygenase (COX) that is involved in the production of prostaglandins (PG) which is accountable for pain, swelling, inflammation and fever. Modified drug delivery system has been used to improve the drug absorption and bioavailability. Sustained release tablet of Aceclofenac has been prepared with the help of different polymers for better results. In this review article, a new approach has been studied for the formulation of sustained release tablet of Aceclofenac by changing the polymers. Different polymers has been studied for the formulation of Aceclofenac SR tablet which shows better absorption and improved bioavailability. This suggests that marketed formulations of Aceclofenac tablet should be prepared and evaluated with this new approach for better results.

Formulation and Evaluation of Indapamide Hemihydrate Sustained Release Tablets

The aim of the study is to formulate and to evaluate the indapamide SR tablet for the treatment of hypertension. Literature survey shows that indapamide is an anti-hypertensive and diuretic drug. The drug has been released up to 6–15 h, after taken orally. These tablets are absorbed into the systemic circulation and blood level shows the considerable peak of drug. It has been formulated as sustained release form for the betterment of therapeutic index and for maintaining constant blood levels. From the study, it has been concluded that HPMC shows the best results for the extending the release of drug. Wet granulation method is used for the preparation of these tablets. The compatibility study for optimized formulation shows satisfactory results. The evaluation of tablets was done for the hardness, friability, weight variation, thickness, drug content, in vitro buoyancy study, swelling index, in vitro dissolution studies, and stability study.

Formulation Development and Characterization of Darunavir and Ritonavir Sustained Release Tablets Using Quality by Design Approach

Darunavir is a nonpeptidic inhibitor of protease and is primarily metabolized by cytochrome P450 3A (CYP3A) isoenzymes. It is usually coadministered with low-dose ritonavir (Darunavir/r). Ritonavir is an inhibitor of CYP3A isoenzymes and pharmacologically enhances Darunavir which leads to increased plasma concentrations of darunavir and allows for daily lower dose. Here, we have developed combination SR formulation of Darunavir and Ritonavir and evaluated. In vitro drug release of all formulations was carried out in dissolution medium 900ml of pH 3.0, 0.05 M Sodium Phosphate Buffer + 2% Tween 20 for 75 RPM USP II apparatus (paddle). The results shown that, all the formulations of matrix tablets shown the good release of drug from trialed formulations however all formulations were not releasing the drug in enough amount. In matrix tablets F6, the release of drug shows NLT 80%. So, the formulation F6 have been considered as suitable for the SR tablet of Darunavir and Ritonavir. Tablets were also evaluated though Quality by Design (QbD) method.

Formulation, Development and Evaluation of Bilayer Floating Tablets of Antihypertensive Drug Bosentan

Hypertension, or high blood pressure, is a major public health concern around the world because of its large contribution to the global health burden and its function as a major risk factor for a variety of disease processes. Bosentan SR Floating Bilayer Tablets were made with HPMC K4M, HPMC E-15, and HPMC E-15 alone (80%) and in combination with varying percentages of polymer (20&60 percent, 40&40 percent, and 60&20 percent ). The hydrophilic polymer HPMC is used to make three different formulations (M4, M8, and M12) of floating Bosentan SR tablets, each with a viscosity grade of 80 percent. M12 formulation was shown to be suitable for SR tablet formulation. From the M12 formulation. It's based on the M12 formula. The fraction of high viscosity polymer can be lowered by adding low viscosity polymer, as demonstrated in the C3 formulation. It was clear from the dissolution profile of formulation C3 that by mixing the low and high viscosity polymers, the drug release from the formulation may be improved as compared to manufacturing M12 high viscosity polymer alone. According to the findings of this investigation, as floating duration increases, the release rate drops. As a result, it's appropriate for long-term formulation.
 Keywords: Bosentan, Floating Bilayer Tablets, Hypertension, SR Tablets, HPMC K4M, E-15

