Taste Masking Agents Research Articles

An Overview of the Components, Techniques, and Innovation Used for Fast-Dissolving Films.

Fast-dissolving films (FDFs) stand as a cornerstone in modern pharmaceutical innovation, heralded for their unrivaled convenience, patient adherence, and the swift onset of action. Within the realm of this paper lies a meticulous exploration of FDFs, delving deep into their intricate formulation intricacies, manufacturing methodologies, and diverse therapeutic applications. The formulation journey traverses the meticulous selection of film-forming polymers, plasticizers, taste-masking agents, and active pharmaceutical ingredients (APIs), each element meticulously calibrated to achieve optimal efficacy. Diverse production techniques, spanning solvent casting, hot melt extrusion, and spray drying, are scrutinized with precision, shedding light on their inherent advantages and nuanced limitations. Beyond the realm of formulation and manufacturing, this review embarks on an expansive voyage into the vast therapeutic landscape that FDFs traverse. From the treatment areas of central nervous system disorders to the realms of cardiovascular diseases, allergies, and pain management, the versatility and adaptability of FDFs emerge as a beacon of hope for patients and practitioners alike. Yet, amidst the brilliance of FDFs, inherent challenges linger, from stability concerns to the intricate dance of bioavailability and the ever-watchful eye of regulatory scrutiny. However, within these challenges lies the fertile ground for future research and development endeavors, beckoning forth a new era of innovation and advancement in the realm of rapidly dissolving films. This study stands as an indispensable compass, guiding researchers, pharmaceutical scientists, and practitioners toward the forefront of FDF development and implementation.

Orodispersible Dosage Forms with Rhinacanthin-Rich Extract as a Convenient Formulation Dedicated to Pediatric Patients.

Rhinacanthins, derived from Rhinacanthus nasutus, widely used in traditional medicine, exhibit antifungal, anticancer, antiviral, antibacterial, and antiplatelet aggregation effects. Recently, their anti-diabetic activity was confirmed, which makes them an interesting natural alternative in the therapy of the early stage of diabetes mellitus. The aim of this study was to demonstrate the possibility of formulating orodispersible tablets (ODTs) and orodispersible films (ODFs) containing rhinacanthin-rich extract (RRE). Tablets with 50 mg or 100 mg of RRE were produced by direct compression. ODFs were manufactured by casting of Lycoat RS 720 or polyvinyl alcohol solution with RRE and additional excipients. The mechanical properties and disintegration times of the prepared formulations were studied. The effectiveness of taste masking was analyzed with an electronic tongue system. Six months simplified stability studies were performed in conditions complying to ICH guidelines. Appropriate friability of ODTs was achieved, despite low tensile strength (0.45-0.62 MPa). All prepared ODFs successfully met the acceptance criteria regarding Young's modulus, tensile strength, and elongation at break. The observed variations in their mechanical properties were dependent on the type and quantity of polymers and plasticizers used. Disintegration time of ODTs ranged from 38.7 s to 54.2 s, while for ODFs from 24.2 to 40 s in the pharmacopoeial apparatus. Analyses made with the electronic tongue showed the significant taste-masking effect in both formulations. The addition of sucralose as a sweetener and menthol with mint flavor as a taste-masking agent was sufficient to mask an RRE's taste in the case of ODTs and ODFs. Stability studies of ODTs packed in the PVC/Alu blisters showed a decrease in the RRE content below 90% after 6 months. However, ODFs with PVA were physicochemically stable for 6 months while being stored in Alu/Alu sachets. Our study proved for the first time the possibility of the formulation of orodispersible dosage forms with RRE, characterized by good mechanical properties, disintegration time, and appropriate taste masking.

Unleashing the Potential of β -cyclodextrin Inclusion Complexes in Bitter Taste Abatement: Development, Optimization and Evaluation of Taste Masked Anti-emetic Chewing Gum of Promethazine Hydrochloride.

