Chewable Tablet Formulation Research Articles

Formulation and Evaluation of Ceftazidime Chewable Tablets

Formulation and Evaluation of Ceftazidime Chewable Tablets

Using Chia Powder as a Binder to Obtain Chewable Tablets Containing Quinoa for Dietary Fiber Supplementation

The consumption of fiber in the human diet is a global recommendation to ensure a healthy diet. Quinoa (Chenopodium quinoa Willd.), a gluten-free grain, and chia (Salvia hispanica), a seed, contain a high fiber content, and both have the potential to be used in the development of nutraceutical and pharmaceutical formulations. An interesting characteristic of chia is its ability to form viscous mucilage when in contact with water, making it a potential binder in solid formulations. However, there are no studies on chia as a binder, and therefore, the objective of the present study was to evaluate the feasibility of using chia as a binder to produce quinoa granules and, subsequently, develop chewable tablet formulations. The quinoa and chia were in a powder form and then transformed into a wet mass with the help of mixer torque rheometer (MTR) equipment. In the wet granulation form, the following parameters were tested: multiple additions, 15 g of material, and 25 timepoints for the addition of 1 mL of water. An experimental design was carried out to evaluate the impact of the variables on the MTR results for subsequent granulation. The granulation point was possible for T1–T9, and most formulations gave satisfactory results, such as an acceptable resistance of the granules. In the end, a formulation was selected for the development of chewable tablets containing quinoa and chia fibers.

Formulation and evaluation of Chewable tablets Containing Dexibuprofen as an Antipyretic Drug

Antipyretic medications are frequently required for fever, a natural physiological reaction to infection or inflammation, to reduce symptoms and enhance patient comfort. The active enantiomer of ibuprofen, dexibuprofen, offers a more appealing substitute because of its improved pharmacokinetic characteristics, which include a longer half-life and less gastrointestinal side effects. To overcome the drawbacks of traditional dose forms and enhance patient compliance, particularly in the case of juvenile and geriatric populations, this research study describes the development and assessment of a unique chewable tablet containing dexibuprofen as an antipyretic medication. To maximize medication distribution and improve palatability, dexibuprofen was carefully blended with excipients and flavoring ingredients during the formulation process. The prepared chewable tablets were thoroughly examined for their physical attributes, homogeneity of drug content, disintegration time, dissolution profile, and palatability. According to the results, the chewable tablets met or exceeded pharmacopeial requirements for positive qualities such as consistent drug content, quick disintegration, complete dissolve, and acceptable palatability. The study's conclusions imply that the chewable tablet that was created offers a viable way to manage fevers, addressing issues with conventional dose forms while offering quick and efficient relief. Furthermore, the chewable formulation's appeal and convenience may help to boost treatment results and patient adherence, which would increase overall therapeutic efficacy in fever management circumstances.

Soluble thiabendazolium salts with anthelminthic properties

Thiabendazole is an anthelmintic drug used to treat strongyloidiasis (threadworm), cutaneous and visceral larva migrans, trichinosis, and other parasites. The active pharmaceutical ingredient is typically administered orally as tablets that should be chewed before swallowing. Current formulations combine the active ingredient with excipients, including sodium saccharinate as a sweetener. Thiabendazole’s low aqueous solubility hinders fast dissolution and absorption through the mucous membranes. We sought to reformulate this medicine to improve both solubility and palatability. We utilized the possibility of protonation of the azole nitrogen atom and selected four different hydrogen donors: saccharin, fumaric, maleic, and oxalic acids. Solvothermal synthesis resulted in salts with each co-former, whereas neat and liquid-assisted grinding enabled the synthesis of additional formulations. Product formation was observed by powder X-ray diffraction. To better understand the structural basis of the proton transfer, we solved the crystal structures of the salts with saccharin, maleic acid, and oxalic acid using single-crystal X-ray diffraction. The structure of the salt with fumaric acid was solved by powder X-ray diffraction. We further characterized the salts with vibrational spectroscopic and thermoanalytical methods. We report a broad tunability of the aqueous solubility of thiabendazole by salt formation. Reformulation with maleic acid provided a 60-fold increase in solubility, while saccharin and oxalic acid gave a modest improvement. Fumaric acid resulted in a solid with only slightly higher solubility. Furthermore, saccharin is a sweetener, while the acids taste sour. Therefore, the salts formed also result in an intrinsic improvement of palatability. These results can inform new strategies for oral and chewable tablet formulations for treating helminthic infections.

