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Showing papers in "Drug Development and Industrial Pharmacy in 1997"


Journal ArticleDOI
TL;DR: Some aspects of bioadhesion such as mucus layer, mucoadhesion, and theories ofBioadhesion to explain the adhesion mechanism are described.
Abstract: Mucoadhesion in drug delivery systems has recently gained interest among pharmaceutical scientists as a means of promoting dosage form residence time as well as improving intimacy of contact with various absorptive membranes of the biological system. Besides acting as platforms for sustained-release dosage forms, bioadhesive polymers can themselves exert some control over the rate and amount of drug release, and thus contribute to the therapeutic advantage of such systems. This paper describes some aspects of bioadhesion such as mucus layer, mucoadhesion, and theories of bioadhesion to explain the adhesion mechanism. The factors important to mucoadhesion, the methods used to study bioadhesion, and bioadhesive polymers are described. The methods that evaluate the mucoadhesive dosage forms and finally the bioadhesive drug delivery systems designed for several therapeutic purposes are presented.

430 citations


Journal ArticleDOI
TL;DR: In this article, the authors present a Colonic Drug Delivery System (CDDS) model for colonic drug delivery, which is based on the concept of colonic co-delivery.
Abstract: (1997). Colonic Drug Delivery. Drug Development and Industrial Pharmacy: Vol. 23, No. 9, pp. 893-913.

239 citations


Journal ArticleDOI
TL;DR: An appropriately designed controlled-release drug delivery system can be a major advance towarb solving problems concerning the targeting of a drug to a specific organ or tissue and controlling the release of the drug.
Abstract: An appropriately designed controlled-release drug delivery system can be a major advance towarb solving problems concerning the targeting of a drug to a specific organ or tissue and controlling the...

167 citations


Journal ArticleDOI
TL;DR: The Wurster-based coating process does not contain any fluid-bed regions in the traditional sense, as it is a circulating fluidbed process as mentioned in this paper, and four different regions within the equipment can be identified: the upbed region, the expansion chamber, the downbed region and the horizontal transport region.
Abstract: The Wurster-based fluid-bed coating process is often treated as just another fluid-bed coating process. However, there are significant differences between the two types of fluid-bed coatings. The Wurster-based coating process does not contain any fluid-bed regions in the traditional sense, as it is a circulating fluid-bed process. Four different regions within the equipment can be identified: the upbed region, the expansion chamber, the downbed region, and the horizontal transport region. The size of these regions is determined by the dimensions of the coating apparatus. Part of the upbed region constitutes the coating zone where the spray mist hits the substrate (the material that is going to be coated). The coating process consists of three phases: the start-up phase, the coating phase, and the drying/cooling phase. During the coating phase, several processes take place simultaneously. They are: atomization of the film solution/suspension, transport of the film droplets to the substrate, adhesio...

111 citations


Journal ArticleDOI
TL;DR: The first part of the review deals with some general aspects of irradiation treatment and its use in the sterilization of pharmaceuticals and the information available in the literature on polymeric biomatenals used for carriers after irradiation sterilization.
Abstract: A survey was made of the influence of irradiation sterilization on relevant natural, semisynthetic, and synthetic polymers used for drug carrier system. The first part of the review deals with some general aspects of irradiation treatment and its use in the sterilization of pharmaceuticals. The second part reviews the information available in the literature on polymeric biomatenals used for carriers after irradiation sterilization. The influence of irradiation sterilization has been described for polyester, poly(ortho ester), different synthetic hydrogels, silicone derivatives, cellulose-derivatives, hyaluronic acid, different glucosides, collagen, and gelatine. Also, some limitations concerning the use of high-energy radiations for sterilization are given.