FORMULATION, EVALUATION AND OPTIMIZATION OF SUSTAINED-RELEASE DRUG DELIVERY SYSTEM OF CISAPRIDE TABLET

Objective: Cisapride is a novel prokinetic agent is best candidate for GERD. Cisapride 20 mg can be given thrice in a day given along with Proton pump inhibitor. By developing the sustain release formulation of Cisapride, the frequency of both drug can be reduce to once only to obtain good therapeutic response. Methods: Cisapride SR Tablets were prepared by direct compression technique with HPMC K4M and HPMC K100M polymers. Followed by various evaluation tests including in vitro disintegration and dissolution, the formulation was optimized by 32 full factorial designs with drug release kinetic analysis, compatibility studies (FTIR) and stability studies. Results: Results of Preformulation studies of the Cisapride indicate that it has poor flow property and compressibility property. To improve the flow and compressibility property, it was beneficial to use the directly compressible grade components in the formulation of tablet. Results of DSC study shown that there is no change in drug’s melting peak after the preparation of tablet. Hydrophilic matrix of HPMC K4M and HPMC K100M in combination sustained the Cisapride release effectively for more than 12h. The result indicates that the combination of HPMCK4M and HPMCK100M can be successfully, On the basis of the preliminary trials in the present study a32 full factorial design was employed to study the effect of independent variables, i.e. concentration of HPMCK4M(X1) and concentration of HPMCK100M(X2)on dependent variables like% drug release Q2, Q6 and Q10. Drug release is also dependent on the size of matrix tablets so, size and surface area was kept constant. Factorial batches F018, F019, F020, and F021 give the f2 value 75-100. Factorial batch F019 gives the highest f2 value 86.04 and also all the hour’s drug release was within the specified limits. Conclusion: The prepared formulation of Cisapride sustains release matrix tablet was stable and effective in treatment.

Formulation Development and Characterization of Darunavir and Ritonavir Sustained Release Tablets using Quality by Design Approach

Darunavir is a nonpeptidic inhibitor of protease and is primarily metabolized by cytochrome P450 3A (CYP3A) isoenzymes. It is usually coadministered with low-dose ritonavir (Darunavir/r). Ritonavir is an inhibitor of CYP3A isoenzymes and pharmacologically enhances Darunavir which leads to increased plasma concentrations of darunavir and allows for daily lower dose. Here, we have developed combination SR formulation of Darunavir and Ritonavir and evaluated. In vitro drug release of all formulations was carried out in dissolution medium 900ml of pH 3.0, 0.05 M Sodium Phosphate Buffer + 2% Tween 20 for 75 RPM USP II apparatus (paddle). The results shown that, all the formulations of matrix tablets shown the good release of drug from trialed formulations however all formulations were not releasing the drug in enough amount. In matrix tablets F6, the release of drug shows NLT 80%. So, the formulation F6 have been considered as suitable for the SR tablet of Darunavir and Ritonavir. Tablets were also evaluated though Quality by Design (QbD) method.

Study of the cost variation analysis of anti-epileptic drugs available in different brands in Indian pharmaceutical market

Background: The aim of this study was to analyze the cost ratio and percentage cost variations in different brands of the commonly prescribed anti-epileptic drugs available in Indian pharmaceutical market.Methods: The maximum and minimum price of each brand of the drug given in Indian rupees (INR) was noted by using CIMS January to April 2020 edition and drug today April to June 2020 volume 1. The cost ratio and the percentage cost variation for individual drug brands was calculated. The cost of one bottle in case of 100 ml syrup and 10 tablets/capsules was calculated in case of oral drugs and the cost of one 1 vial or ampoule was noted in case of injectable drugs. At last the cost ratio and percentage cost variation of various brands was compared.Results: After calculation of cost ratio and percentage cost variation for each brand of anti-epileptic drug tablet clonazepam (2 mg) shows highest cost ratio and percentage cost variation as 10.41 and 941.66, carbamazepine (200 mg SR tablet) shows lowest cost ratio and percentage cost variation as 1.09 and 9.32.Conclusions: Epilepsy is the most common neurological disorder and epileptic drugs are to be prescribed for prolonged period. If a costly brand is prescribed, the patients have to pay more money unnecessarily for their treatment. There is a wide difference in the cost of different brands of anti-epileptic drugs available in India. The clinicians prescribing these drugs should be aware of these variations in cost to reduce the cost of drug therapy.

Development of a Population Pharmacokinetics-Based in vitro-in vivo Correlation Model for Drugs with Site-Dependent Absorption: the Acyclovir Case Study.