A comparative absorption study of sucrosomial® orodispersible vitamin D3 supplementation vs. a reference chewable tablet and soft gel capsule vitamin D3 in improving circulatory 25(OH)D levels in healthy adults with vitamin D deficiency-Results from a prospective randomized clinical trial.

Vitamin D (Vit D) deficiency (VDD), associated with diverse health conditions, is commonly treated with Vit D3 supplements. However, the gastrointestinal (GI) absorption of Vit D3 in different formulations has not been well studied. We aimed to compare the absorption of an innovative phospholipids-sucrester matrix biodelivery vehicle-based (sucrosomial®) orodispersible Vit D3 preparation against a reference chewable tablet and soft gel capsule (SGC) Vit D3 formulations in Vit D-deficient healthy adults. In study 1, 25 subjects were randomized to receive a weekly single dose of 200,000 IU of sucrosomial® Vit D3 (n = 12) or chewable tablet Vit D3 (n = 13) for 3 weeks. In study 2, 20 subjects were randomized to receive a single dose of 200,000 IU every other week of sucrosomial® Vit D3 (n = 10) or SGC Vit D3 (n = 10) for 6 weeks. Circulatory 25-hydroxyvitamin D3 [25(OH)D] levels were reassessed after 2, 3, and 6 weeks in study 1 and after 4 and 6 weeks in study 2. In study 1, after 2 weeks, circulatory 25(OH)D levels increased significantly in both Vit D3 treatment groups (p < 0.0001) but improved markedly in the sucrosomial® Vit D3 group, with no further considerable change after 3 and 6 weeks in both groups. Overall, at all three follow-ups, sucrosomial® Vit D3 treatment achieved significantly higher and sustained 25(OH)D levels (p < 0.001). In study 2, after 4 weeks, both Vit D3 treatment groups showed significant improvement in circulatory 25(OH)D levels (p < 0.0001) but substantially higher in the sucrosomial® group with statistically significant differences between the two treatment groups (p = 0.02). At the 6-week follow-up, only subjects in the sucrosomial® Vit D3 group showed a further increase in circulatory 25(OH)D levels (p = 0.049), but no further significant changes in the levels of the SGC Vit D3 group (p = 0.062), showing a statistically significant difference between the two treatment groups (p = 0.002). The Vit D3 treatment was well tolerated by all participants, and no treatment-emergent effects or serious adverse events were reported. Our results suggest that the sucrosomial® Vit D3 preparation absorbs efficiently in the GI system, achieving adequately higher and sustained circulatory Vit D levels in VDD, and thus can effectively contribute to the body protection against VDD-associated health conditions. clinicaltrials.gov, identifier: NCT05706259.

FORMULASI TABLET KUYAH DARI MINYAK ATSIRI JERUK KALAMANSI (Citrofortunella microcarpa) DENGAN VARIASI PEMANIS SORBITOL

In the essential oil of calamansi orange peel, the main component is limonene, which is known to have antimicrobial and antiseptic activity. The chewable tablet dosage form is considered suitable to be combined with calamansi orange essential oil which has been proven to have antibacterial properties, so it is necessary to add variations of sorbitol sweetener. The general objective of this research is to obtain chewable tablets that have good physical properties and taste that are accepted by the market. This study examined (1) the physical evaluation test of all chewable tablet formulations meeting the physical evaluation requirements (weight uniformity test, size uniformity test, and taste response test) (2) taste response test was carried out on variations in the use of sorbitol. The chewable tablets were formulated in 3 groups, FI (Sorbitol 50%), FII (sorbitol : 60%) and FIII (Sorbitol : 70%), and the formulation of the chewable tablets used the direct compression method. The test results for the physical properties of the tablets showed that all tablets met the requirements. The effect on the use of sorbitol in the formulation increased the hardness, friability, and sweetness of the tablets, but had no effect on the uniformity of the weight and uniformity of the size of the tablets. The formulation of the chewable tablet which was very good was seen from the results of the physical properties test and the taste response of the tablet and the best formulation was Formula III

