This white paper aims to provide a comprehensive
overview of the CMC guidance by the U.S. Food and Drug
Administration and present a streamlined approach for
development and manufacture of nasal spray products
Hydroxy propyl methyl cellulose (HPMC) is odorless, tasteless,non-toxic cellulose ethers produce from natural high molecula and protective colloid properties of surface activity and maintain moisture function properties ect.
Residual solvents
USP <467>
ICH Q3C
Classification of Residual Solvents by Risk Assessment
Options for Determining Levels of Class 2 Residual Solvents
Methods For Establishing Exposure Limits
Analytical Procedures
This white paper aims to provide a comprehensive
overview of the CMC guidance by the U.S. Food and Drug
Administration and present a streamlined approach for
development and manufacture of nasal spray products
Hydroxy propyl methyl cellulose (HPMC) is odorless, tasteless,non-toxic cellulose ethers produce from natural high molecula and protective colloid properties of surface activity and maintain moisture function properties ect.
Residual solvents
USP <467>
ICH Q3C
Classification of Residual Solvents by Risk Assessment
Options for Determining Levels of Class 2 Residual Solvents
Methods For Establishing Exposure Limits
Analytical Procedures
Solvents, not grouped in Class-1, Class-2 and Class-3, are often required to attain desirable properties of drug substances, products and excipients. Their use is particularly important in drug substances where a specific polymorph determines the bioavailability of drug product. How the limit of of such solvents is determined in pharmaceuticals, is the topic and content of this video. Further what other strategies are made available to regulatory personnel to justify such solvents' limits in pharmaceuticals.
Suspension, interfacial properties of suspended particles, settling in suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions, preservation of emulsions, rheological properties of emulsions.
1.Eudragit is the brand name for a diverse range of polymethacrylate-based copolymers. It includes anionic, cationic, and neutral copolymers based on methacrylic acid and methacrylic/acrylic esters or their derivatives.
2.Applications of different grades of Eudragit in colon-specific/enteric-coated/sustained release drug delivery and taste masking.
3.Eudragits are non-biodegradable, non-absorbable, and nontoxic.
4.Anionic Eudragit L dissolves at pH > 6 and is used for enteric coating, while Eudragit S, soluble at pH > 7 is used for colon targeting. Eudragit RL and RS, having quaternary ammonium groups, are water insoluble, but swellable/permeable polymers which are suitable for the sustained release film coating applications. Cationic Eudragit E, insoluble at pH less than 5, can prevent drug release in saliva and finds application in taste masking.
5.Eudragit is the brand name for a diverse range of copolymers based on polymethacrylates principally marketed by Evonik Industries, Germany. Eudragit was first introduced by Rohm & Hass GmbH, Darmstadt in 1953 as an alkaline soluble drug coating material resistant to stomach acid. It is used for functional pharmaceutical coatings, matrix formers in common granulation techniques as well as in direct compression.
5. Eudragit Nomenclature, Eudragit Abbreviation, Eudragit E, L, S, RL, RS, Cellulose acetate phthalate, HPMC phthalate, HPMC acetate succinate, PVAP
FLUID BED PROCESSOR IS USED FOR MAKING GRANULES FROM POWDER IT IS ALSO USED FOR BOTTOM SPRAY FOR COATING OF PELLETS. LAB MODEL AND PRODUCTION MODEL ALSO AVAILABLE
Solvents, not grouped in Class-1, Class-2 and Class-3, are often required to attain desirable properties of drug substances, products and excipients. Their use is particularly important in drug substances where a specific polymorph determines the bioavailability of drug product. How the limit of of such solvents is determined in pharmaceuticals, is the topic and content of this video. Further what other strategies are made available to regulatory personnel to justify such solvents' limits in pharmaceuticals.
Suspension, interfacial properties of suspended particles, settling in suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions, preservation of emulsions, rheological properties of emulsions.
1.Eudragit is the brand name for a diverse range of polymethacrylate-based copolymers. It includes anionic, cationic, and neutral copolymers based on methacrylic acid and methacrylic/acrylic esters or their derivatives.
2.Applications of different grades of Eudragit in colon-specific/enteric-coated/sustained release drug delivery and taste masking.
3.Eudragits are non-biodegradable, non-absorbable, and nontoxic.