Acyclovir is a Biopharmaceutics Classification System (BCS) class III antiviral agent which is only absorbed in the upper part of the gastrointestinal tract. This study aimed to establish a new in vitro-in vivo correlation (IVIVC) platform based on population pharmacokinetic modeling for drugs with site-dependent absorption using acyclovir as a model drug. Three types of sustained-release (SR; 500mg) acyclovir tablets were prepared by the wet granulation method. The in vitro dissolution profiles of the acyclovir SR tablets and the immediate-release (IR; 200mg) were determined by the paddle method and their in vivo pharmacokinetics were evaluated in Beagle dogs. A population pharmacokinetic model was developed using S-ADAPT. By separating the dissolution and absorption processes, the population pharmacokinetic model adequately described all the in vivo pharmacokinetic data and estimated the in vivo dissolution profiles. The changes of absorption rate over time after oral administration were also successfully estimated. The parameter estimates of the in vitro and in vivo drug releases were correlated by linear regression. Finally, the in vivo pharmacokinetic profiles were well predicted by the developed IVIVC model from the in vitro dissolution data with the prediction errors within 8.26% and 10.06% for the maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC), respectively. The present approach provides a better understanding of the in vivo absorption for drugs that have limited absorption window and may be useful for their new formulation design and development.

Preparation and in vitro and in vivo Evaluation of Chitosan-Gliclazide Mucoadhesive Microparticles by an Emulsification- Desolvation- Crosslinking Technique

Abstract: Introduction: Recently much emphasis is being laid on the development of microparticles because of their potential benefits such as increased bioavailability, reduced risk of systemic toxicity, reduced risk of local irritation and predictable gastric emptying. Objective: The objective of the present study is to prepare and evaluate mucoadhesive microparticles of chitosan-gliclazide for oral controlled release. Methods: A new method namely emulsification-desolvation-crosslinking was used for the preparation of chitosangliclazide microparticles and the microparticles were evaluated by in vitro and in vivo methods. Results: Spherical chitosan-gliclazide microparticles could be prepared by the emulsification-desolvation-crosslinking method. The method was reproducible with regard to size and size distribution of the microparticles. The chitosan-gliclazide microparticles exhibited good muoadhesive property. Gliclazide release from the chitosan microparticles was slow and extended over longer periods of time and depended on the proportion of core: coat. Gliclazide release from the chitosan microparticles was by diffusion mechanism. Microparticles (F3) prepared using a core: coat ratio of 8:2 gave slow and controlled release of gliclazide over 12 h similar to that of commercial gliclazide SR tablets. In the in vivo evaluation, the gliclazide microparticles (F3) gave a slower reduction in serum glucose levels and the reduced glucose levels were sustained over longer periods of time. Conclusion: Microparticles (F3) are considered as a promising microparticulate drug delivery system for oral controlled release of gliclazide over 12 h for b.i.d administration. Key words: Mucoadhesive microparticles, Chitosan, Gliclazide, Emulsification-desolvationcrosslinking method, Oral controlled release.

Acrylamide grafted neem (Azadirachta indica) gum polymer: Screening and exploration as a drug release retardant for tablet formulation

The study was initiated with the intent to synthesize acrylamide grafted neem gum polymer (AAm-g-NG), and screen its drug release retardation ability both in vitro and in vivo. Different batches (NGP-1 to NGP-9) of tablet formulation were prepared by varying polymer concentration using propranolol HCl and compared with HPMC K100 M and marketed SR tablets. FTIR study proved the grafting phenomenon and showed no incompatibility between AAm-g-NG and propranolol HCl. AAm-g-NG showed significant swelling and water retention capacity than NG. AAm-g-NG was found to be biodegradable and exhibited no toxicity to Artemia salina. After 12 h, NGP-6 showed non-significant (p > 0.05; f2= ∼ 90) percent drug release (80.52 ± 3.41%) compare to marketed formulation (79.65 ± 4.08%). Significant swelling of the matrix caused slower diffusion of the drug. NGP-6 and marketed formulation in rabbits showed the non-significant difference between Cmax and Tmax, hence NGP-6 meets the requirement of sustained-release tablets.