111 citations


Journal ArticleDOI
TL;DR: In this paper, a cross-linked poly (vinyl alcohol) was developed and their properties were evaluated as a controlled-release oral solid dosage form and the concentration of glutaraldehyde involved in cross-linking was directly proportional to the compactness of the three-dimensional networks of the crosslinked poly.
Abstract: Hydrogels of cross-linked poly (vinyl alcohol) (PVA) were developed and their properties were evaluated as a controlled-release oral solid dosage form. The concentration of glutaraldehyde involved in cross-linking is directly proportional to the compactness of the three-dimensional networks of the cross-linked PVA. The theoretical calculations reveal that the release of diltiazem HCl from PVA could be described by the combination of Fickian and diffusion-controlled models. The confirmation of cross-linking was done by differential scanning calorimetry and infrared spectroscopy. The microparticles show lower percentage compressibility but good flowability; hence a capsule dosage form was thought to be suitable. The toxicity level of PVA was confirmed to be 10 g/kg body weight. The microparticle formulation was optimized with respect to size distribution and increased drug loading. The microparticles were physically evaluated with respect to bulk density, angle of repose, and percent compressibility...

110 citations


Journal ArticleDOI
TL;DR: The effects ofcyclodextrins and aqueous cyclodextrin eye drop formulations on the ocular bioavailability of drugs are reviewed.
Abstract: Cyclodextrins are oligosaccharides which form a new group of pharmaceutical excipients. Cyclodextrins have been added to aqueous eye drop preparations to solubilize lipophilic water-insoluble drug, to increase the chemical stability of drugs, or to reduce local drug irritation in the eye. Hydrophilic cyclodextrins, such as 2-hydroxypropyl-β-cyclodextrin, have been shown to be nontoxic to the eye and are generally well tolerated in aqueous eye drop formulations. However, improper formulation of aqueous cyclodextrin containing eye drop solutions can reduce the topical availability of the drug molecule. This paper reviews the effects of cyclodextrins and aqueous cyclodextrin eye drop formulations on the ocular bioavailability of drugs.

108 citations


Journal ArticleDOI
TL;DR: In this paper, an attempt was made to prepare chitosan microspheres by an emulsion-phase separation technique but without the usual use of glutaraldehyde as a cross-linking agent.
Abstract: An attempt was made to prepare chitosan microspheres by an emulsion-phase separation technique but without the usual use of glutaraldehyde as a cross-linking agent. Instead, ionotropic gelation was employed in a w/o emulsion. The effect of formulation factors was examined. The results showed that microspheres so formed were spherical, free-flowing, and had smooth surfaces. The rate of addition of counterions was important. Gelation of chitosan droplets should take place before the destabilizing effect of the counterions occurred. This effect is associated with the increase in aqueous phase volume when the counterion solution is incorporated.

79 citations


Journal ArticleDOI
TL;DR: In this article, a factorial-designed study has been performed to investigate the effect of two formulation variables and three processing variables on size, size distribution, and friability of pellets made in a rotary processor by the wet granulation technique.
Abstract: A factorial-designed study has been performed to investigate the effect of two formulation variables and three processing variables on size, size distribution, and friability of pellets made in a rotary processor by the wet granulation technique. The first are the microcrystalline cellulose content and the ratio of the amount of added water to the amount of microcrystalline cellulose in the powder mixture; the latter are the rotor speed, the spheronization time after water addition, and the water addition rate. Both formulation variables and the three processing variables have a major influence on pellet size and percentage loss in weight in the friability test. With the exception of the spheronization time, increasing an independent variable results in a wider size distribution. The wet granulation technique in the rotary processor has been judged to be a critical technique. However, if all variables are fully controlled, rather good reproducibility can be obtained

77 citations


Journal ArticleDOI
Anna-Lena Ungell1
TL;DR: In Vitro Absorption Studies and their Relevance to the GI Tract as mentioned in this paper, the authors discuss the importance of the GI tract in drug development and industrial pharmacology.
Abstract: (1997). In Vitro Absorption Studies and Their Relevance to Absorption from the GI Tract. Drug Development and Industrial Pharmacy: Vol. 23, No. 9, pp. 879-892.