Motion sickness also known as kinetosis is a condition in which there exists a disagreement between visually perceived movement and the vestibular system's sense of movement. Nausea, vomiting, dizziness, fatigue, and headache are the most common symptoms of motion sickness. This study mainly focuses on the taste masking of Promethazine Hydrochloride (PMZ) by inclusion complexation method, its formulation development in the chewing gum form by using directly compressible gum base HIG® and its quality and performance testing. Different molar ratios (1:1, 1:2, 1:3 and 1:4) of PMZ-cyclodextrin complexes were prepared by using β-Cyclodextrin(β-CD) as a taste masking agent. These complexes were evaluated for FTIR, DSC, % Entrapment Efficiency, % drug yield, and taste evaluation by E-Tongue. The optimized ratio was further evaluated by sophisticated analytical techniques such as Scanning Electron Microscopy (SEM) and X-Ray Diffraction (XRD). A central composite design (CCD) (3 ^2) was utilized to examine the effects of independent variables (amount of gum-X1 and amount of plasticizer-X2) on dependent variables (%CDRY1 and hardness Y2). The prepared gums were evaluated for drug content, organoleptic properties, in-vitro dissolution testing by fabricated disintegration apparatus, texture analysis, etc. The optimization statistics showed that on decreasing the amount of gum, in- vitro drug release increases and hardness decreases. The optimized batch MCG-2 of Promethazine MCG showed 92.34 ± 0.92% of drug release, whereas for marketed formulation (Phenergan®-25mg) drug release value was 86.19 ± 1.88%. Results provided evidence that PMZ MCGs could be a better alternative to conventional tablet formulations with improved drug release, palatability and texture.

Poly (γ) glutamic acid: a unique microbial biopolymer with diverse commercial applicability.

Microbial biopolymers have emerged as promising solutions for environmental pollution-related human health issues. Poly-γ-glutamic acid (γ-PGA), a natural anionic polymeric compound, is composed of highly viscous homo-polyamide of D and L-glutamic acid units. The extracellular water solubility of PGA biopolymer facilitates its complete biodegradation and makes it safe for humans. The unique properties have enabled its applications in healthcare, pharmaceuticals, water treatment, foods, and other domains. It is applied as a thickener, taste-masking agent, stabilizer, texture modifier, moisturizer, bitterness-reducing agent, probiotics cryoprotectant, and protein crystallization agent in food industries. γ-PGA is employed as a biological adhesive, drug carrier, and non-viral vector for safe gene delivery in tissue engineering, pharmaceuticals, and medicine. It is also used as a moisturizer to improve the quality of hair care and skincare cosmetic products. In agriculture, it serves as an ideal stabilizer, environment-friendly fertilizer synergist, plant-growth promoter, metal biosorbent in soil washing, and animal feed additive to reduce body fat and enhance egg-shell strength.

Development of an extemporaneous preparation formulation using a simple and non-solubilizing matrix for first in human clinical study

Extemporaneous preparation (EP) formulation is an attractive strategy to accelerate the formulation development of new chemical entities for first entry into human study. In this work, an EP suspension formulation for a development drug candidate GDC-6599 was successfully developed. The formulation spanned a wide concentration range from 0.1 to 2.0 mg/mL. A non-solubilizing vehicle, 0.6 % (w/v) methylcellulose solution was used to suspend GDC-6599. An aversive agent denatonium benzoate at an extremely low level (6 ppm) was applied as a taste masking agent. This enabled a simple matrix for the analysis of related substances from GDC-6599 during all stability studies. Microcrystalline cellulose at 10 mg/mL concentration was added to the EP formulation to generate a suspension appearance, leading to the success of using a single placebo for matching active formulation at all concentrations. The developed formulation demonstrated excellent homogeneity, sufficient stability and passed microbiological enumeration test. Rinsing performance test demonstrated that greater than 99.8 % amount of drug was successfully recovered by rinsing with water twice, providing guidance for clinical dosing. Biopharmaceutical assessment was conducted by both in silico simulation and in vitro tests. Greater than 90 % bioaccessibility of the EP suspension formulation was obtained via an in vitro system mimicking the human gastrointestinal absorption, consistent with the result from the in silico modeling. The developed EP formulation was successfully used to support the early single ascending dose (SAD) cohorts of GDC-6599 Phase I clinical study. The formulation matrix and assessment workflow developed in this work are generalizable as a platform for EP formulation development of new chemical entities for early phase clinical studies.