Formulation and Evaluation of SR Tablets of Anti-diabetic drug Gliclazide

Formulation and Evaluation of SR Tablets of Anti-diabetic drug Gliclazide

Do fish oil supplements benefit people with hypertension? Results from the 45 and Up Study

The paper presents a case of fatal intoxication after massive sustained-release clomipramine overdosage with prolonged toxicity related to a large gastric pharmacobezoar. 42-year-old female was admitted to the toxicology unit 14 h after drugs ingestion. At admission patient was deeply unconscious, required controlled mechanical ventilation. Serum total level of TCAs was 1955 ng/mL. Gastric lavage revealed no pills. Within the next 12 h the patient's clinical condition improved. TCAs level decreased to 999 ng/mL. However, after another 10 h the clinical condition started deteriorating again and the patient went into a deep coma requiring controlled mechanical ventilation. TCAs level increased to 2011 ng/mL. X-ray and computed tomography revealed large pharmacobezoar consisted from radio-opaque pills. In the 28th h of hospitalization gastrotomy was performed, confirming presence of pharmacobezoar formed from Anafranil SR tablets. After surgery TCAs level was gradually decreasing. However, the patient's condition did not improve, she died 32 h after gastrotomy. Post-mortem analyses revealed drug and its metabolite toxic levels in blood (clomipramine – 1729 ng/mL, norclomipramine – 431 ng/mL) and toxic levels in internal organs: myocardium (clomipramine – 14,420 ng/g, norclomipramine – 35,930 ng/g), vitreous humor (clomipramine – 1000 ng/mL, norclomipramine – 3110 ng/mL).Described case report indicates that sustained release clomipramine tablets may form pharmacobezoar. X-ray and computed tomography examinations should be considered in cases of massive abuse of sustained release clomipramine, particularly if symptoms of intoxication are recurrent or persistent.

Formulation Development and Evaluation of Rosuvastatin Sustained Release Tablets

Purpose: The main objective of present research investigation is to formulate the sustained release formulation of Rosuvastatin. Rosuvastatin, an antihyperlipidemic agent, belongs BCS class-II agent.Methods: The SR tablets of Rosuvastatin were prepared employing different concentrations of HPMCK4M and SCMC in different combinations by Direct Compression using 32 factorial design. The concentration of Polymers , HPMCK4M and SCMC required to achieve the desired drug release was selected as independent variables, X1 and X2 respectively whereas, time required for 10% of drug dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables.Results and Discussion: Totally nine formulations were designed and are evaluated for hardness, friability, thickness, % drug content, In-vitro drug release. From the Results it was concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept, slope & regression coefficient were calculated. Polynomial equations were developed for dependent variables. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F4) containing 30 mg of HPMCK4M and 40 mg of SCMC, is the most similar formulation (similarity factor f2= 89.561, dissimilarity factor f1= 1.543 & No significant difference, t= 0.0056) to marketed product (CRESTOR).Conclusion: The selected formulation (F4) follows Zero order, Higuchi’s kinetics, and the mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.963).

Validation of Stability Indicating RP-HPLC, Method of Analysis for assay of Ivabradine HCl in SR Tablet

Validation of Stability Indicating RP-HPLC, Method of Analysis for assay of Ivabradine HCl in SR Tablet

Comparative phase I randomized open-label pilot clinical trial of Gynophilus\xae (Lcr regenerans\xae) immediate release capsules versus slow release muco-adhesive tablets

Gynophilus® (Lcr regenerans®) is a live biotherapeutic product (LBP) that contains the live biotherapeutic microorganism Lactobacillus rhamnosus Lcr35®, which is indicated to restore vaginal health. The aim of the study was to compare the safety, ease of use, and compliance of two formulations (immediate release: IR capsule and slow release: SR muco-adhesive tablets) as well as the colonization of Lcr35® in healthy women. This phase I study (Comprigel) is a parallel, randomized, 4-arm, and open-label clinical trial evaluating an IR daily capsule formulation vs. a SR tablet administered every 3, 4, or 5 days for 21 days. Self-collected vaginal swabs were used to quantify Lcr35® and characterize the composition and structure of the vaginal microbiota. Both LBPs were well-tolerated, and no severe adverse effects were reported. All groups had Lcr35® vaginal concentrations over 107 colony forming unit per milliliter of vaginal secretion on each day in the study. The new Gynophilus® slow release tablets administered either every 3, 4, or 5 days provided vaginal concentrations that were not significantly different from those of classic Gynophilus® (capsule) once-a-day regimen. The LBPs and the different regimens did not adversely influence the abundance of native Lactobacillus spp. and indeed tended to favor their growth and reduce colonization by non-Lactobacillus spp. This study illustrates that the SR muco-adhesive LBP tablet (Gynophilus® SR) administered every 3 or 4 days as a safe, well-tolerated, and efficacious alternative to a more demanding IR daily capsule and could protect women’s healthy vaginal microbiome by promoting endogenous Lactobacillus spp.