76 citations


Journal ArticleDOI
TL;DR: In this paper, the effects of hydrophilic and hydrophobic polymers, incorporated in matrices containing soluble (propranolol HCl) or less soluble (flurbiprofen) drugs, on swelling and release kinetics were investigated.
Abstract: Polymers, and particularly hydrogels, are becoming very popular in formulating controlled-release tablets because they are excellent drug carriers The effects of hydrophilic and hydrophobic polymers, incorporated in matrices containing soluble (propranolol HCl) or less soluble (flurbiprofen) drugs, on swelling and release kinetics were investigated The results indicate that swelling and release profiles were affected by the amount of ingredients, the characteristics of the polymer, and the drug substances incorporated in the matrices Swelling may influence the release rate of the drugs from the matrices The data obtained from the in vitro dissolution study were evaluated on the basis of a theoretical dissolution equation, by linear transformation of the dissolution curve, and by the Peppas equation The release mechanisms appeared complex and are affected by the composition of the matrix

Journal ArticleDOI
TL;DR: In this article, a self-emulsifying system using hydrophile-lipophile balance (HLB), fatty acid glycerides, and a co-emulsion with varying fatty acid (C8-C18) chain length was evaluated.
Abstract: Dosage forms containing a self-emulsifying system have shown significant promise in improving the in vitro dissolution rate and oral absorption of lipophilic drugs. In such a system, a surfactant, or a surfactant plus medium chain monoglyceride (co-emulsifier), is added to a lipophilic vehicle (oil) containing dissolved drug. In the present study, surfactants with different hydrophile-lipophile balance (HLB), fatty acid glycerides (co-emulsifiers) with varying fatty acid (C8-C18) chain length, and lipophilic vehicles (oils) containing different fatty acid (C8-C18) compositions were evaluated for their effectiveness in producing self-emulsifying systems. nis investigation showed that the HLB of the surfactant, as well as the fatty acid chain length of the monoglyceride have a significant effect on the performance of the self-emulsifying system; a surfactant with an HLB in the range of 10–15 and a monoglyceride of medium chain fatty acid (C8-C10) were most effective. Also, there are certain critical...


Journal ArticleDOI
TL;DR: In this paper, four different tablet shapes (round, oval, capsule, and large oval) were coated in a small-scale coating pan at three different pan rotational speeds.
Abstract: Four different tablet shapes (round, oval, capsule, and large oval) were coated in a small-scale coating pan at three different pan rotational speeds. The coating film thickness was measured on the top face, the edge of the land, and the belly band of each tablet shape. The results showed that tablet shape directly influences intra-tablet coating uniformity (uniformity decreasing from round, oval, capsule, to large oval). In almost all cases, coating uniformity increased with pan speed.

Journal ArticleDOI
TL;DR: In this article, solid dispersions of carbamazepine (CBZ) using polyethylene glycol (PEG) 4000 and PEG 6000, measure the dissolution, and characterize using x-ray diffraction, DSC, and IR spectroscopy.
Abstract: The objective of this study was to prepare solid dispersions of carbamazepine (CBZ) using polyethylene glycol (PEG) 4000 and PEG 6000, measure the dissolution, and characterize using x-ray diffraction, DSC, and IR spectroscopy. Solid dispersions were prepared by either the melt or solvent methods. A comparison of dissolution profiles of the solid dispersions indicated dramatic increases in the rate and extent of CBZ dissolution from solid dispersions. The dissolution of physical mixtures provided evidence of the solubilizing effects of PEGs. Untreated CBZ exhibited 10.09 ± 2.92% dissolution in 10 min (Dl0); whereas, a melt of PEG 6000 and CBZ at a ratio of 6: 1 provided 36.49 ± 1.97% and a melt of PEG 4000 and CBZ at a ratio of 6: 1 gave a D10 of 23.59 ± 1.45%. The rate and extent of dissolution of CBZ were significantly higher when blends of the PEGs were employed to prepare solid dispersion. The melt method provided significantly higher rate and extent of dissolution of CBZ than the solvent meth...

