Shruti Bhat PhD (Pharmaceutics), MBA, Lean Six Sigma Black Belt
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Lean Innovation, Hoshin Kanrii and Six Sigma (as DFSS) for Product Design, Development and Manufacture via 3D Printing; a Case Study

2/1/2019

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Lean Innovation, Hoshin Kanrii and Six Sigma (DFSS- design for six sigma) for product design, development and manufacture via 3D Printing (i.e. Additive Manufacturing) Case Study by Dr. Shruti Bhat, gives benefits of applying Hoshin Kanrii, DFSS and Lean Innovation techniques to a drug product design, development and manufacture via 3D Printing.

The study findings however can be extended to product development across other industry verticals.

Some of the benefits of applying continuous improvement methodologies such as Lean, Hoshin Kanrii and Six Sigma to research and product development include-
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  1. Application of Hoshin Kanrii and DFSS along with Quality-by-Design (QbD) to product development usually brings novelty in product features, process characteristics and/or product utility, thus favors patenting and generation of additional revenues.
  2. While, Lean Innovation creates products with effective and efficient production and packaging processes, with no scope for ‘rework’ thus, better Operations Management.

​The study uses Isosorbide dinitrate (ISDN) as model drug, although other drugs can also be used in this therapeutic platform.

2x3 Factorial Design of Experimentation (DOE) was used to design drug beads. The results were evaluated for regression analysis, Main and interaction effects of parameters, Contrast Column Dispersion effects, Normal Probability Plots, Pareto and Process Capability Analysis.

The drug beads were further used as ‘starter’ seeds to develop MUPS (multi-unit particulate system) anti-angina ‘rate-programmed’ drug product.

The pharmacokinetic- pharmacodynamic (PK-PD) modeling was done using Doebrinska- Welling equation. MUPS were developed using 3D Printing technology via a 12- Run Plackett Burman DOE.

All hardware, software applications involved in the study were pre-validated. All qualifications i.e. Design Qualification (DQ), Installation Qualification (IQ),  Operational Qualification (OQ), Performance Qualification (PQ) for each experimental run was done as per USFDA guidelines. Data was analysed statistically using Paired ‘t’ test. Reliability Testing was conducted as per ICH current Good Clinical Practices (cGCP) guidelines.

Product prototype and Reference listed drug (RLD) were compared for bioequivalence compliance. The prototype is ready for commercialization.

This study also gives benefits of using 3D Printing technique for pharmaceuticals and how the technique can be applied to product development across other industry verticals!
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For details on how to apply Lean Innovation, Hoshin Kanrii and DFSS to product design, development and manufacture, watch the video …

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To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

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Recommended reading:​

  1. Workshops & Online Courses for Pharmaceutical Research and Drug Product Development by Dr. Shruti Bhat
  2. Kaizen for Cost-Savings and Organizational Excellence
  3. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
  4. How to develop a culture of ‘Continuous Improvement’ in an organization?
  5. ​Innovation is not an initiative. It’s a business process !​
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Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?

11/3/2018

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impurities in medicinal products, irbesartan, valsartan imurities, shruti bhat, valsartan recall, irbesartan recall, formulation expert, continuous improvement for pharmaceuticals

First Valsartan, now Irbesartan formulations are going thru a recall. As these product recalls are happening world-over, the chaos is enormous...

For the affected patients, it is horrifying to learn that they have unsuspectingly consumed a medicine that contains a potential carcinogen. In addition they have now to deal with product shortages; a product they consume daily to keep their blood pressure in check!

For pharma companies, this is a huge hit to their brand image as well as to their bottom-line. 

Even though Impurities in drugs and drug products are a part of manufacturing process, drug companies strive hard to keep them at minimal and within specifications; be it as per ICH, FDA or company's internal standards. So what happened in case of Valsartan, Irbesartan? Are compendial testing procedures adequate? How were these impurities missed?

Several such questions arise... A root cause analysis will dig into reasons for the lapse, but prevention is better than cure … this is more so true for defective pharmaceutical products. Lesson learnt from *SARTAN mishaps is as a wakeup call !

Recalls will surely stop patients from taking defective batches of Valsartan, Irbesartan. But what about the damage already done to patients who have consumed these defective products? And what is it that we must do to prevent something similar from happening again; not only for *SARTANs but any other drug or drug product?
​

Impurities in drug/drug products: How NOT to miss them?