Responsive Sensory Evaluation to Develop Flexible Taste-Masked Paediatric Primaquine Tablets against Malaria for Low-Resource Settings.

Primaquine is an important antimalarial drug for malaria transmission blocking and radical cure, but it is not currently available in child-friendly formulations in appropriate doses. Adult-strength tablets are often crushed and dissolved in water to obtain the required dose, which exposes the drug's bitter taste. As part of the developing paediatric primaquine (DPP) project, this study adopted a responsive sensory pharmaceutics approach by integrating real-time formulation development and pre-clinical taste assessment to develop palatable, flavour-infused primaquine tablets. A design of experiment (DoE) approach was used to screen different taste-masking agents and excipient blends with trained, expert sensory assessors, with quinine hydrochloride as a model bitter tastant. The taste-masking efficacy of selected prototype formulation blends was validated with naïve assessors using the highest 15 mg primaquine dose. The mean bitterness intensity rating, measured on a discrete 11-point scale, was halved from 7.04 for the unflavoured control to 2.74-3.70 for the formulation blends. Sucralose had the biggest impact on bitterness suppression and improving palatability. Two different flavouring systems have been developed, and their acceptability in paediatric patients will be assessed as part of upcoming validation field clinical trials in Africa.

Formulation and evaluation of mouth dissolving film of antihypertensive agentFormulation and evaluation of mouth dissolving film of antihypertensive agent

Mouth dissolving film is the one of the most advanced oral solid dosage form because of its flexibility and comfort in use. Mouth dissolving films are oral solid dosage form that disintegrate and dissolve within a minute when placed in mouth without taking water or chewing. This dosage form allows the medication to bypass the first pass metabolism so bioavailability of medication may be improved .Mouth dissolving film has potential to improve onset of action lower the dosing and eliminate the fear of chocking. Formulation of mouth dissolving films involves both the visual and performance characteristics as plasticized hydrocolloids, API taste masking agents are being laminated by solvent casting and semisolid casting method. Solvent casting method being the most preferred method over other methods because it offers great uniformity of thickness and films prepared having fine glossy look and better physical properties. Mouth dissolving films are evaluated for its various parameters like thickness, physical property like folding endurance, disintegration and dissolution time. This review gives an idea about formulation techniques, evaluation parameters, overview on packaging and some available marketed products of mouth dissolving films.

Design and evaluate the mebendazole taste mask chewable tablets using ion exchange resin Kyron T-114

The aim of this research was to mask the bitter taste of Mebendazole using ion exchange resin and to formulate a taste masked chewable tablet. Kyron T-114 was used as a taste masking agent which was containing cross-linked polyacrylic backbone was used as taste masking agents. The drug resin complex was prepared by complexation of drug with resin using batch method. Maximum drug loading capacity of resins Kyron T-114 was calculated then Drug Resin Complexes were optimized by effect of drug resin ratio, Effect of stirring time. Effect of soaking time, effect of temperature and effect of pH on drug loading. Drug resin complex was evaluated for FTIR studies, drug release at salivary pH 6.8 and dissolution of drug resin complex at gastric pH. Taste masked chewable tablets of Mebendazole were prepared by direct compression method. Post compression evaluations used such as thickness, diameter, weight variation, hardness, disintegrating test, content uniformity test and in vitro dissolution test.

PREPARATION AND EVALUATION OF A TASTE-MASKED ARTEMETHER ORAL SUSPENSION

Objective: The antimalarial drug Artemether is bitter in taste. The purpose of this work is to construct a taste-masked Artemether resinate employing ion exchange resins. Methods: The process for drug resin complexation was adjusted in terms of drug resin ratio and medium pH. FTIR and DSC measurements were used to characterise the taste-masked complex. As an ion exchange resin, Indion 204 was used. It was combined with medication in various ratios: Indion was generated at various times and pH values and the extent of complexation was determined. Results: The result indicates that a 1:1 ratio of Indion 204 to resin resulted in the largest amount of complexation after four hours of mixing. These resinate then converted into granules and they exhibit an angle of repose, bulk density, and flow characteristic values that are acceptable. The loading of drugs was greater than 99 percent. Based on drug content, a suitable amount of drug-resinate was taken for formulation. Then Suspension was studied for general appearance, viscosity, sedimentation ratio, drug release, resuspendability. The release test showed that 92.46% of drug were release within 120 min. Conclusion: Hence we can conclude that Indion 204 has been proved to be useful as a taste-masking agent. Thus we are able to achieve our objectives of preparing a taste-masked suspension of Artemether with minimum excipients and a simple method of manufacturing.

