scholarly journals Embedded 3D Printing of Novel Bespoke Soft Dosage Form Concept for Pediatrics

Pharmaceutics ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 630 ◽  
Author(s):  
Katarzyna Rycerz ◽  
Krzysztof Adam Stepien ◽  
Marta Czapiewska ◽  
Basel T. Arafat ◽  
Rober Habashy ◽  
...  

Embedded three-dimensional printing (e-3DP) is an emerging method for additive manufacturing where semi-solid materials are extruded within a solidifying liquid matrix. Here, we present the first example of employing e-3DP in the pharmaceutical field and demonstrate the fabrication of bespoke chewable dosage forms with dual drug loading for potential use in pediatrics. LegoTM-like chewable bricks made of edible soft material (gelatin-based matrix) were produced by directly extruding novel printing patterns of model drug ink (embedded phase) into a liquid gelatin-based matrix (embedding phase) at an elevated temperature (70 °C) to then solidify at room temperature. Dose titration of the two model drugs (paracetamol and ibuprofen) was possible by using specially designed printing patterns of the embedded phase to produce varying doses. A linearity [R2 = 0.9804 (paracetamol) and 0.9976 (ibuprofen)] was achieved between percentage of completion of printing patterns and achieved doses using a multi-step method. The impact of embedded phase rheological behavior, the printing speed and the needle size of the embedded phase were examined. Owning to their appearance, modular nature, ease of personalizing dose and geometry, and tailoring and potential inclusion of various materials, this new dosage form concept holds a substantial promise for novel dosage forms in pediatrics.

2018 ◽  
Vol 1 (2) ◽  
pp. 49-58
Author(s):  
Shubhendra Jha ◽  
Sheo Datta Maurya

Semisolid preparations for external application to skin have gained much demand, since it is easily absorbed through the skin layers. Many novel topical dosage forms have been discovered, among which organogels appears to play an important role. Interest in organogels has increased in a wide variety of fields including chemistry, biotechnology and pharmaceutics. Organogels are thermodynamically stable, biocompatible, isotropic gel, which not only give localized effect, but also systemic effect through percutaneous absorption. Organogels are semi-solid systems, in which an organic liquid phase is immobilized by a three-dimensional network composed of self assembled, intertwined gelator fibers. The apolar phase gets immobilized within spaces of the three-dimensional networked structure formed due to the physical interactions amongst the self assembled structures of compounds regarded as gelators. Organogels have been explored as matrices for the delivery of bioactive agents. Compared to conventional topical dosage forms, these novel formulations are found to be more advantageous and efficient. In future, organogels can give way to many promising discoveries in the field of topical dosage forms. The current review aims at giving an idea about organogels, its applications and importance in topical delivery.


Author(s):  
Amit Verma ◽  
Neetu Sachan ◽  
Anurag Verma

Karaya gum (KG) is one of the least soluble of the gums. It does not dissolve in water to give a clear solution but instead absorbs water rapidly to form viscous colloidal sols. Carboxymethylation of Karaya gum is expected to improve its aqueous solubility and gelling behavior. Another objective of the research is to evaluate the potential of carboxymethylated Karaya gum (CMKG) as drug release modulator (in acidic dissolution medium) when combined with HPMC K15M based polymeric matrices bearing Propranolol HCl. In the present study, KG was carboxymethylated using Williamson Ether synthesis. FTIR spectroscopy confirmed the formation of CMKG. The prepared CMKG was used in conjunction with HPMC K15M as a polymer matrix in the formulation capsule dosage form, using Propranolol HCl as model drug. The filled capsules were then coated with Gelucire 43/01 to convert them into hydrodynamically balanced (HBS) capsule dosage form. Dextrose & fructose were also added to the drug-polymer mix as osmogen to facilitate the drug release. The degree of substitution of CMKG was found to be 0.87. HBS capsule dosage forms remained buoyant on 0.1 HCl for up to 6 hr, the buoyancy was attributed to the Gelucire 43/01 coating around the capsule shell. From the experimentation it was observed that CMKG, when mixed with HPMC K15M at 1:3 ratios, extended the release of model drug from HBS capsule dosage forms in 0.1 HCl. At CMKG: HPMC K15M ratio 2:1, release of Propranolol Hydrochloride from hydrodynamically balanced (HBS) capsules revealed fast drug release in 0.1 HCl. From the observations it is evident that KG is amenable to carboxymethylation to form CMKG. It is also evident that it is advantageous to combine CMKG with HPMC K15M as release modulator to retard the release of Propranolol HCl in acidic dissolution medium.