Pharma R&Ds follow rigorous procedures to keep impurities/ degradation products at minimal possible levels. Drugs and drug products are developed using high standards and elaborate regulated procedures, yet how were these impurities missed out? And what to do to NOT miss them?
​
A thumb rule whenever a 'defect' occurs means, underlying 'processes' are faulty and must be revisited- improved or re-designed. 

Here's the starting point-

Drug and drug products are developed using ICH Quality norms, QbD (Quality-by-Design), PAT (Process Analytical Techniques) and similar such sophisticated guidances which facilitate 'risk-assessment'. Based on *SARTAN scenario, a logical question that pops up is- Are these 'risk- assessment' tools good enough? Or is there an application failure? In the former case, guidance documents need overhaul, while the later, points to inadequate training (around appropriate implementation of these guidances).
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Secondly, the whole concept of 'Mistake-Proofing' pharmaceutical products must be revisited ...

​Impurities are consequence of drug/ drug product manufacturing process. Any potential carcinogenic impurity carry overs into medicinal products and patients is no doubt hazardous; but it doesn't end there. What about these carcinogenic impurities getting into effluent systems and perhaps into the environment? This puts a larger population at risk!

Existing IPQC, QA monitoring norms are not good enough when we deal with complex small molecule drug candidates. All processes (technical and/or operational) leading to the products must be studied comprehensively,  supervised, modified and improved 'Continuously' ...
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A comprehensive Continuous Improvement methodology such as Kaizen must be rooted into pharmaceutical company operations 

Thirdly, stronger risk-assessment and risk-control tools must be adopted during development and processing of pharmaceutical products. Additionally, multiple risk-assessment and risk-control tools must be employed as standard operating procedure.

​Besides CAPA, FMEA, QbD, ICH and compendial norms, a structured 'Mistake-Proofing' methodology such as Poka Yoke- a Japanese concept for 'Mistake-Proofing', must be adopted as an integral part of Drug Discovery and Drug Product Development programs.
​​
Poka Yoke based Mistake-Proofing must be customized by companies for their line of business and product mix.

Practising such 'Mistake-Proofing-by-Design' principle will imbue pharmaceutical products with quality to face any rainy day. It main rain tomorrow!
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​

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About the Author Shruti Bhat PhD, MBA, Certified Lean Six Sigma Black Belt 
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker.

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn 

#Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #Losartan #Valsartan #Irbesartan #USFDA   #Quality  #eLearning  #ManufacturingManagement #Pharmaceutical  #LifeSciences   #LeanManagement  #KaizenLeaderMasterclass    #RiskManagement  #Impurities

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Workshops & Online Courses for Pharmaceutical Research and Drug Product Development by Dr. Shruti Bhat

10/23/2018

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About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn 

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USFDA Unveils Two Draft Guidance Documents to Facilitate Generic Development of Transdermal and Topical Dosage Forms

10/9/2018

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revised fda guidelines for transdermal patch and topical products
revised usfda guidelines for transdermal and topical products
The United States Food and Drug Administration (USFDA) today 9th October 2018, unveiled one revised draft guidance and another new draft guidance to help advance the development of generic Transdermal/Topical Delivery Systems (TDS). Here's a snapshot:

When applied to a patient’s skin, Transdermal/ Topical products are expected to deliver the correct dose of the medication consistently and for the expected length of time, while adhering consistently and uniformly to the skin, even when the skin is exposed to water, humid environment and/or body movement.

Because of the inherent complexity of delivering a drug through a transdermal/ topical system, making generic copies of these branded (reference listed) transdermal/ topical drug products is hard; and the two draft guidance documents aim to mitigate this problem.

ANDA Guidance document for assessing Irritation and Sensitization:

This 12-page guidance provides recommendations for Abbreviated New Drug Application (ANDA) sponsors on the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system.

Applicants must perform a comparative assessment of the generic and reference listed transdermal/topical drug products using an appropriately designed skin I/S study with human subjects. The draft document demonstrates that the potential for a skin irritation or sensitization reaction with the Test-TDS is no worse than the reaction observed with the Reference-TDS.

Study design and conduct, considerations for statistical analysis, overall assessment of adverse event data and format of data submissions are outlined in the draft guidance. (Note: The recommendations relating to the design and conduct of I/S studies described in this guidance replace the recommendations related to I/S studies provided in product-specific guidances published before this guidance. This set the stage for revisions in bioequivalence (BE) study guidelines for 23 TDS products).