Journal ArticleDOI
TL;DR: In this article, the authors used a Roto-processor to prepare inert nonpareils with phenylpropanolamine hydrochloride and coated with ethyl cellulose polymeric dispersion (Surelease®).
Abstract: The main objective of this study was to prepare pellets in a Roto-processor using the powder-layering process onto inert nonpareils and to evaluate the applicability of the Roto-processor setup for film coating. Nonpareils were loaded with phenylpropanolamine hydrochloride and coated with ethyl cellulose polymeric dispersion (Surelease®). The drug loading was analyzed to test the eficiency of powder layering. The effect of polymer level on the drug release from the pellets and the pore size distribution in the membrane were studied. The yields for powder layering were greater than 90%. The dissolution studies on the Blm-coated pellets showed sustained release over a 10-hr period. The time required for 50% of drug release increased and the mean pore diameter decreased with an increase in polymer coating.

Journal ArticleDOI
TL;DR: The paracetamol formulations were prime examples of high-dose drug substances with particularly poor granulating and tabletting properties, well suited to reveal differences between the binders.
Abstract: Based on an analysis of model granulates and tablets, a comparison was made of the effectiveness of the binders PVP K30 PH, Cellulose HP-M 603, Lycatab DSH, Lycatab PGS, and L-HPC (type LH 11). A h...

Journal ArticleDOI
TL;DR: In vivo evaluation of the buccal tablet in healthy human volunteers and its comparison with a marketed troche formulation revealed that the muco-adhesive tablet produced more uniform and effective salivary drug levels with adequate comfort, taste, and non-irritancy over a period of 6 hr.
Abstract: Muco-adhesive erodible buccal tablets of clotrimazole were formulated using a combination of bio-adhesive polymers like Carbopol-974P (CP-974P) and hydroxypropylmethylcellulose-K4M (HPMC-K4M), and soluble excipients like polyethylene glycol-6000 and mannitol. Increasing the concentration of CP-974P was found to increase the in vitro adhesion time as well as the bio-adhesive strength of the formulations. A combination of 7.5% of CP-974P and 42.5% of HPMC-K4M along with the soluble excipients in the erodible matrix, was found to release the drug for up to 3 hr, in vitro without getting dislodged. The drug released was found to be microbiologically active against Candida albicans. In vivo evaluation of the buccal tablet in healthy human volunteers and its comparison with a marketed troche formulation revealed that the muco-adhesive tablet produced more uniform and effective salivary drug levels with adequate comfort, taste, and non-irritancy over a period of 6 hr.

Journal ArticleDOI
TL;DR: In this paper, solid dispersions of a very slightly water-solubte drug, ursodeoxycholic acid (UDCA), were prepared using urea, mannitol, and PEG 6000 as a carrier, and the solubility of UDCA was determined in water-ethanol (1:1) mixed solvent.
Abstract: Solid dispersions of a very slightly water-solubte drug, ursodeoxycholic acid (UDCA), were prepared using urea, mannitol, and PEG 6000 as a carrier, and the solubility of UDCA was determined in water-ethanol (1:1) mixed solvent as a function of UDCA-carrier ratio The solubility of UDCA was slightly improved when urea or PEG 6000 was used as a carrier The powder x-ray diffraction measurements revealed that UDCA did not exist in the crystalline state in the solid dispersions Differential scanning calorimetry (DSC) studies showed that UDCA was able to dissolve in the melt of urea, mannitol, and PEG 6000 The effect of carriers of solid dispersions on the UDCA dissolution rate was examined The dissolution rate of UDCA was markedly increased from the solid dispersions of urea, PEG 6000, and mannitol, respectively