Author(s):  
Chinmoy Bhuyan ◽  
Dipankar Saha ◽  
Bipul Rabha

The method of applying prescription dosage forms to the skin for direct treatment of a cutaneous disorder is known as a topical drug delivery system. Topical gels are semisolid dosage forms in which a liquid phase is constrained within a three-dimensional polymeric matrix derived from natural or semi-synthetic sources with high physical or chemical cross-linking. Because of their intermediate behavior between solid and liquid materials, topical gels are an excellent candidate for transdermal drug delivery. Clinical evidence indicates that topical gel is a safe and effective treatment choice for the management of skin-related diseases, especially when used for local action to avoid the side effects of other conventional dosage forms. Gels, cream, ointment, and paste are the most commonly used semi-solid formulations for topical drug delivery. Gels are colloids in which the liquid medium has thickened to the extent that it behaves like a solid. Since topical gel formulations are less greasy and can be quickly removed from the skin, they offer better drug delivery. In comparison to cream, ointment, and paste, gel formulations have improved application properties and consistency. This article aims to review the principles and recent developments in topical gels, including classification, methods of preparation, applications, and so on.


2021 ◽  
Vol 125 (3) ◽  
pp. 13-22
Author(s):  
Arsenii Kondratskyi ◽  
Olena Glushchenko ◽  
Tetiana Butkevych

The occurrence of superficial wounds remains one of the most significant problems all the time among different types of household injuries. Up to 40 % persons annually have such damages of the skin like abrasions, scratches, cracks, suppurations, cuts, bedsores, and others. The problem of choosing a suitable drug arises acutely, since most pharmacists consider the issue of treatment by themselves. Patient’s referral to hospital departments for doctors advise remains minimal. Pharmacy specialists carry out pharmaceutical care and perform a personal analysis due to the given initial information about the mechanism, place of occur, size of wound and stage of the process of wound healing. Considering previous experience in fulfilling customer needs, they select optimal remedy, determine the majority of choice and thus, may be identified as the sales leaders. As for January 2021, the range of topical drugs used for the treatment of wounds numbered 270 trade names according to the State registry of medicines of Ukraine. They included 62 types of active pharmaceutical ingredients. Antimicrobial (antiseptic), anti-inflammatory, decongestant, protective and emollient action properties are underlined in their pharmaceutical inserts. It is similar for most of the medicines that are available on the Ukrainian pharmaceutical market. After all, their effectiveness to satisfy a patient need is as different as the price point. The choice of the optimal in composition and rational in the dosage form causes certain difficulties among the available wide range of medicines. Registrated semi-solid wound-healing drugs are represented by three groups of ATC classification: D03 – drugs for wounds and ulcers, D06 – antibiotics and chemotherapeutic drugs for use in dermatology, D08 – antiseptic and disinfectant drugs (table 1). Ointments predominate among semi-solid dosage forms with range 67.3 %, creams  –26.5 %, gels – 10.2 %, liniments – 6.1 %, and jellies only 2.0 % of the market. 59.2 % of semi-solid wound-healing drugs are produced by domestic enterprises, and 40.8 % – by foreign manufacturers. The recommendations for the use of semi-solid drugs were distributed as follows: for the first phase of wound process – 48.9 %, for the first and second phases – 12.2 %, for the second phase – 10.2 %, for the second and third phases – 26.4 %, for the third phase – 2.0 %. The article summarizes the results of a questionnaire of pharmaceutical specialists on the available and free sale wound-healing medicines among registered on the Ukrainian market, that are most promoted and recommended. The purpose of our work was to single out available and free sale wound-healing medicines among registered on the Ukrainian market, that are most promoted and recommended by pharmaceutical specialists. This would help to highlight the real picture of sales, to analyze the components of leading products and, as a result of additional research, to propose a model for the complex pharmaceutical development of a new wound-healing medicine in a rational dosage form with safe and effective active ingredients of plant origin, and, consequently, competitive for pharmaceutical manufacturers. The list of registered medicines was composed in accordance with the data from the State Register of Medicines of Ukraine (registrated trade names). The total number of respondents was 176. Questionnaire survey was the main method of information’s collecting: 46 respondents were interviewed individually, 130 persons of the target audience – by electronic form. Questionnaire contained the same questions for the individual survey and online one. Questionnaire contained particular situational tasks and questions related to the practical experience of the pharmaceutical specialists: 12 questions, among which 5 questions provided an answer in detail. Whole data was analyzed systematically and statistically. 342 reviews on 36 medicines trade names were received while answering the question about the drug’s recommendation for quick healing of abrasions and scratches. Various drugs promoting rapid injury healing («Bepanten®» ointment, «Levomekol» ointment, «Pantestin-Darnitsa®» gel and «Riativnyk®» cream) determined in the most mentioned requests. We found out that most pharmaceutical specialists chose semi-solid dosage forms containing dexpanthenol for light burn wounds healing («Bepanten®» cream and ointment, «D-panthenol», «Pantecream», «Pantexol-Jadran», «HepiDerm-Zdorovye»). Pharmaceutical specialists recommend «Contractubex®» and «Solcoseryl» mostly to improve wound healing and minimizing the development of a cosmetic scar. Only 1/3 of respondents would recommend to a pharmacy visitor to exam skin defect by doctor or cosmetician and get reliable advice. The recommendations of pharmaceutical specialists for shallow cuts were predominantly determined by antiseptic drugs – most of them chose iodine solutions. 264 reviews were received for 32 trade names of medicines as effective treatment for bedsores. Respondents preferred zinc oxide preparations usage. According to the investigation, the opinions of the interviewed pharmaceutical specialists were focused on the semi-solid dosage forms (ointments, creams etc) for various wound care (abrasions and scratches, burns, scars, bedsores). Dosage forms of medicines for the treatment of cut wounds were an exception. Solutions and new kind of plasters – Skin glue, were the drugs of choice in this group. Phytomedicines practically did not appear among the respondents answers.


