Pharmaceutical Gelatin Research Articles

INVESTIGATION OF PROBIOTICS-SORPTION PROPERTIES OF THE COMPOSITION BASED ON POMACE

The use of enterosorbents to relieve intoxication and to increase the content of prebiotics in the body is a topical problem of every second metropolis resident. The pharmaceutical market offers a huge number of enterosorbents, some of which can cause negative consequences (for example, mechanical damage, constipation etc.). The others that are more compatible with the body, for example, pectins, are expensive due to the energy-intensive process of their isolation. We offer a preparation based on pomace powder (60%) with the addition of starch, kaolin and pectin from sea grass eelgrass (Zostera marina) (6%). The powder is obtained by a previously developed and patented method and has an established sufficiently high sorption activity. At the same time, apple pomace also contains pectin, which is a substrate for the growth of beneficial microorganisms living in the colon.
 The article presents the data of a comparative analysis of the sorption activity of the developed powder and a number of enterosorbents offered by the pharmaceutical market in relation to standard test substances: methylene blue and pharmaceutical gelatin. It is shown that the composite enterosorbent obtains effective sorption properties and equals to common sorbents. When dissolved in water, the powder acquires a gel-like consistency that gives it additional therapeutic and preventive properties. The use of apple pomace as a basis enables to reduce the cost of producing expensive pectin and make it more affordable for the population.

Infrared spectroscopic study of the coil-helix transition of highly concentrated gelatin formulations

The aim of this study was to investigate the applicability of ATR-FTIR spectroscopy as an analytical tool to monitor the gel formation of highly concentrated gelatin formulations. Spectral changes induced by the coil-helix transition have been studied and related to the elasticity parameter G′ obtained by oscillatory rheology in simultaneous measurements. A principal component analysis of the amide I band allowed the evaluation of triple helix formation kinetics. It was found that the key frequencies of the amide I band at 1657 and 1612 cm−1 represent the transition of the gelatin molecules from the random coil to the triple helical conformation in the emerging gel. A direct correlation between the conformation of the gelatin molecules and the gel elasticity was obtained for a commercially available pharmaceutical grade limed bone gelatin in concentrations between 20 and 40% w/w. The same was valid upon addition of small gelatin peptides or a helix inhibitor. No such correlation between triple helix content and G′ was found for limed bone gelatins of the same Bloom value but an asymmetric molecular weight distribution with extremely high fractions of high or low molecular weight components. This suggests that early gel elasticity is not solely linked to the triple helix nucleation. Hence, our results indicate that FTIR spectroscopy can be applied to gain a better understanding of the relationship between triple helix content and elastic gel properties of pharmaceutical gelatin capsule shell formulations.

Simultaneous detection of bovine and porcine DNA in pharmaceutical gelatin capsules by duplex PCR assay for Halal authentication

BackgroundIn the pharmaceutical industry, hard- and soft-shelled capsules are typically made from gelatin, commonly derived from bovine and porcine sources. To ensure that pharmaceutical products comply with halal regulations in Muslim countries (no porcine products allowed), development of a valid, reliable, quick, and most importantly, cost-effective tests are of utmost importance.MethodsWe developed a species-specific duplex polymerase chain reaction (PCR) assay targeting 149 bp porcine and 271 bp bovine mitochondrial DNA (mtDNA) to simultaneously detect both porcine and bovine DNA (in one reaction at the same time) in gelatin. Some additional simplex PCR tests (targeting 126 bp bovine and 212 bp porcine mtDNA) and real-time PCR using a commercially available kit (for identification of porcine DNA) were used to verify the selectivity and sensitivity of our duplex PCR. After optimization of DNA extraction and PCR methods, hard/soft pharmaceutical gelatin capsules (containing drug) were tested for the presence of porcine and/or bovine DNA.ResultsDuplex PCR detected the presence of as little as 0.1% porcine DNA, which was more accurate than the commercially available kit. Of all gelatin capsules tested (n = 24), 50% contained porcine DNA (pure porcine gelatin alone or in combination with bovine gelatin).ConclusionsDuplex PCR presents an easy-to-follow, quick, low-cost and reliable method to simultaneously detect porcine and bovine DNAs (>100 bp) in minute amounts in highly processed gelatin-containing pharmaceutical products (with a 0.1% sensitivity for porcine DNA) which may be used for halal authentication.Graphical abstractSimultaneous detection of porcine and bovine DNA in gelatin capsules by duplex PCR

Nanoparticle-enabled wireless monitoring and characterization of physical degradation kinetics in pharmaceutical gelatin films