Journal ArticleDOI
TL;DR: It is demonstrated that terminal filtration is a feasible proscribed process and can retain 100% Pseudomonas diminuta organisms under simulated worst-case process conditions.
Abstract: A Nano Crystal™ dispersion of the iodinated x-ray contrast agent iodipamide was prepared by wet milling the drug substance in the presence of Pluronic® F127 stabilizer. The mean particle size of the formulation was 98 nm and all drug particles in the formulation were smaller than 220 nm as determined by dynamic light scattering. Approximately 1 liter of dispersion was filtered through a sterile 0.2-μm disposable capsule filter (Supor® 200 DCF™, 0.I m2 effective filtration area [EFA], Gelman Sciences) to condition the capsule. No drug concentration or size distribution changes were detected after the filtration process. The microbiological validation tests were performed using Pseudomonas diminuta organisms to challenge the capsule under simulated worst-case process conditions. The results showed that the Supor 200 DCF was able to retain 100% Pseudomonas diminuta organisms (≥107 organisms per cm2 of effective filtration area). Thus, this study demonstrated that terminal filtration is a feasible pro...

Journal ArticleDOI
TL;DR: In this article, the inclusion complex formation between oxazepam (Ox) and heptakis (2,6-di-O-methyl)-β-cyclodextrin (DIMEB) was studied in solution by solubility and ultraviolet spectroscopy methods, and in the solid state by differential scanning calorimetry, scanning electron microscopy, and powder x-ray diffractometry.
Abstract: The inclusion complex formation between oxazepam (Ox) and heptakis (2,6-di-O-methyl)-β-cyclodextrin (DIMEB) was studied in solution by solubility and ultraviolet spectroscopy methods, and in the solid state by differential scanning calorimetry, scanning electron microscopy, and powder x-ray diffractometry. The apparent stability constant, Kc, calculated by solubility and spectral data, was estimated as 642 and 588 M-1, respectively. The solid complexes have been prepared by kneading and spray-drying techniques. The dissolution rate studies reveal that the better dissolution behavior corresponded to the spray-dried systems.

Journal ArticleDOI
TL;DR: In this article, the dissolution rate of coevaporates of paracetamol and rifampicin with Eudragit polymers of different natures (anionic, cationic, and zwitterionic) was determined.
Abstract: Coevaporates of paracetamol and rifampicin with Eudragit polymers of different natures (anionic, cationic, and zwitterionic) were prepared. Determination of dissolution rate of these coevaporates in dissolution media simulating those of the gastrointestinal tract (GIT) revealed that the release rate of paracetamol is retarded from all the coevaporates studied. In this respect, Eudragit L100-SS shows the highest sustainment of drug release, while Eudragit E100 shows the lowest. Conversely, the release of rifampicin from its coevaporates with the anionic Eudragit S100 polymer is more retarded than the corresponding coevaporate with the zwitterionic Eudragit RL100 or from coevaporates with equal mixtures of the two polymers.Increasing the polymer weight fraction in rifampicin coevaporates with Eudragit S100 up to 0.5 resulted in a corresponding decrease in the dissolution rate. However, beyond this weight fraction, the polymer effect on the dissolution rate of the drug becomes minimized. The results ...

Journal ArticleDOI
TL;DR: In-vivo studies showed that an erythrocyte-based delivery system has potential to increase drug concentration many fold a...
Abstract: Rat erythrocytes were loaded with isoniazid and magnetite by the preswell technique. Various parameters such as drug concentration, magnetite concentration, and volume of aqueous solution were optimized to study the maximum loading of drug into erythrocytes (67.2 ± 1.6%). The loaded cells were characterized for drug and magnetite content, hemoglobin content, percent cell recovery, morphology, osmotic fragility, turbulence shock, in-vivo drug and hemoglobin efflux, and magnetic responsiveness. No appreciable detrimental effect on cell morphology, osmotic fragility, and turbulence shock in comparison to normal cells was noted. However, drug and magnetite showed little detrimental effect on cells. Drug release from these systems followed approximately zero-order kinetics. Re drug- and magnetite-loaded cells effectively responded to an external magnetic field of 8.0 ± 1.0 K.Oe. The in-vivo studies showed that an erythrocyte-based delivery system has potential to increase drug concentration many fold a...