ANDA Guidance document for Assessing Adhesion

This revised 9-page draft guidance supersedes a draft from June 2016 and provides recommendations for the design and conduct of studies evaluating the adhesive performance of a TDS.

Apropos the guidance document, depending on the objective(s) of a transdermal/ topical dosage form product development program, applicants may choose to evaluate transdermal /topical adhesion in clinical studies performed to evaluate adhesion only or in clinical studies performed with a combined purpose (example- for simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints).

Additional topics covered in the revised draft include the study design and conduct, considerations for statistical analysis, as well as recommendations on the combined evaluation of adhesion and bioequivalence.
About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn 

#ShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #Innoworks  #Innovation  #Quality  #eLearning  #Business  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeScience  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #ShiftingParadigms #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  #Kanban  #FMEA  #RiskManagement

References:
  1. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry
  2. Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry


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Lean Manufacturing in Food, Drug, Cosmetics & Chemical Industry

10/9/2018

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Learn about how to use LEAN Business Process Improvement methodology for Innovation and Manufacturing …

Case Study: Improved productivity of pellet manufacturing by 28% per shift via LEAN

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Popular Books on Business Process Improvement:
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How to choose business process improvement methodology for your organization and measure the positive change, up to speed with workflow, business process management and continuous improvement executive guide series book, shruti bhat
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To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

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Advances in pharmaceutical research- use of nanotechnology as therapeutic platforms for disease management.

8/15/2017

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Dr. Shruti Bhat, Pharmaceutical Industry Thought Leader, brings to you some highlights from current pharma and clinical research news, views and data.
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Picture
New nanoparticles deliver bigger drug payload.
Scientists at Brigham and Women's Hospital and the Harvard-MIT Division of Health Sciences and Technology have developed new nanoparticles from a modified polymer that can more efficiently load up on cancer drugs and deliver them more precisely.

These new nanoparticles inhibit the MARK signaling pathway, which helps prevent the spread of cancer cells and makes tumors more susceptible to chemotherapy.

"Current chemotherapy drugs must be administered in high concentration throughout the body in order to destroy tumor cells, translating to high toxicity and discomfort for the patient, mainly due to the effects on normal cells," co-lead author Rania Harfouche said in a release. By modifying the polymer, researchers "allow for lower drug concentrations to be used, and provide opportunity for more potent treatments with lesser side-effects for the patient."

In a study involving mice, the nanoparticles inhibited tumor growth. And the scientists say that this new approach to cancer therapy could have wide applicability. ​
​

​Scientist creates 'nanocage' drug delivery system.
​Washington University's Younan Xia has been attracting considerable attention for his research work on microcapsules that can precisely deliver a drug payload right where it's needed.
shrti bhat, kaizen for pharmaceuticals and medical devices industry
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​Xia has been making microscopic gold 'nanocages,' tiny particles encased in polymer strands that collapse when exposed to heat. "But the really cool part," says Xia, "and the cool part of nanotechnology generally, is that the tiny gold cages have very different properties than bulk gold." In particular, they respond differently to light.

Using a near infrared light, the scientist can trigger a collapse at any point, leaving the tissue unharmed. Adjusting the light can recalibrate the release rate. And by designing the polymers to latch onto specific disease targets, such as a tumor, Xia believes he can concentrate the drug right where it's needed. ​
​

​Nanoparticles used to deliver targeted ED drugs.
​Nanoparticles "smaller than a grain of pollen" have been engineered to carry minute quantities of therapeutics for erectile dysfunction, effectively delivering the drug directly through the skin in animal models. And the team of researchers at Albert Einstein College of Medicine at Yeshiva 
 University says that the same approach could be a better alternative to existing drugs while safely working in men who currently are prohibited from taking the tablet meds.
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​Scientists used rats bred to suffer from erectile dysfunction to test the nanoparticles. "The response time to the nanoparticles was very short, just a few minutes, which is basically what people want in an erectile dysfunction medication," says Dr. Kelvin Davies. "In both rats and humans, it can take 30 minutes to one hour for oral erectile dysfunction medications to take effect."