Formulation of Levocetirizine-Loaded Core-Shell Type Nanofibrous Orally Dissolving Webs as a Potential Alternative for Immediate Release Dosage Forms.

Several applications of nanofiber-based systems are based on their corresponding functionality-related properties, which often cannot be satisfied by a fiber web with a monolithic structure because of the various physicochemical properties and amounts of embedded compounds. Therefore, one of the main directions in the development of fiber systems is creating core–shell type complex fiber structures that can provide application-specific properties to the fiber matrix. The present study aimed to formulate levocetirizine-loaded core–shell type hydrophilic polymer-based fibrous systems. The core phase contained the antihistamine levocetirizine, while the permeation enhancer (Na-taurocholate), the local pH regulator (citric acid), and the cyclodextrin used as a taste masking agent were included in the shell phase of the fibrous formulation. Scanning electron microscopy images indicated that a randomly oriented homogeneous fibrous structure was obtained, while the Raman mapping and chemometric analysis confirmed the partially formed core–shell structure. A fast release rate of the antihistamine drug from the complex structural fibrous system was obtained (within 1 min complete dissolution can be observed) due to its increased surface area to volume ratio and its more favorable wettability properties, which consequently allows for more erosion. The masking properties against the unpleasant bitter taste of API of the formulated complex nanostructure were confirmed by the results of the electronic tongue. The formulated complex nanostructure enabled fast and complete release of the API, providing a potential enhancement in the rate and extent of absorption while masking the unpleasant taste of levocetirizine, which has a high impact on the patient adherence. All in all, the results show that the developed orally dissolving fibrous web formulation can be a potential alternative to the commercially available orally disintegrating tablets.

A REVIEW ON MOUTH DISSOLVING FILM

Oral route of Mouth dissolving film is the most advanced oral solid dosage form due which it is very much in use now a day because of it’s flexibility and comfort. Mouth dissolving films are oral solid dosage form that disintegrate and dissolve within few minutes when placed in tongue without taking water. This dosage form allows the medication to bypass the first pass metabolism, so that the bioavailability of medication can be improved .Mouth dissolving film has potential to improve onset of action lower the dosing and eliminate the fear of chocking. Formulation of mouth dissolving films involves both the visual and performance characteristics as plasticized hydrocolloids, API’s taste masking agents are being laminated by solvent casting and semisolid casting method. Solvent casting method being the most preferred method over other methods because it offers great uniformity of thickness and films prepared having fine glossy look and gives them the better physical properties. Mouth dissolving films are evaluated for its various parameters like dissolution time, disintegration thickness, physical property like folding endurance. This review gives an idea about formulation techniques, evaluation parameters, overview on packaging and some available marketed products of mouth dissolving films.

Development of a Hospital Compounded, Taste-Masked, Temozolomide Oral Suspension and 5-Year Real-Life Experience in Treating Paediatric Patients.

The development of oral pediatric forms by pharmaceutical companies is still insufficient. In fact, many drugs used in paediatric oncology, such as temozolomide, are not labeled and adapted for paediatric use. Temozolomide (TMZ) is an alkylating agent used as the standard of care for many adult and pediatric brain tumours, such as neuroblastoma, glioblastoma and medulloblastoma. The present study was carried out to propose a suitable and palatable formulation of the oral liquid preparation of TMZ. The suspension is composed of TMZ suspended in SyrSpend SF pH 4, as well as TMZ crystallization stabilizing agents and sweetening agents. To reach this formulation, several taste-masking agents were evaluated. Here, we describe the method of preparation of the formation as well as the monocentric population treated with the formulation over a 5–year period. A 20 mg/mL TMZ suspension was developed. TMZ suspension is stable for 6 weeks, stored between 2 and 8 degrees, protected from light, and compatible with nasogastric tubes. Thirty-eight patients participated in the palatability study and choose cola flavour, and 104 patients were treated in Gustave Roussy with the developed suspension; no unexpected event was reported. To conclude, we propose here a new TMZ liquid formulation which is stable for at least 6 weeks and well-tolerated with extensive feedback.