Journal ArticleDOI
TL;DR: In this paper, differential scanning calorimetry (DSC) was used to follow the time-dependent physical and morphological changes within the hydrated and dried microparticles, to determine the physical state of the absorbed water, and to detect penetration of buffer ions into the particle bulk.
Abstract: Poly (D, L-lactide) (PLA) and poly (D, L-lactide-co-glycolide) (PLGA) microparticles were evaluated for their in vitro degradation behavior in 0.1 M phosphate buffer pH 7.4 at 37°C. The influence of polymer characteristics, particle size, and preparation technique was investigated. Differential scanning calorimetry (DSC) was used to follow the time-dependent physical and morphological changes within the hydrated and dried microparticles, to determine the physical state of the absorbed water, and to detect penetration of buffer ions into the particle bulk. Results were compared with degradation kinetics obtained by gel permeation chromatography (GPC) and gravimetry. The latter revealed triphasic degradation profiles for R 202 and RG 755 microparticles with a mean particle size of 55 μm and 60 μm, respectively. An induction period was followed by a period of accelerated ester cleavage pre-onset of erosion and a final period of slow ester cleavage post-onset of erosion. According to DSC data the indu...

Journal ArticleDOI
TL;DR: Differential scanning calorimetry (DSC) analyses showed that the formation of the calcium alginate gel structure was impeded in the presence of propranolol molecules.
Abstract: The interaction of propranolol hydrochloride with alginate molecular chains in calcium alginate beads was investigated. The drug was either incorporated into formed calcium alginate gel beads or incorporated simultaneously with the gelation of alginate beads by Ca2+. Bed produced by the former method had a higher drug content and lower Ca2+ level compared to those prepared by the latter method. The extent of drug binding to the alginate molecules increased with decreasing Ca2+ levels in the beads, indicating that propranolol and Ca2+ shared common binding sites in the alginate chains, me appearance of the beads and the molphology of the alginate polymer in the beads were affected by the amounts of both propranolol and Ca2+ in the beads. Differential scanning calorimetry (DSC) analyses showed that the formation of the calcium alginate gel structure was impeded in the presence of propranolol molecules.

Journal ArticleDOI
TL;DR: HLC analysis indicated that TRH extracted from buccal patches thermally stressed at 40°, 55°, and 70°C showed negligible degradation after 6 months, while an aqueous TRH solution stored at 70° C showed degradation of TRH as soon as 10 days following incubation at this temperature.
Abstract: Mucoadhesive buccal patches were evaluated in vitro and in vivo using rats for release of thyrotropin-releasing homne (TRH). TRH (10% w/w) was incorporated into mucoadhesive buccal patches that were custom coformulated with silicone and organic polymers (Dow Coming, Midland, MI) and its release profile was characterized in vitro using a modified Franz diffusion cell. TRH released into pH = 7.0 phosphate buffered saline at 37°C under sink conditions was detected using high-performance liquid chromatography (HPLC). Release of TRH in vitro from the buccal patches was rapid during the first 2 hr, with 51% of the total amount of TRH incolporated into the patches released after 24 hr. HPLC analysis indicated that TRH extracted from buccal patches thermally stressed at 40°, 55°, and 70°C showed negligible degradation after 6 months. In contrast, an aqueous TRH solution stored at 70°C showed degradation of TRH as soon as 10 days following incubation at this temperature. TRH patches placed on the buccal mu...