The oral drugs are associated with a number of side effects, including blurred vision and upset stomachs. Men who have suffered a heart attack, meanwhile, are prevented from getting the ED drugs at all. But the researchers say that a locally applied topical solution was effective without side effects in rodents. ED drugs have been prominent best-sellers and an improved approach could also prove to be highly profitable.
​

​Nanoparticles boost antibacterial treatments.
The University of Liverpool and IOTA NanoSolutions have developed man-made nanoparticles that could increase the effectiveness of antibacterial treatments. Many current drugs are insoluble and need to be administered at higher doses in order to work. However, this increases the chances that bacteria and other organisms will build up a resistance to the drugs. In time, new formulations of medicines must be developed in order to knock out the mutated organisms.
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Available as Paperback and Digital Editions
University of Liverpool researchers found that in some instances, the nanoparticles can be used to make insoluble drugs behave like soluble drugs, increasing their effectiveness at lower doses. Scientists are concentrating on applying the nanoparticle technology to antiparasitic drugs that treat malaria.

"Already our technology has shown the potential to improve a range of current medicines and may lead to treatments that prevent drug resistance," said Professor Steve Rannard, from the Department of Chemistry, who is also co-founder and current Chief Scientific Officer of IOTA NanoSolutions. "If our approach can deliver new antimalarial treatments, it may help to prevent millions of deaths per year and improve the lives of hundreds of millions of current malaria sufferers."
Nanoparticles research aids drug development.
Drugs with the ability to dissolve have much stronger efficacy, however many drugs are insoluble. In order to compensate, drugs often need to be administered in higher doses. This increases the possibility of bacteria and other organisms mutating as the high doses make it easier for them to build resistance to the drugs. This leads to treatments becoming obsolete and the need for new medicines to be developed.

Chemists at the University of Liverpool working with IOTA NanoSolutions have now developed a new technology to produce nanoparticles of insoluble drugs that mimic the behaviour and the effectiveness of dissolved drugs.

Nanoparticles are man-made particles manufactured for use in a number of industries including the cosmetic and pharmaceutical industry; they can make materials stronger, lighter and cleaner.
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​Recent data has shown that in some cases, low concentrations of insoluble drugs in a nanoparticle form can be more active than previously thought, offering the potential to administer drugs in low dosages without reducing the effectiveness of the treatment. The new technology is allowing the scientists to develop new medicines by converting currently available drugs into a nanoparticle form. Antiparastitic drugs to treat malaria are also being developed in collaboration with the Liverpool School of Tropical Medicine.

Professor Steve Rannard, from the Department of Chemistry who is also co-founder and current Chief Scientific Officer of IOTA NanoSolutions, said: "Already our technology has shown the potential to improve a range of current medicines and may lead to treatments that prevent drug resistance. If our approach can deliver new antimalarial treatments, it may help to prevent millions of deaths per year and improve the lives of hundreds of millions of current malaria sufferers."

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Nanoparticle program delivers anti-cancer therapy.
A research team at Washington University in St. Louis has combined a nanoparticle platform used in imaging growing blood vessels and combined it with the fungal drug fumagillin to create a new weapon to fight the growth of tumors. Fumagillin has long been known as a potent anti-cancer therapy, but its neurotoxic side effects are too harsh for patients. To circumvent the side effects, the scientists adapted nanoparticles designed to dock on a protein carpeted on endothelial cells clustered on the walls of new blood vessels and loaded them with fumagillin. By targeting the therapy directly at the new blood vessels, the therapy can stop angiogenesis, a key target in oncology research.

"It basically becomes a vehicle to dump off a truckload of cargo," Joseph DeSimone of the University of North Carolina tells MIT Technology Review. "It's sort of like a Trojan horse."

There are a number of research programs underway relying on animal studies to determine the effect of new nanoparticle technologies that can interrupt angiogenesis. First-generation nanoparticle therapies rely on passive delivery methods while this second generation round of research is working on new technology aimed at more precise targeting of disease.


Nanomaterials used to fix neuron damage.
Northwestern University researcher Samuel Stupp has presented the results of a study in which he injected nanomaterials into the severed spinal cords of mice, allowing them to walk again after several weeks of therapy. The nanomaterials he used were designed to self-assemble into nanofibers which repaired damaged neurons. The research offers new insights into the near-term research potential of nanotechnology and offers hope for patients with Alzheimer's and Parkinson's who suffer from severe neuron damage.