Formulation and evaluation of taste masked oral disintegrating tablets of lornoxicam

Orally disintegrating tablets (ODT) disintegrate quickly with saliva when administered into the oral cavity and taken without water or chewed. ODT are easy to take for children and the elderly, who may experience difficultly in taking ordinary oral preparations such as tablets, capsules, and powders. The ODT threes substantial benefits for the patient (or elder) who cannot swallow (Dysphagia), or who is not permitted water intake due to disease. The reason of the current research was to prepare taste masking oral disintegrating tablets of poorly soluble lornoxicam (LXM) by direct compression technique using Kyron T-114 (cation exchange resin) as a taste masking agent. With in various ratios the Drug-resin of 1:4 was established to present best taste masking. The superdisintegrants used in formulation are croscarmellose sodium and cross povidone. Among these croscarmellose sodium demonstrated superior drug release. The tablets were evaluated for friability, weight variation, wetting time, hardness, disintegration time and uniformity of content. Optimized formulations were evaluated for in vitro dissolution test. Amongst all the formulations F-6 was found to be most successful tablets prepared by this technique had disintegration time of 30sec and % CDR 94.78 within 30min. Hence, this advance can be utilized for taste masking of bitter pharmaceutical ingredients leading to superior patient compliance.
 Keywords: Oral disintegration tablets, Lornoxicam, Kyron T-114, Superdisintegrants, Direct Compression.

FORMULATION, IN VITRO, AND IN VIVO EVALUATION OF TASTE-MASKED ORAL DISINTEGRATING TABLETS OF FEXOFENADINE HYDROCHLORIDE USING SEMISYNTHETIC AND NATURAL SUPERDISINTEGRANTS

Objective: The aim of the present research work was to prepare and evaluate taste-masked oral disintegrating tablets (ODT) of Fexofenadine hydrochloride. Methods: In the present work, Eudragit EPO, a taste masking agent and Karaya gum (GK) (natural), Sodium starch glycolate, and Croscarmellose sodium (CCS) (semi-synthetic) super disintegrants in three ratios (3, 6,9%) were used. Taste masked granules were prepared by different ratios of the drug: Eudragit EPO (1:1, 1:1.5, 1:2) by wet granulation method. The optimized taste-masked granules (1:2) were selected by sensory evaluation test to prepare 9 Fexofenadine ODT (FH1-FH9) formulations. These were evaluated for different parameters. Then desirability function (DF) was calculated for all formulations using disintegration time (DT), time taken for the tablet to release 90% of the drug (t 90%), and % drug dissolved in 10 min (Q10) as significant parameters. Results: The best formulation (FH6) showed the highest DF value due to less DT and 100% in vitro drug release within 15 min. Thus, FH6 formulation containing 9% CCS was selected as the best among the prepared formulations to which in vivo studies were performed on rabbits to find maximum plasma concentration (Cmax), time taken to reach maximum concentration (tmax), area under the curve (AUC), rate of elimination (Kel), absorption rate (Ka) and half-life(t1/2) and compared with Fexofenadine (Allegra) marketed tablets. Total bioavailability was increased for the test formulation compared to the reference formulation. Conclusion: Fexofenadine was successfully prepared as ODT with increased AUC and decreased tmax to which stability studies were conducted which were found to be stable.