Journal ArticleDOI
TL;DR: The compaction properties of microcrystalline cellulose (MCC) from 6 different sources were investigated and compared using tableting indices as mentioned in this paper, and it was found that Avicel and Emcocel products demonstrated the most similarities based on tableting index.
Abstract: The compaction properties of microcrystalline cellulose (MCC) from 6 different sources were investigated and compared using tableting indices. The 50-μm and 100-μm grades were studied in order to determine lot-to-lot variability within a source, variability between sources, and the influence of storage conditions on the compaction properties of MCC. Two lots of each grade of MCC were obtained from each source and tested as received. It was found that the Avicel and Emcocel products demonstrated the most similarities based on tableting indices. Significant lot-to-lot differences in the tableting indices were observed for Fibrocel, Omnicel, and Spectrum MCC products. The brittle fracture index was low for all products tested and not significant. Storage of compacts at elevated humidity conditions prior to determining the tableting indices decreased the magnitude of the tensile strength, dynamic indentation hardness, and bonding index. Particle size analysis revealed differences between the labeled m...

Journal ArticleDOI
TL;DR: In this article, the effects of various polymers on the release of diclofenac sodium from their matrices have been evaluated and the best-fit release kinetics with the highest correlation coefficients was achieved with the Higuchi's plot followed by the zero-order.
Abstract: The effects of various polymers on the release of diclofenac sodium from their matrices have been evaluated. In vitro release profiles of diclofenac sodium from ethylcellulose and hydroxypropylmethylcellulose (HPMC) K4M matrices showed that decreasing the concentration of ethylcellulose and increasing the concentration of HPMC K4M resulted in an increase in the release rate of diclofenac sodium. An increase in the amount of lactose in matrix resulted in an increase in the release rate of diclofenac sodium. It is suggested that the use of ethylcellulose or Precirol containing relatively large percentage concentrations of lactose in matrices will not provide zero-order release of diclofenac sodium from matrices. The best-fit release kinetics with the highest correlation coefficients was achieved with the Higuchi's plot followed by the zero-order. A straight line relationship was established bemeen the T50% and the ratio of HPMC K4M to diclofenac sodium.

Journal ArticleDOI
TL;DR: Evaluated the factors that influence the release of atenolol, a cardioselective p blocker, from biconvex using bilayered, osmotically controlled tablets coated with a semipermeable membrane of cellulose acetate.
Abstract: Conventional dosage forms are disadvantageous for drugs having short half-lives because of cyclic under- or overdosing and problems of patient compliance. The matrix or reservoir type of controlled-release dosage form provides an alternative. However, bioavailability fluctuations due to gastric pH variations continue to be a problem for many drug candidates. Osmotically controlled drug delivery systems provide a means of eliminating the effect of pH on drug release. However, the literature information is very limited for the effects of formulation variables and other process variables on the release kinetics of drugs from osmotically controlled systems. The objective of this study was to evaluate the factors that influence the release of atenolol, a cardioselective p blocker, from biconvex. bilayered, osmotically controlled tablets coated with a semipermeable membrane of cellulose acetate. Coating was achieved using a Uni-Glatt fluidized-bed coater. Orifices were drilled for drug release and a sev...

Journal ArticleDOI
TL;DR: In this paper, a biodegradable, nontoxic polymer was introduced as a new disintegrant for pharmaceutical dosage forms, which is a linear anionic polysaccharide approved by the U.S. Food and Drug Administration (FDA).
Abstract: The current research paper introduces a biodegradable, nontoxic polymer as a new disintegrant for pharmaceutical dosage forms. Gellan gum is a linear anionic polysaccharide approved by the U.S. Food and Drug Administration (FDA) for industrial use as a food additive. Experiments were carried out to evaluate the disintegrant property of gellan gum by taking ibuprofen as a model drug. The study included determination of optimum disintegrant concentration, effect of various binders, and suitable mode of incorporation of the disintegrant. The newly investigated disintegrant was compared with the conventional disintegrants to determine its relative efficiency.