2019 ◽  
Vol 16 (5) ◽  
pp. 461-471
Author(s):  
Chiara G.M. Gennari ◽  
Francesca Selmin ◽  
Paola Minghetti ◽  
Francesco Cilurzo

Medicated foams and film forming systems are dosage forms formulated to undergo a controlled metamorphosis when applied on the skin. Indeed, due to the presence of propellant or a particular air-spray foam pump, a liquid can generate foam when applied on the stratum corneum, or a liquid or conventional dosage form can form on the skin a continuous film as a consequence of the solvent evaporation. Thanks to these controlled modifications, the drug thermodynamic activity increases favoring the skin penetration and, therefore, the bioavailability with respect to conventional semi-solid and liquid dosage forms. Furthermore, the available clinical data also evidence that these dosage forms improve the patient’s compliance. The main formulative aspects of medicated foams and film forming systems are reviewed with the aim to underline the possible advantages in terms of biopharmaceutical performances and patient’s adherence.


Author(s):  
Halit Dogan ◽  
Md Mahbub Alam ◽  
Navid Asadizanjani ◽  
Sina Shahbazmohamadi ◽  
Domenic Forte ◽  
...  

Abstract X-ray tomography is a promising technique that can provide micron level, internal structure, and three dimensional (3D) information of an integrated circuit (IC) component without the need for serial sectioning or decapsulation. This is especially useful for counterfeit IC detection as demonstrated by recent work. Although the components remain physically intact during tomography, the effect of radiation on the electrical functionality is not yet fully investigated. In this paper we analyze the impact of X-ray tomography on the reliability of ICs with different fabrication technologies. We perform a 3D imaging using an advanced X-ray machine on Intel flash memories, Macronix flash memories, Xilinx Spartan 3 and Spartan 6 FPGAs. Electrical functionalities are then tested in a systematic procedure after each round of tomography to estimate the impact of X-ray on Flash erase time, read margin, and program operation, and the frequencies of ring oscillators in the FPGAs. A major finding is that erase times for flash memories of older technology are significantly degraded when exposed to tomography, eventually resulting in failure. However, the flash and Xilinx FPGAs of newer technologies seem less sensitive to tomography, as only minor degradations are observed. Further, we did not identify permanent failures for any chips in the time needed to perform tomography for counterfeit detection (approximately 2 hours).