4.Anionic Eudragit L dissolves at pH > 6 and is used for enteric coating, while Eudragit S, soluble at pH > 7 is used for colon targeting. Eudragit RL and RS, having quaternary ammonium groups, are water insoluble, but swellable/permeable polymers which are suitable for the sustained release film coating applications. Cationic Eudragit E, insoluble at pH less than 5, can prevent drug release in saliva and finds application in taste masking.
5.Eudragit is the brand name for a diverse range of copolymers based on polymethacrylates principally marketed by Evonik Industries, Germany. Eudragit was first introduced by Rohm & Hass GmbH, Darmstadt in 1953 as an alkaline soluble drug coating material resistant to stomach acid. It is used for functional pharmaceutical coatings, matrix formers in common granulation techniques as well as in direct compression.
5. Eudragit Nomenclature, Eudragit Abbreviation, Eudragit E, L, S, RL, RS, Cellulose acetate phthalate, HPMC phthalate, HPMC acetate succinate, PVAP
FLUID BED PROCESSOR IS USED FOR MAKING GRANULES FROM POWDER IT IS ALSO USED FOR BOTTOM SPRAY FOR COATING OF PELLETS. LAB MODEL AND PRODUCTION MODEL ALSO AVAILABLE
Tadalafil under the name of Cialis is used to treat erectile dysfunction impotence and symptoms of benign prostatic hypertrophy enlarged prostate.
Now Varies Type of packing Tadalafil.
Manufacturer by Shreevenkatesh international limited. from india.
Caleva Process Solutions
http://www.caleva.com
Another resourceful Powerpoint Presentation from Caleva Process Solutions. These selection of slides will provide you with some very useful information on Extrusion Spheronization. This includes general information, the process of Extrusion Spheronization, Wet Massing and Pelletization!
For more information on Extrusion Spheronization, visit:
http://caleva.com/
The word “Pellet” has been used to describe a variety of systematically produced, geometrically defined agglomerates obtained from diverse starting materials utilizing different processing conditions. Pellets range in size, typically, between 0.5 – 1.5 mm, though other sizes could be prepared. Pellets are for pharmaceutical purposes and are produced primarily for the purpose of oral controlled-release dosage forms having gastro resistant or sustained-release properties or the capability of site-specific drug delivery.
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How to Start Pharmaceutical Pellets & Granules Processing Industry in India, most Profitable Pharmaceutical Pellets & Granules Processing Business Ideas, Small Scale Pharmaceutical Pellets & Granules manufacturing Projects, How to Start a Pharmaceutical Pellets & Granules Production Business, Pharmaceutical Pellets & Granules Production Based Small Scale Industries Projects, New small scale ideas in Pharmaceutical Pellets & Granules Production industry, Detailed Project Report on Pharmaceutical Pellets & Granules Production industry, Pre Feasibility report on Pharmaceutical Pellets & Granules manufacturing industry, Technical Material Market Report on Pharmaceutical Pellets & Granules Production business, Pharmaceutical Pellets & Granules Production Market - Industry Trends, Prices, Manufacturing, Pre-Investment Feasibility Study on Pharmaceutical Pellets & Granules Production industry, Techno-Economic feasibility study on Pharmaceutical Pellets & Granules manufacturing industry, Feasibility report on Pharmaceutical Pellets & Granules manufacturing industry, Free Project Profile on Pharmaceutical Pellets & Granules manufacturing business, Industrial Project Report, Project consultant, Project consultancy, NPCS, Niir, Process technology books, Business consultancy, Business consultant, Project identification and selection, Preparation of Project Profiles, Startup Project for Pharmaceutical Pellets & Granules processing business, Business Plan for a Startup Business, Start-up Business Plan for Pharmaceutical Pellets & Granules processing business, Start Up India, Stand Up India, Pharmaceutical Pellets & Granules Making Small Business Manufacturing, small scale Pharmaceutical Pellets & Granules making machine and Pharmaceutical Pellets & Granules production line, Pharmaceutical Pellets & Granules making machine factory, modern small and cottage scale industries, How to Start a Pharmaceutical Pellets & Granules processing industry?
Evaluation of tablets Useful for the Pharmacy Student ... It -contains all the information on how to evaluate the Tablet as per Indian Pharmacopoeia.