Formulation and Evaluation of Chewable Tablets from Natural Extracts: A Systematic Literature Review

Formulation of chewable tablets from extracts of natural ingredients requires special attention in designing preparations that maintain the quality and stability of the active ingredients. The extract must have the desired pharmacological effect and be proven safe to use. This study aimed to carry out a systematic review in order to explore formulations of chewable tablets made from natural ingredients. The literature search process was carried out on various databases (PubMed, Web of Sciences, EMBASE, Cochrane Libraries, and Google Scholar) regarding the formulation and evaluation of chewable tablets from natural extracts. This study follows the preferred reporting items for systematic reviews and meta-analysis (PRISMA) recommendations. Formulation of chewable tablets from extracts of natural ingredients is an interesting approach in the development of pharmaceutical preparations. Through a selection of appropriate extracts, careful evaluation of stability, and attention to taste and aroma, these chewable tablets can provide significant benefits to patients. However, it is important to carry out careful research and testing to ensure the safety, effectiveness, and quality of these products before they are used in clinical practice.

Design and Development of Oxyclozanide Chewable Tablet Formulation Employing Quality by Design Approach

Abstract: Background: The focus of this research was to identify undiscovered knowledge associated with the production of oxyclozanide tablets utilizing Quality by Design (QbD) in order to develop an ideal formulation that would guarantee constant product quality. The modern approach to formulation design and optimization essentially entails QbD which is a systemic method of pharmaceutical development and comprises of the design and development of formulations as well as manufacturing processes to meet the target product quality. Materials and Methods: Pre-formulation studies on excipient flow properties, compactibility and tabletability profiles, identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) were carried out. An experimental design was adopted to investigate the effect of formulation and process variables (compression force, super-disintegrant type and concentration) on the CQAs using Modde Pro 12.1. The obtained results were used to generate a Design Space (DS) based on the study data. Results: Preformulation studies carried out on the core excipients used, gave an understanding to their tabletability and compactibility. Process parameters such a compaction force and formulation variables such as super-disintegrant concentration were studied within the framework of Quality by Design (QbD) and the new optimized formulation derived was tested and confirmed to be within the design space generated. Conclusion: At the end of the study, the aim was achieved; which was to implement pre-formulation studies and QbD to design a formulation containing Oxyclozanide (API) with a combination of excipients. Keywords: Quality by Design (QbD), Oxyclozanide, Chewable tablet, Compactibility, Tabletability.

Chewable tablet with herbal extracts and propolis arrests Wuhan and Omicron variants of SARS-CoV-2 virus.

Prevention of COVID-19 is of paramount importance for public health. Some natural extracts might have the potential to suppress COVID-19 infection. Therefore, this study aimed to design a standardised, efficient, and safe chewable tablet formulation (with propolis and three herbal extracts) for possible prevention against two variants (Wuhan B.1.36 and Omicron BA.1.1) of SARS-CoV-2 virus and other viral infections. Green tea, bilberry, dried pomegranate peel, and propolis extracts were selected for this purpose. Cytotoxicity and antiviral activity of each component, as well as the developed chewable tablet, were examined against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus using Vero E6 cells with the xCELLigence real-time cell analyser-multiple plates system. Anti-inflammatory and analgesic activities, as well as mutagenicity and anti-mutagenicity of the chewable tablet were also analysed. Compared to the control, it was observed that the chewable tablet at concentrations of 110 and 55µg/mL had antiviral activity rates of 101% and 81%, respectively, for the Wuhan variant and 112% and 35%, respectively, for the Omicron variant. The combination of herbal extracts with propolis extract were synergically more effective (∼7-fold higher) than that of individual extract. The present work suggests that a combination of herbal extracts with propolis at suitable concentrations can effectively be used as a food supplement for the prevention of both variants of the SARS-CoV-2 virus in the oral cavity (the first entry point of the SARS-CoV-2 virus).