Author(s):  
Sagar Suman Panda ◽  
Ravi Kumar B V V ◽  
D Patanaik

A simple, precise and accurate spectrophotometric method was developed for analysis of the osteoporesis drug alendronate sodium (ALS). The method is based on reaction of the drug with sodium-1,2-naphthoquinone-4-sulphonate (NQS) in presence of alkali to form a brown colored complex giving absorption maximum at 525 nm. The drug obeyed Beer’s law in the range of 5-70 µg/ml with a correlation coefficient of 0.999. The LOD and LOQ values are 1.7 µg/ml and 5.0 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 99.37%-100.46%. The R.S.D. values for intraday and inter-day precision were found to be 0.48 and 0.62, respectively. The optimized assay conditions were applied successfully for determination of ALS in pharmaceutical dosage forms. No interference was observed from the excipients present in the dosage form. The method is statistically validated as per the ICH requirements.  


Author(s):  
Bibhu Prasad Panda ◽  
N.S Dey ◽  
M.E.B. Rao

Over the past few decades, there has been an increased interest for innovative drug delivery systems to improve safety, efficacy and patient compliance, thereby increasing the product patent life cycle. The discovery and development of new chemical entities is not only an expensive but also time consuming affair. Hence the pharmaceutical industries are focusing on the design and development of innovative drug delivery systems for existing drugs. One such delivery system is the fast disintegrating oral film, which has gained popularity among pediatric and geriatric patients. This fast disintegrating film with many potential benefits of a fast disintegrating tablet but devoid of friability and risk of choking is more acceptable to pediatric and geriatric patients. Formulation of fast disintegrating film can be achieved by various techniques, but common methods of preparation include spraying and casting. These film forming techniques use hydrophilic film former in combination with suitable excipients, which allow the film to disintegrate or dissolve quickly in the mouth within a few seconds without the administration of water. In view of the advantages of the fast disintegrating films over the fast disintegrating tablets and other dosage forms, it has the potential for commercial exploitation. The oral film dosage form not only has certain advantages of other fast disintegrating systems but also satisfies the unmet needs of the market. The present review emphasizes on the potential benefits, design and development of robust, stable, and innovative orally fast- disintegrating films and their future scenarios on a global market as a pharmaceutical dosage form.  


2019 ◽  
Vol 24 (42) ◽  
pp. 4991-5008 ◽  
Author(s):  
Mohammed S. Algahtani ◽  
Abdul Aleem Mohammed ◽  
Javed Ahmad

Three-dimensional printing (3DP) has a significant impact on organ transplant, cosmetic surgery, surgical planning, prosthetics and other medical fields. Recently, 3 DP attracted the attention as a promising method for the production of small-scale drug production. The knowledge expansion about the population differences in metabolism and genetics grows the need for personalised medicine substantially. In personalised medicine, the patient receives a tailored dose and the release profile is based on his pharmacokinetics data. 3 DP is expected to be one of the leading solutions for the personalisation of the drug dispensing. This technology can fabricate a drug-device with complicated geometries and fillings to obtain the needed drug release profile. The extrusionbased 3 DP is the most explored method for investigating the feasibility of the technology to produce a novel dosage form with properties that are difficult to achieve using the conventional industrial methods. Extrusionbased 3 DP is divided into two techniques, the semi-solid extrusion (SSE) and the fused deposition modeling (FDM). This review aims to explain the extrusion principles behind the two techniques and discuss their capabilities to fabricate novel dosage forms. The advantages and limitations observed through the application of SSE and FDM for fabrication of drug dosage forms were discussed in this review. Further exploration and development are required to implement this technology in the healthcare frontline for more effective and personalised treatment.


2020 ◽  
Vol 16 ◽  
Author(s):  
Cansel Kose Ozkan ◽  
Ozgur Esim ◽  
Ayhan Savaser ◽  
Yalcin Ozkan

: The content and the application of pharmaceutical dosage forms must meet several basic requirements to ensure and maintain efficiency, safety and quality. A large number of active substances have limited ability to direct administration. Excipients are generally used to overcome the limitation of direct administration of these active substances. However, the function, behavior and composition of the excipients need to be well known in the design, development and production of pharmaceutical dosage forms. In this review, excipients used to assist in any pharmaceutical dosage form production processes of drugs, to preserve, promote or increase stability, bioavailability and patient compliance, to assist in product identification / separation, or to enhance overall safety and effectiveness of the drug delivery system during storage or use are explained. Moreover, the use of these excipients in drug delivery systems are identified. Excipient toxicity, which is an issue discussed in the light of current studies, also discussed in this review.


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