Evaluation consist the Procedure of Dissolution.Disintegration,
Formulation and Evaluation of Unidirection Bucco- Adhesive Tablet of Sumatrip...Ajay Champaneri
The objective of this research work was to formulate and evaluate PEO WSR
301 bucco-adhesive tablet in combination with Carbopol 934p for controlled
release of Sumatriptan Succinate. To bypass high hepatic first pass metabolism,
unidirection bucco-adhesive tablet is selected dosage form for the experimental
work. Initially preliminary trials were carried out for the selection of excipients
and their relative quantity for incorporation in the dosage form. From the results,
Polyethylene oxide-PEO WSR 301 (mucoadhesive polymer) and Carbopol 934p
(control release) were selected as a suitable excipients for experimentation.
Composition of the mucoadhesive tablet was optimized using 32 full factorial
design where amount of PEO WSR 301 (X1) and amount of Carbopol 934p (X2)
were taken as independent variables and mucoadhesive strength, Drug release
at 6 hour and % swelling index taken as response variables. The formulations of
design batches were characterized for post compression parameters like weight
variation, hardness, thickness, friability, Drug content, swelling index, ex-vivo
Mucoadhesive strength, and surface pH, drug release at 6 hr., ex-vivo residence
time, and curve fitting analysis. The optimized formulation was obtained using
Minitab software based on desirability value. Characterization of optimized
batch was carried out by, ex-vivo permeation study.
We provide You with the best biotechnology products and services that ensure high quality and innovation.
Founded in 1992 and ISO 9001:2015 certified, BioTeZ supports the research in many areas, both on the Biotechnology Campus Berlin-Buch, Germany, as well as in facilities around the world. For 25 years, we are continuously motivated for new challenges to meet Your needs.
Since 2019 Steffens-Biotec, Ebringen, ISO 13485 certified is a sister company of BioTeZ specialized in manufacturing CE in-vitro diagnostics.
We are specialized in immunochemistry and the development and production of high-quality components for ELISA, Immuno Assays & Protease Activity Kits, Immuno Affinity Chromatography and Lateral Flow Tests.
ABSTRACT
Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence
of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are
continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures
and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of
OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation
and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was
launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements.
Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two
dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the
treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized
trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open
label 40 week continuation study.
KEYWORDS
Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.
Preparation and evaluation of deferasirox effervescent release tabletsSriramNagarajan19
Deferasirox is an oral iron chelater used to reduce chronic iron over load in patients who are receiving long term blood transfusion for condition such as beta-thalassemia. In this study deferasirox drug were formulated by direct compression. Six formulations of effervescent tablets were prepared by using different concentrations of effervescent agents to get desired release profile of reference product. Drug - Exciepient compatibility was studied by FT-IR spectral analysis. Effervescent tablets of deferasirox drug were prepared by using various excipients .Pre compressive parameters like carr’s index of all formulations between 22.54 ± 0.1 to 11.68 ±0.19, indicates passable compressibility index. Angle of repose of formulations from 37.34±0.04 to 33.50 ±0.14 i.e.., it declares that all are possessing good flow properties and hausners ratio of all formulations was 1.29±0.09 to 1.12±0.10 which satisfies the limits of compressibility. Post compressive parameters like weight are within limits .Hardness test of all the formulations from 9.3± 0.13 to 10.3 ±0.45 kg/cm2 .All the evaluation parameters were under acceptable ranges. The in vitro drug dissolution studies were carried out for the formulations in pH6.8 phosphate buffer .Dissolution profiles of all trials were done among all the formulations F6 better release. Stability studies were carried out for optimized formulation as per ICH guidelines.
Design and in vitro evaluation of bilayer tablets of Tramadol hydrochloride f...ijperSS
ABSTRACT
The aim of the present work was to design bilayer tablet of Tramadol hydrochloride for biphasic release and its in vitro evaluation. Bilayer tablets comprises of two layers, i.e., immediate release and sustained release layer. The immediate release layer comprised of various superdisintegrants and the sustained release layer comprised HPMC K4M, HPMC K15M, and HPMC K100M as the release retarding polymers. The bilayer tablets were prepared by direct compression method. The seven different formulations (F1-F7) were evaluated for pre- and post-compression parameters. In vitro dissolution studies were carried out for the optimized formulation (F6). It has found that the release of drug from the sustained release layer by 99.5% in 12 h. FT-IR studies revealed that there was no interaction between the drug and polymers used in the study. The release of Tramadol hydrochloride was found to follow a pattern of Korsmeyer-Peppas, with Quasi-Fickian diffusion. Accelerated stability studies were carried out on the prepared tablets in accordance with ICH guidelines. There were no changes observed in physicochemical properties and drug release pattern of tablets. Biphasic drug release pattern was successfully achieved through the formulation of bilayer tablets in this study.