"Regenerating bone and cartilage are our first targets," Stupp told the Chicago Tribune. "That would be very important to Baby Boomers who value their quality of life. We are also working with regenerating blood vessels to address damage from heart attacks. (Nanotechnology) will first aid in diagnosing illness, but it also will provide therapies to alleviate or cure." 
​

Nanoparticles offer ovarian cancer treatment approach.
Magnetic nanoparticles have been used to ‘drag' cancer cells out of the bodies of mice. Scientists at Georgia Tech coated the nanoparticles with a targeting molecule that caused them to bond to the cancer cells. And the researchers say the approach could be used to treat metastatic ovarian cancer. During metastasis, the cancer cells drift in the abdominal area, offering a target for the nanoparticles. They believe that a patient's abdominal fluid could be drained, cancer cells filtered out, and then infused back into the abdominal cavity.

"It's possible that the particles may not ever have to go into the patient's body," says John McDonald, the chief scientific officer of the Ovarian Cancer Institute at Georgia Tech. "That would be preferable, because then you don't have to worry about any potential toxicity."


About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
 
#ShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #Innoworks  #Innovation  #Quality  #eLearning  #Business  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeScience  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #ShiftingParadigms #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  #Kanban  #FMEA  #RiskManagement


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References-
Read more: http://www.fiercebiotechresearch.com/story/new-nanoparticles-deliver-bigger-drug-payload/2009-04-28#ixzz0kS4utcYO
http://www.sciencedaily.com/releases/2009/11/091101132539.htm
Read more: http://www.fiercebiotechresearch.com/story/nanoparticles-used-deliver-targeted-ed-drugs/2009-09-22#ixzz0kS5TN3ev
Read more: http://www.fiercebiotechresearch.com/story/nanoparticles-could-boost-antibacterial-treatments/2008-11-10#ixzz0kS5umDfi
Read more: http://www.fiercebiotechresearch.com/story/nanomaterials-used-to-fix-neuron-damage/2007-05-01#ixzz0kS6W39Pt
Read more: http://www.fiercebiotechresearch.com/story/nanoparticles-offer-new-approach-treating-ovarian-cancer/2008-07-22#ixzz0kS6iAbJA
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Pulmonary route for mucosal drug delivery- II

7/5/2017

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Picture

Dry powder inhalers-  

Dry powder inhalers (DPIs) are breath-actuated devices, by virtue of the fact that the kinetic energy imparted to the drug comes from the patient inhaling. The basic construction of all DPIs consists of mouthpiece and a turbulence chamber for dispersing the drug into the air stream. To reduce the incidence of agglomeration, the active material is normally loosely bound to a longer carrier such as lactose. A metered dose of the drug is introduced into the chamber from its storage area, which can be bulk, capsules or blister form. The patient then inhales and the resulting turbulence possibly assisted by mechanical agitation disperses the powder into the air stream and separates the drug from the carrier. Continued inhalation carries the drug into the airways where deposition occurs. Because of design constraints in order to achieve optimum dispersion, airflow rates through the device have to be relatively high = 60 L/min. Because of high air flows mean and high flow velocities, the inertia of the particles is higher and the resulting deposition in the upper airways in higher. 

Future developments-  

This area is probably best reviewed by considering the possible developments within each group. 

Intrapulmonary and Endotracheal Routes of Administration :

According to current guidelines recommended for the management of cardiac arrest, the American Heart Association has recommended that when intravenous or intraosseous routes cannot be established, endotracheal administration of some resuscitation drugs be used. Medications that can be absorbed through the trachea include lidocaine, epinephrine, atropine, naloxone, and vasopressin (American Heart Association [AHA], 2005). Although the optimal dose of these drugs has yet to be established, two to two and one half times the recommended intravenous dose is used (AHA, 2005).

Recent studies investigated the intrapulmonary route of drug administration. One study suggests that intrapulmonary vancomycin may have efficacy in acute lung injuries, such as meconium aspiration syndrome in neonates (Jeng, Lee, & Soong, 2007). Televancin is also being studied for intrapulmonary use. Because the antibacterial activity is not affected by pulmonary surfactant, further studies of intrapulmonary televancin for use in treating gram-positive respiratory infections are underway (Gotfried et al., 2008). 

Nebulisers, by virtue of their design and their need for an external energy source, tend in the main to be bulky and expensive and because of longer treatment period come low on social acceptability scale. Work in this area is likely to be directed towards smaller, most compact, low cost units suitable for home use. Metered dose inhalers represent a field in which developments are currently taking place. Continued interest is being shown in innovations on BAIs and spacer chamber based MDI. Dry powder inhalers will continue to appear in the market place in new and improved forms, the main areas of improvement being in the airflow/dispersion chambers and the drug storage systems, the main objective being ease of use. 
​

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