Formulation and Evaluation of Poly Herbal Chewable Tablets from Ayurvedic Ingredients having Cough Relieving Activity

Formulation and Evaluation of Poly Herbal Chewable Tablets from Ayurvedic Ingredients having Cough Relieving Activity

Formulation of novel niosomal repaglinide chewable tablets using coprocessed excipients: in vitro characterization, optimization and enhanced hypoglycemic activity in rats

Repaglinide (RPG), a monotherapy insulin secretagogue used to treat diabetes mellitus-type II yet, it suffers from poor water solubility and variable bioavailability (∼ 50%) due to hepatic first pass metabolism. In this study, 2FI I-Optimal statistical design was employed to encapsulate RPG into niosomal formulations using cholesterol,span 60 and peceolTM. The optimized niosomal formulation (ONF) showed particle size 306.60 ± 84.00 nm, zeta potential −38.60 ± 1.20 mV, polydispersity index 0.48 ± 0.05 and entrapment efficiency 92.00 ± 2.60%. ONF showed > 65% RPG release that lasted for 3.5 h, and significantly higher sustained release compared to Novonorm® tablets after 6 h (p < 0.0001). TEM for ONF showed spherical vesicles with dark core and light-colored lipid bilayer membrane. RPG peaks disappeared in FTIR confirming successful RPG entrapment. To eliminate dysphagia associating conventional oral tablets, chewable tablets loaded with ONF were prepared using coprocessed excipients; Pharmaburst® 500, F-melt® and Prosolv® ODT. Tablets showed friability <1%, hardness 3.9 ± 0.423-4.7 ± 0.410 Kg, thickness 4.1 ± 0.045-4.4 ± 0.017 mm and acceptable weight.All tablets showed robust RPG release at 30 min compared to Novonorm® tablets. At 6h, chewable tablets containing only Pharmaburst® 500 and F-melt® showed sustained and significantly increased RPG release compared to Novonorm® tablets (p < 0.05). Pharmaburst® 500 and F-melt® tablets showed rapid in vivo hypoglycemic effect with 5 and 3.5 fold significant reduction in blood glucose compared to Novonorm® tablets (p < 0.05) at 30 min. Also, at 6h the same tablets showed 1.5 and 1.3 fold significant extended reduction in blood glucose compared to the same market product (p < 0.05). It could be concluded that chewable tablets loaded with RPG ONF represent promising novel oral drug delivery systems for diabetic patients suffering from dysphagia.

Formulation and In -Vitro Evaluation of Metoclopramide Hydrochloride Chewable Tablets

The objective of the present research work was to develop a formulation of Metoclopramide HCl chewable tablets with efficacy and better palatability. Metoclopramide HCl belongs to the class of Anti-emetic which is used to treat nausea and vomiting. Metoclopramide HCl chewable tablets were prepared by the direct compression method. Chewable tablets were prepared and evaluated. The pre-formulation studies of FT-IR revealed that there was no significant interaction observed between the drug and excipients. Formulated chewable tablets were characterized for appearance, weight variation, hardness, friability, moisture content determination, drug content, in-vitro drug release studies and drug release kinetic studies. Formulation F3 released 98.167% drug at the end of 4th min better than other formulations and obeyed Korsmeyer peppa’s drug release kinetics. Formulation F3 could be considered as best formulation based on drug release profile, physical texture and other properties. Metoclopramide HCl chewable tablets could be serve as promising drug delivery dosage form for geriatric and pediatric patients with improved palatability.

Speed of onset of a new chewable formulation of oclacitinib maleate (Apoquel®) in a canine model of IL-31-induced pruritus.