Evaluation of Antacid Potential of Ayurvedic Poly-Herbal Formulation for Functional Dyspepsia

Aim: Ayurveda describes herbal or polyherbal or herbo-mineral medicines such as Avipattikar churna for treatment of Amlapitta, ajirna for centuries. Ayurvedic medicines are associated with limitations namely, palatability, stability and accuracy of dose. Ayurvedic medicines lack in adequate safety and efficacy evidence data. The aim of the study was to develop a stable and palatable Avipattikar suspension using recent formulation and analytical techniques. The study was also aimed at determination of acid neutralizing capacity of Avipattikar suspension and predicting its efficacy for treatment of Functional Dyspepsia and Gastroesophageal Reflux Disorder. Methods: Flocculated Avipattikar suspension was prepared using sodium carboxymethylcellulose (CMC) as the suspending agent, sodium citrate as the flocculating agent, mannitol as a taste masking agent. Sodium carboxymethylcellulose, sodium citrate, Tween 80®, glycerin and mannitol were not used in Deflocculated Avipattikar suspension. The sedimentation volume, degree of flocculation, redispersibility and pH of the suspension was evaluated. The acid neutralization capacity of Avipattikar suspension was determined by Unite States Pharmacopoeia method.
 Results: The present study successfully demonstrated formulation of stable Avipattikar suspension from Avipattikar churna. The suspendability of sediment was retained for 15 days in presence of CMC. The results indicated that the acid neutralizing capacity of Avipattikar suspension (2.80 mMol of H+/ gm) was similar to that of the marketed antacid suspension (2.756 mMol of H+/ gm). The unpleasant taste of herbal drugs was masked satisfactorily.
 Conclusion: Avipattikar suspension may be a cheaper, safer and effective alternative for current antacids for the treatment of functional dyspepsia.

DEVELOPMENT AND EVALUATION OF MEDICATED CHEWING GUM OF RALOXIFENE HYDROCHLORIDE

In this study we formulate Raloxifene hydrochloride, edicated chewing gum to overcome first pass metabolism of it so bioavability increase of drug. We take polyvinyl acetate as chewing gum base. Aspartame, mannitol and sucrose as sweetener. Glycerin as a plasticizer. Beta-cyclodextrine as solubility enhancer and taste masking agent. First we evaluate the API by its melting point after we derived its calibration curve. After this we select proper ratio of Beta-cyclodextrine and API. After we study drug and excipients compatibility by using FTIR. XRD study perform for API and formulation. After we formulate our formulation and perform post-evaluation study like hardness, weight variation, % drug content and % drug release. From all formulation F5 formulation shows best % drug release and % drug content. After we perform stability study for our formulation and after study no major change show in formulation. And in last we perform buccal permeability study. On basis of all study results we can say that our formulation is successfully formed.
 Keywords: Raloxifene hydrochloride, Medicated chewing gum, Buccal permeation, Osteoporosis.

Formulation of sublingual promethazine hydrochloride tablets for rapid relief of motion sickness

The delivery of antihistaminic agents via the oral route is problematic, especially for elderly patients. This study aimed to develop a sublingual formulation of promethazine hydrochloride by direct compression, and to mask its intensely bitter taste. Promethazine hydrochloride (PMZ) sublingual tablets prepared by direct compression were optimized using Box-Behnken full factorial design. The effect of a taste-masking agent (Eudragit E 100, X1), superdisintegrant (crospovidone; CPV, X2) and lubricant (sodium stearyl fumarate; SSF, X3) on sublingual tablets’ attributes (responses, Y) was optimized. The prepared sublingual tablets were characterized for hardness (Y1), disintegration time (Y2), initial dissolution rate (IDR; Y3) and dissolution efficiency after 30 min (Dissolution Efficiency (DE); Y4). The obtained results showed a significant positive effect of the three independent factors on tablet hardness (P < 0.05), and the interactive effect of Eudragit E 100 and CPV on tablet hardness was significant. Disintegration time was mainly affected by Eudragit E 100 and CPV concentrations. Moreover, IDR was employed to assess the taste masking effect, lower values were obtained at higher Eudragit E 100 concentration despite it was statistically insignificant (p > 0.05). Optimized formulation that was suggested by the software was composed of: Eudragit E 100 (X1) = 2.5% w/w, CPV (X2) = 4.13% w/w, and SSF (X3) = 1.0% w/w. The observed values of the optimized formula were found to be close to the predicted optimized values. The Differential Scanning Calorimetric (DSC) studies indicated no interaction between PMZ and tablet excipients.