Degradation kinetics of pharmaceutical excipient films effect their overall performance and drug release profile. Characterizing them is traditionally labor-intensive and time-consuming, requiring spectroscopy or periodic mass measurements. Here we present an alternative rapid technique for electrically (and wirelessly) measuring the polymeric matrix swelling and material degradation in aqueous media for characterizing functional films. The film is loaded with ferromagnetic nanoparticles and used as the core of a planar coil whose resonant frequency is monitored remotely. When placed in an aqueous solution, swelling and dissolution of the film induce contrasting changes in the capacitance and inductance of the coil, respectively, allowing identification of the swelling and dissolution phases. The dissolution profile of iron oxide-loaded gelatin is compared with spectrophotometry data, further demonstrating the technique can distinguish among films with various levels of crosslinking (showing a resonant frequency difference of 116kHz between completely non-crosslinked and fully crosslinked gelatin). The key characteristics of the film degradation kinetics can be captured within 20–30min of data collection.

STUDY OF ORGANOLEPTIC, PHYSICAL-CHEMICAL AND TECHNOLOGICAL PROPERTIES OF THE PLANT ANALOGUES OF PHARMACEUTICAL GELATIN PRODUCTION FOR SOFT CAPSULES

Abstract: Factors causing the urgency of developing technology of capsules based on non-traditional raw materials, which are mainly plant analogues are considered. Carboxymethylcellulose (CMC), starches, agar, hydroxypropyl methylcellulose (HPMC) are those of economic viability due to cheaper raw materials, consumer demand for the encapsulated drugs and biologically active additives (BAA). New different characteristics that satisfy a wide range of consumers, including those who do not use animal products for religious and / or behavioral (vegetarians) reasons are presented. In the course of studies complex characteristics of organoleptic, physical- chemical, optical, buffering, rheological and structural-mechanical properties, chemical reactivity indices of plant analogues of pharmaceutical gelatin, and combinations thereof to produce capsules were determined. The tested plant analogues of pharmaceutical gelatin for capsules exhibit the properties of weak electrolytes. Active amount of titratable groups in plant analogues of pharmaceutical gelatin from agar and HPMC is small, that makes the contribution of these compounds impossible when predicting the properties of the acid-base complex mixtures or solutions. Plant analogues of pharmaceutical gelatin from starches exhibit sufficiently strong buffering properties, the average number of active groups in a 1% starch solution being 1.9 mM, and the solution’s pKa of plant analogues of pharmaceutical gelatin from pectins in the range from 4.3 to 4.9 pH units respectively. Solutions of plant analogues of pharmaceutical gelatin from carrageenans are chemically unstable in the presence of acid in the solution. Acidity tests showed, that among the studied samples of plant analogues of pharmaceutical gelatin from starch all the starch samples proved to have satisfactory characteristics. The complex properties of plant analogues of pharmaceutical gelatin were examined and the possibility of using plant analogues of pharmaceutical gelatin for soft capsules was proved.

Analysis of Cyclosporin A and Main Degradation Impurities by Cyclodextrin–Modified Micellar Electrokinetic Chromatography

Separation of the immunosuppressive drug cyclosporin A (CyA) from the closely related degradation impurities cyclosporin H (CyH, a CyA diastereomer) and isocyclosporin A (IsoCyA) was accomplished by means of cyclodextrin-modified micellar electrokinetic chromatography (CD-MEKC). Heptakis (2,3,6-tri-O-methyl)-β-cyclodextrin (TM-βCD) showed to be an effective modifiers of the sodium dodecyl sulfate (SDS) micellar system, allowing for the CD-MEKC separation of CyA from CyH and IsoCyA. By means of electric current measurements carried out using the capillary electrophoretic apparatus, the critical micelle concentration of SDS in the presence of different neutral cyclodextrins was estimated. Interestingly, it was found that TM-βCD strongly inhibited the micellization of SDS compared to β-, and hydroxypropyl-β-cyclodextrin. This unusual behavior was considered to be a key factor of the specific ability of the methylated cyclodextrin in providing CD-MEKC separation of hydrophobic cyclosporins. The optimized method consisted of: 50 mM sodium dodecyl sulfate (SDS) in 50 mM tetraborate buffer (pH 9.2) supplemented with 15 mM TM-βCD. The electrophoretic runs were performed at 30°C under the application of 22 kV in a fused-silica capillary (50 µm id, 64.5 cm total length, 56 cm length to the detector). The method was validated for linearity of CyA (within 0.25–5.00 mg/mL) and CyH and IsoCyA (within 0.25–5.0%, w/w with respect to CyA), sensitivity (LOQ 5.0 µg/mL), accuracy, and precision. The applicability of the method was proved by analysis of a commercially available pharmaceutical (gelatin capsules).

An enzymic technique for the microbiological examination of pharmaceutical gelatin.

An enzymic technique for the microbiological examination of pharmaceutical gelatin.