Oclacitinib maleate (Apoquel®, Zoetis Inc.) is commonly used around the world for the control/treatment of pruritus associated with allergic dermatitis and the control/treatment of atopic dermatitis in dogs at least 12 months of age. A new flavored chewable formulation of oclacitinib has been developed where more than 90% of doses offered to dogs were freely accepted when tested in clinical trials. The objective of this study was to determine whether the new chewable formulation of oclacitinib has a similar onset of anti-pruritic activity as the original oclacitinib film-coated tablets (FCT). Twenty-one laboratory beagle dogs were randomized to treatment and received placebo, 0.4-0.6mg/kg oclacitinib FCT or 0.4-0.6mg/kg flavored chewable oclacitinib tablet (n=7/group). Efficacy was measured by assessing reduction in pruritus 1-3h post-administration of treatments. Pruritus was induced by injecting canine IL-31, intravenously (2.5μg/kg), approximately 15 min prior to the pruritus observation window. Results from this study demonstrated both oclacitinib FCT and the flavored chewable oclacitinib tablet significantly reduced IL-31-induced pruritus within 1-3h post-dosing compared to placebo (p=.0069 and .0113, respectively), suggesting the new formulation of oclacitinib chewable tablets works as quickly to reduce pruritus in dogs as the oclacitinib FCT.

Fluralaner 5.46% (w/w) flavored chewable tablet (Bravecto\xae 1-Month) is effective for treatment of canine generalized demodicosis

BackgroundOrally administered fluralaner (13.64% w/w) is effective for treating canine generalized demodicosis. A study was initiated to assess the efficacy of a novel 5.46% w/w fluralaner chewable tablet formulation for monthly administration in the treatment of this disease.MethodsClient-owned dogs diagnosed with generalized demodicosis were acclimatized to laboratory conditions and randomized to receive either orally administered fluralaner (Bravecto® 1-Month) (10.0 to 14.4 mg/kg body weight) (n = 8) or topical imidacloprid-moxidectin (Advocate® for dogs, Elanco) applied per label on days 0, 28, and 56 (n = 8), or more frequently for ongoing severe demodicosis. On days −2, 28, 56, and 84, deep skin scrapings were taken from five sites on each dog for mite identification and counting, and semiquantitative clinical assessments of generalized demodicosis were recorded. Primary efficacy was based upon arithmetic mean mite count reductions relative to pre-treatment.ResultsBy day 28, mean pre-treatment mite counts, > 600 in both groups, were significantly reduced by 99.7% and 89.5% (both P < 0.001) in the fluralaner and imidacloprid-moxidectin groups, respectively. Parasitological cure (100% reduction in mite counts on days 56 and 84) was achieved in all fluralaner-treated dogs (100%) and in two imidacloprid-moxidectin-treated dogs (25%). In the imidacloprid-moxidectin group, the reduction in mean mite counts was 89.5% (day 28), 94.4% (day 56), and 97.5% (day 84). All study dogs were free of crusts on days 56 and 84. Scales resolved by day 84 in all fluralaner-treated dogs and in three imidacloprid-moxidectin-treated dogs. All fluralaner-treated dogs and five imidacloprid-moxidectin-treated dogs had > 90% hair regrowth on day 84.ConclusionThree consecutive monthly orally administered treatments with fluralaner (5.46% w/w) flavored chewable tablets (minimum dose rate 10 mg/kg body weight) eliminated Demodex canis mites from dogs diagnosed with generalized demodicosis.Graphical

An open-label phase 2 trial to assess the efficacy, safety and pharmacokinetics of lanthanum carbonate in hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis

BackgroundThis study assessed the efficacy, tolerability and pharmacokinetics (PK) of lanthanum carbonate (LC) in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) undergoing dialysis.MethodsThis was a three-part, multicenter, open-label study of LC (oral powder formulation) in patients 10 to < 18 years old with CKD undergoing dialysis. In part 1, the single-dose PK of LC (500 mg, ≤12 years old; 1000 mg, > 12 years old) were summarized. In part 2, patients received calcium carbonate (CC [chewable tablet formulation]) (1500–6500 mg [total daily dose]) followed by LC (powder formulation) (1500–3000 mg [total daily dose]), or LC only (1500–3000 mg [total daily dose]), each for 8 weeks. During part 3, patients received LC (1500–3000 mg [total daily dose]) for up to 6 months. The primary efficacy endpoint was the proportion of LC-treated patients achieving serum phosphorus control after 8 weeks during parts 2 and/or 3, defined as: ≤1.94 mmol/L, < 12 years old; ≤1.78 mmol/L, ≥12 years old. Secondary efficacy endpoints included: the proportion of patients who achieved serum phosphorus control after 8 weeks of treatment with CC followed by 8 weeks of treatment with LC (with a washout period between treatments). The safety of LC and CC was also evaluated.ResultsIn part 1, 20 patients received a single dose of LC. In part 2, 53 and 51 patients were treated with CC and LC for 8 weeks, respectively. During part 3, 42 patients received LC for up to 6 months. Most patients were white and male. For the primary efficacy endpoint, 50% (17/34) of patients who received LC for 8 weeks during parts 2 and/or 3 achieved serum phosphorus control. After 8 weeks of treatment with CC, 58.8% of patients achieved serum phosphorus control; after a subsequent washout period and 8 weeks of treatment with LC, 70.6% of patients achieved serum phosphorus control. Tmax and t1/2 occurred within 3–8 h and ~ 19 h, respectively; however, variability was observed. LC and CC were generally well tolerated.ConclusionsThese data support the use of LC to manage hyperphosphatemia in pediatric patients with CKD undergoing dialysis.Trial registrationClinicalTrials.gov identifier: NCT01696279; EudraCT identifier: 2012–000171-17.Date of registration: 01/10/2012.

Formulation and Evaluation of Chewable Tablets of Anti-Asthmatic Drug

Montelukastsodium is a selective, orally acting leukotriene receptor antagonist that is used for the treatment of asthma and seasonal allergic rhinitis. In addition, patients with asthma need fast and immediate action of drug and avoidance of water is also desirable. Further, chewable tablets are beneficial for patients having difficulty in swallowing. The objective of the present study was to develop chewable tablets containing different compositions of ingredients by using direct compression method. Microcrystalline cellulose, mannitol, magnesium stearate, cross povidone and aspartame were used in the formulation in different concentrations. The prepared tablets were evaluated for various parameters like weight variation, thickness, friability, drug content, and in-vitro drug release. The in-vitro release study of formulation F7 was found to show 98% drug release in 30 minutes and stability studies showed no significant changes.

Development of raft-forming liquid and chewable tablet formulations incorporating quercetin solid dispersions for treatment of gastric ulcers

Gastroretentive raft-forming formulations were developed in liquid and chewable tablet dosage forms to achieve prolonged delivery of quercetin in the stomach. The formulations contained a solid dispersion of quercetin and polyvinylpyrrolidone (PVP K 30) at a 1:10 w/w ratio to improve the solubility of the flavonoid. The formulations also contained sodium alginate as a gel forming agent, calcium carbonate as a calcium source and carbon dioxide producer and hydroxypropyl methylcellulose K100M as a drug release retarding polymer. The chewable tablets incorporated mannitol as a diluent. Both liquid and chewable tablet formulations exhibited rapid floating behaviour (lag time < 1 min) and long floating duration (>24 h) in 0.1 N HCl. The optimized liquid formulation showed superior characteristics based on high raft strength (10.4 g) and sustained release of quercetin (93 % over 8 h) whereas the optimized chewable tablet formulation exhibited lower raft strength (7.2 g) and lower drug release (79 % in 8 h). The optimized liquid and chewable tablet formulations were found to induce anti-inflammatory activity in cell culture using RAW 264.7 cells macrophages and enhance the migration of human gastric adenocarcinoma (AGS) epithelial cells in vitro, indicating wound healing potential for treatment of gastric ulcers.