Extemporaneous printing of diclofenac orodispersible films for pediatrics

Objective The possible application of a hot-melt ram extrusion printing to the preparation of diclofenac orodispersible films (ODF) made of maltodextrin was studied focusing the attention on the effects of taste-masking agents (i.e. namely mint, licorice-mint, and sucralose) and an opacifier (titanium dioxide [TiO2]). Significance This is a proof-of-concept of the feasibility to print ODF loaded with a thermosensitive drug substance by hot-melt technologies. Methods Diclofenac sodium (DNa) ODF made of maltodextrin (dextrose equivalent (DE) = 6 ) plasticized with glycerol were prepared by hot-melt extrusion printing. ODF were characterized for disintegration time, drug content, and solid state, in vitro dissolution in deionized water and simulated salivary fluid at pH 5.7, tensile, and adhesive properties. Moreover, the stability of ODF was assessed in accelerated conditions over six months. Results After the preparation, no variation in drug solid state was evident and the formation of impurity A of DNa was detected, even if it remained below the Pharmacopoeia (Ph. Eur.) limits (< 0.2%). Only the addition of DNa significantly improved the ODF tensile properties: the tensile strength increased from 0.17 ± 0.03 MPa (placebo ODF) to 2.21 ± 0.54 MPa (p ≤ 0.03). All ODF disintegrated in about 1 min, and the t80% was lower than 3 min. TiO2 reduced the static and dynamic peel forces (p ≤ 0.006) favoring the ODF detachment from the primary packaging material. During the accelerated stability study, ODF were easy to handle without fracture; the drug content, impurity A, and dissolution profiles remained superimposable. Conclusion Hot-melt printing can be suitable to prepare palatable ODF loaded with bitter thermosensitive drugs.

Natural polymers in pharmaceutical drug delivery: A review

In pharmaceutical formulation two main ingredients are required which is API and excipient. And excipient contains many components which plays vital role in manufacturing of dosage form as well as improve pharmaceutical parameters of the dosage form. Polymers used in any dosage form as excipient. Polymers have influencing capacity towards drug release and should be compatible, stable, non-toxic and economic etc. Generally, polymers are classified into three categories i.e natural, semi-synthetic and synthetic polymers. Nowadays, many pharmaceutical companies inclined towards using natural polymers due to many problems created with drug release and side effects. Polymers plays various application in formulation as excipient like to provide uniform drug delivery, rate controlling agent, taste masking agent, protective and stabilizing agents, etc. So that this review discuss about various natural polymers, there advantages over synthetic polymers and role of polymers in designing drug delivery system.

Fixed Dose Oral Dispersible Tablet of Bitter Drug Using Okra Mucilage: Formulation and Evaluation

Background: The solid oral dosage forms containing bitter drugs need improved palatability for administration. Formulation scientists have given attention to the improvement of taste masking technologies and utilised various strategies.&#x0D; Objective: The present work aimed to mask the bitter taste of Promethazine Hydrochloride by formulating Oral Dispersible Tablets using Okra mucilage as a taste-masking agent. &#x0D; Methods: The Okra mucilage was extracted from Okra by the aqueous extraction process. An emulsion solvent diffusion technique was used for masking the bitter taste of Promethazine Hydrochloride by using Okra mucilage. The Oral Dispersible Tablet was prepared by the wet granulation method. The mucilage and the formulation were characterized and evaluated by standard methods and protocols.&#x0D; Results: Taste masking of the bitter drug was successfully achieved by Okra mucilage. The DSC and FTIR study revealed that the drug molecule was compatible with okra mucilage and drug entrapment efficacy was found to be 94.76%. The palatability test asserted that masking of the bitter taste of the drug. The In vitro drug release study showed that the F7 tablet batch has a better drug release rate and followed non- fickian mechanism of drug release.&#x0D; Conclusion: Thus, taste masking with Okra mucilage was successful and this opens opportunities for application of common edible substances in formulation development.&#x0D; Keywords: Fast disintegrating tablet; Natural polymer; Mouth dissolving tablet; Promethazine Hydrochloride; Taste masking