New Polymeric Formulation for the Control of Biomphalaria Alexandrina Based on Pharmaceutical Waste Gelatin

New Polymeric Formulation for the Control of Biomphalaria Alexandrina Based on Pharmaceutical Waste Gelatin

Recycling of Pharmaceutical Waste Gelatin for Controlled Release Applications II: A Tri-fluralin Based System

During the latter half of last century, the production and consumption of synthetic plastics and fibers has vastly grown. The plastics wastes have continuously increased over recent decades. Concerns over this have now resulted in mandatory recycling laws and demands for degradable polymers. Management of plastic wastes cannot be treated as an individual problem; it must be considered as an integral part of the global waste management system. The development of recycling processes leading to higher quality recycled products would help the recycling economy. In this study, recycling of pharmaceutical gelatin scraps will be conducted by incorporating them in biodegradable mulching films. The formulation and preparation of these films is described and the effect of different additives on the rate of release of the bioactive agent (trifluralin) is reported. The results showed that the produced films have controlled release properties and the presence of cross-linked agent decreased the release rate of trifluralin.

Recycling of pharmaceutical waste gelatin for controlled‐release applications. I. A 2,4‐dicholorphenoxy acetic acid based system

AbstractGelatin is a natural macromolecular protein. It contains a wide variety of amino acids in its polymer structure, and it is colorless to yellowish, water‐soluble, and tasteless. It is used as a dispersing agent, sizing medium, and coating for photographic films and in pharmaceutical formulations. In this study, biodegradable mulching, based on waste gelatin from pharmaceutical gelatin scraps (derived from pharmaceutical soft gelatin capsule production), was formulated via the casting of water solutions or suspensions into flexible and consistent films. Gelatin was blended with synthetic materials such as poly(vinyl alcohol) and other natural wastes such as sugar cane bagasse and sawdust. To all formulations, 2,4‐dichlorophenoxy acetic acid (2,4‐D) was added as a herbicide. The morphology and mechanical properties of the samples were investigated with scanning electron microscopy and tensile testing, respectively. The results showed that the produced films had controlled‐release properties. The effects of various additives and crosslinking on the films and the release of the herbicide 2,4‐D from the films were also investigated. The introduction of synthetic and natural additives reduced the release rate of 2,4‐D. © 2003 Wiley Periodicals, Inc. J Appl Polym Sci 91: 2313–2319, 2004

Role of collagen hydrolysate in bone and joint disease

Objectives: To review the current status of collagen hydrolysate in the treatment of osteoarthritis and osteoporosis. Methods: Review of past and current literature relative to collagen hydrolysate metabolism, and assessment of clinical investigations of therapeutic trials in osteoarthritis and osteoporosis. Results: Hydrolyzed gelatin products have long been used in pharmaceuticals and foods; these products are generally recognized as safe food products by regulatory agencies. Pharmaceutical-grade collagen hydrolysate (PCH) is obtained by hydrolysis of pharmaceutical gelatin. Clinical studies suggest that the ingestion of 10 g PCH daily reduces pain in patients with osteoarthritis of the knee or hip; blood concentration of hydroxyproline is increased. Clinical use is associated with minimal adverse effects, mainly gastrointestinal, characterized by fullness or unpleasant taste. In a multicenter, randomized, double-blind, placebo-controlled trial performed in clinics in the United States, United Kingdom, and Germany, results showed no statistically significant differences for the total study group (all sites) for differences of mean pain score for pain. There was, however, a significant treatment advantage of PCH over placebo in German sites. In addition, increased efficacy for PCH as compared to placebo was observed in the overall study population amongst patients with more severe symptomatology at study onset. Preferential accumulation of 14C-labeled gelatin hydrolysate in cartilage as compared with administration of 14C-labeled proline has been reported. This preferential uptake by cartilage suggests that PCH may have a salutary effect on cartilage metabolism. Given the important role for collagen in bone structure, the effect of PCH on bone metabolism in osteoporotic persons has been evaluated. Studies of the effects of calcitonin with and without a collagen hydrolysate-rich diet suggested that calcitonin plus PCH had a greater effect in inhibiting bone collagen breakdown than calcitonin alone, as characterized by a fall in levels of urinary pyridinoline cross-links. PCH appeared to have an additive effect relative to use of calcitonin alone. Conclusions: Collagen hydrolysate is of interest as a therapeutic agent of potential utility in the treatment of osteoarthritis and osteoporosis. Its high level of safety makes it attractive as an agent for long-term use in these chronic disorders. Semin Arthritis Rheum 30:87-99. Copyright © 2000 by W.B. Saunders Company

A simplified matrix for making direct cores

This article describes the use of a pharmaceutical gelatin capsule as a matrix for making various posted and nonposted crown substructures. The procedure used for a cast post and core using this matrix is outlined.