Development and Evaluation of Carminative Herbal Chewable Tablets Based on Turmeric, Fennel Seed, and Mango Ginger

The present study aimed at the formulation of carminative herbal chewable tablets using herbal constituents. Curcuma longa (turmeric), Foeniculum vulgare (fennel), and Curcuma amada (mango ginger) are the most celebrated herbs in Indian system of traditional medicine. In the present research work, oral chewable tablets were prepared by direct compression and wet granulation method incorporating these three herbs. In both the methods, the powder of turmeric, fennel seed, and ginger mango was prepared initially and it was mixed with additives and preservatives. Physicochemical analysis of the individual drugs, pre-formulation studies, and post-formulation standardization was done to evaluate the quality and purity of the conformation. In the pre-formulation study, it was observed that all the parameters checked for the ingredients were within standard range. Thus, the ingredients were processed for preparing tablets following IP. During the evaluation of tablets, it was found that all the prepared batches of tablets were within the standard range of chewable tablet parameters. Thus, considering these values and following the IP, we found that the chewable tablet that was prepared without altering its therapeutic property was satisfactory with general characteristics of tablet, namely, hardness, disintegration time, friability, and weight variation. The formulation was tested for common people with respect to taste; odor and time required for complete chewing and showed that it can be accepted for the present trends of newer drug delivery dosage forms. The present study provides an approach to come up with a modern outlook to traditional folklore formulations without altering its therapeutic property which is highly essential in industrial applications and to meet consumer preferences and demands. Therefore, it is concluded that the developed chewable tablets may be better alternative to the conventional uses of the herbs.

Formulation of Chewable Tablets Containing Carbamazepine-β-cyclodextrin Inclusion Complex and F-Melt Disintegration Excipient. The Mathematical Modeling of the Release Kinetics of Carbamazepine.

Due to its low solubility, carbamazepine (CBZ) exhibits slow and incomplete release in the gastrointestinal tract and, hence, variable pharmacokinetics and pharmacodynamic effect. Lots of methods have been devised to improve its solubility, the large number of proposed solutions being a sign that the problem is not yet satisfactorily solved. The persistent problem is that predictable release kinetics, an increased rate but within defined limits, are required to avoid high absorption variability. This paper presents a synthesis of a carbamazepine-β-cyclodextrin inclusion complex (CBZ-β-CD), the characterization of the physical mixture, CBZ, β-CD and the CBZ-β-CD inclusion complex using Fourier transform infrared spectroscopy, scanning electron microscopy, simultaneous thermal analysis and X-ray diffraction, formulation of chewable tablets, determination of the dissolution of carbamazepine in medium containing 1% sodium lauryl sulfate (LSS), and in simulated saliva (SS), mathematical modeling of release kinetics. The kinetics of total CBZ release from tablets containing CBZ-β-CD and super-disintegrant F-Melt in both SS and LSS followed two steps: a burst release in the first minutes and a slower release in intervals up to 60 min. The release in the second phase has been well described by the Higuchi and Peppas models, which advocate a controlled release by combined diffusion and with some phenomena of swelling and relaxation of the matrix generated by the crospovidone component of the F-Melt excipient.

The effect of relative humidity and formulation variables on chewable xylitol-sorbitol tablets

Changing relative humidity levels challenge the manufacturing of chewable xylitol-sorbitol based tablets. The aim of the study is to investigate how the formulation of chewable xylitol-sorbitol tablets affects the properties of the powder blends and the tablets in an environment of different relative humidity levels. In all, 30 batches containing different ratios of sorbitol, xylitol and magnesium stearate were prepared at three different relative humidity levels. Powder blends were made into tablets using an instrumented eccentric tableting machine. To demonstrate the effect of variables on powder blend and tablet properties, multiple linear regression analysis was performed. It was found that xylitol-sorbitol powder blends and tablets benefitted from the large amount of magnesium stearate, and the high lubricant level negatively affected the quality of the tablets only at high relative humidity. In the presence of high environmental humidity, the amount of sorbitol in the powder mixture must be limited in order to prevent sticking whereas at low relative humidity, higher content of sorbitol is needed to decrease the friability of tablets. Results indicate that alternating relative humidity levels truly challenge the production of xylitol-sorbitol based tablets and if the humidity is not controllable, there is a need for additional filler-binders.