Key words: Tramadol hydrochloride, bilayer tablet, direct compression, carmellose sodium, cross povidone, HPMC K4M.
Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfthesiliconleaders
In the recent edition, The 10 Most Influential Leaders Guiding Corporate Evolution, 2024, The Silicon Leaders magazine gladly features Dejan Štancer, President of the Global Chamber of Business Leaders (GCBL), along with other leaders.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
In the Adani-Hindenburg case, what is SEBI investigating.pptxAdani case
Adani SEBI investigation revealed that the latter had sought information from five foreign jurisdictions concerning the holdings of the firm’s foreign portfolio investors (FPIs) in relation to the alleged violations of the MPS Regulations. Nevertheless, the economic interest of the twelve FPIs based in tax haven jurisdictions still needs to be determined. The Adani Group firms classed these FPIs as public shareholders. According to Hindenburg, FPIs were used to get around regulatory standards.
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
At Techbox Square, in Singapore, we're not just creative web designers and developers, we're the driving force behind your brand identity. Contact us today.
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesHolger Mueller
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
2. COMPANY PROFILE
Murli Krishna Pharma is an EU-GMP/ WHO-GMP and PIC/S approved
plant.
We manufacture pre finished formulation intermediates that can be
directly employed into formulating solid dosage forms, can be blended
with suspension base for use in suspensions. We also have developed
nano particles for direct use in ophthalmic solutions and injectables
We are one among the global top 10 NDDS manufacturers and one of the
five regulatory compliant and regulatory approved manufacturers of pre
finished formulation intermediates.
We provide a complete patient friendly solution to the generic
manufacturers of the World.
MURLI KRISHNA PHARMA
3. The facility of Murli Krishna Pharma
Pvt. Ltd. for manufacturing of coated
pellets, is situated
at Plot. No. D-98 MIDC, Ranjangaon.
The facility is certified by Food and
Drug administration Maharashtra State.
Factory Registration and License No.:
PD - 162 and PD - 115
Images of Extruders & Spheronizers in our
R &D
4. Mesh Size Dose Fill Wt. Capsule Size Capsules per kg
of pellets
14 # 20 / 18 # 30 120 mg 240 mg 1 4166
14 # 20 / 18 # 30 60 mg 120 mg 3 8333
18 # 30 120 mg 240 mg 2 4166
18 # 30 60 mg 120 mg 4 8333
Number of Capsules per kg of MKPPL Pellets
Pellets offer a more uniform surface and also have a particle size
distribution in a narrow window compared to granules. This ensures
a better dose uniformity and also a more uniform transfer of dose.
5. Description:
Anti-Obesity drug
Reversible inhibitor of lipases.
Used for losing weight
Patent Holders
Roche- Switzerland
Our Non-Infringement
Patent non-infringing process
Comparative Dissolution Data
Time
(Min)
Dissolution (%)
Of MKPPL
B.No. PDL/ORE-010609
Dissolution (%) of
XENICAL B.No. M1425U
0 0 0
10
71.5 76.0
20
83.4 88.1
30
90.1 93.5
45
92.6 96.9
6. 5. Dissolution Profile:
Differential Factor (F1) was found to be 4.25 (0-15 is acceptable)
Similarity Factor (F2) was found to be 69.48 (50-100 is acceptable)
Conclusion: From the above values of F1 and F2, it can be concluded that Orlistat pellets
manufactured at Murli Krishna Pharma compare favorably with that of the Innovator
product.
7.
8. Variations of the Product:
Percentage: 50%
Mesh Size: 14 # 20, 18 # 30
Documentation Availble:
DMF in CTD format is available
Stability Data- Accelerated and Long term stability is available.
Registrations :
Our product was registered in Iran, Mexico, Columbia, Switzerland, Europe, Egypt, Romania
Bangladesh, Pakistan, Turkey, etc…
9. Mesh Size Dose Fill Wt. Capsule Size Capsules per kg
of pellets
14 # 20 / 18 # 30 120 mg 240 mg 1 4166
14 # 20 / 18 # 30 60 mg 120 mg 3 8333
18 # 30 120 mg 240 mg 2 4166
18 # 30 60 mg 120 mg 4 8333
Number of Capsules per kg of MKPPL Pellets
Pellets offer a more uniform surface and also have a particle size
distribution in a narrow window compared to granules. This ensures
a better dose uniformity and also a more uniform transfer of dose.
