John Wahlich - Academia.edu (original) (raw)
Papers by John Wahlich
The Academy of Pharmaceutical Sciences (APSGB) is delighted to partner with the British Journal o... more The Academy of Pharmaceutical Sciences (APSGB) is delighted to partner with the British Journal of Pharmacy to publish key abstracts of posters presented at this year’s APS PharmSci Conference held at the University of Hertfordshire 5th to 7th September 2017. The Conference is the premier pharmaceutical sciences event in the UK focussing on ‘The Science of Medicines’ and covers all aspects related to the discovery, development, production and testing of drug products.
Pharmaceutics, 2021
Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuo... more Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.
Pharmaceutics, May 3, 2019
A special symposium of the Academy of Pharmaceutical Sciences Nanomedicines Focus Group reviewed ... more A special symposium of the Academy of Pharmaceutical Sciences Nanomedicines Focus Group reviewed the current status of the use of nanomedicines for the delivery of biologics drugs. This meeting was particularly timely with the recent approval of the first siRNA-containing product Onpattro™ (patisiran), which is formulated as a lipid nanoparticle for intravenous infusion, and the increasing interest in the use of nanomedicines for the oral delivery of biologics. The challenges in delivering such molecules were discussed with specific emphasis on the delivery both across and into cells. The latest developments in Molecular Envelope Technology ® (Nanomerics Ltd, London, UK), liposomal drug delivery (both from an academic and industrial perspective), opportunities offered by the endocytic pathway, delivery using genetically engineered viral vectors (PsiOxus Technologies Ltd, Abingdon, UK), Transint™ technology (Applied Molecular Transport Inc., South San Francisco, CA, USA), which has the potential to deliver a wide range of macromolecules, and AstraZeneca's initiatives in mRNA delivery were covered with a focus on their uses in difficult to treat diseases, including cancers. Preclinical data were presented for each of the technologies and where sufficiently advanced, plans for clinical studies as well as early clinical data. The meeting covered the work in progress in this exciting area and highlighted some key technologies to look out for in the future.
Pharmaceutics
A meeting organised by the Academy of Pharmaceutical Sciences focussed on the challenges of devel... more A meeting organised by the Academy of Pharmaceutical Sciences focussed on the challenges of developing medicines for older adults. International experts discussed the complexity introduced by polypharmacy and multiple morbidities and how the risk–benefit ratio of a medicine changes as an individual ages. The way in which regulatory authorities are encouraging the development of age-appropriate medicines was highlighted. Examples were provided of the difficulties faced by the older population with some medicinal products and suggestions given as to how the pharmaceutical scientist can build the requirements of the older population into their development of new medicines, as well as improvements to existing ones.
British Journal of Pharmacy
Drug Development and Industrial Pharmacy
Objective: V565 is a novel oral anti-tumor necrosis factor (TNF)-a domain antibody being develope... more Objective: V565 is a novel oral anti-tumor necrosis factor (TNF)-a domain antibody being developed for topical treatment of inflammatory bowel disease (IBD) patients. Protein engineering rendered the molecule resistant to intestinal proteases. Here we investigate the formulation of V565 required to provide gastro-protection and enable optimal delivery to the lower intestinal tract in monkeys. Methods: Enteric-coated V565 mini-tablets were prepared and dissolution characteristics tested in vitro. Oral dosing of monkeys with enteric-coated mini-tablets containing V565 and methylene blue dye enabled in vivo localization of mini-tablet dissolution. V565 distribution in luminal contents and feces was measured by enzyme-linked immunosorbent assay (ELISA). To mimic transit across the damaged intestinal epithelium seen in IBD patients an intravenous (i.v.) bolus of V565 was given to monkeys and pharmacokinetic parameters of V565 measured in serum and urine by ELISA. Results: Enteric-coated mini-tablets resisted dissolution in 0.1 M HCl, before dissolving in a sustained release fashion at neutral pH. In orally dosed monkeys methylene blue intestinal staining indicated the jejunum and ileum as sites for mini-tablet dissolution. Measurements of V565 in monkey feces confirmed V565 survival through the intestinal tract. Systemic exposure after oral dosing was very low consistent with limited V565 mucosal penetration in healthy monkeys. The rapid clearance of V565 after i.v. dosing was consistent with renal excretion as the primary route for elimination of any V565 reaching the circulation. Conclusions: These results suggest that mini-tablets with a 24% Eudragit enteric coating are suitable for targeted release of orally delivered V565 in the intestine for topical treatment of IBD.
International journal of pharmaceutics, Jan 3, 2015
A meeting organised by the Academy of Pharmaceutical Sciences (APSGB) Age-Related Medicines Focus... more A meeting organised by the Academy of Pharmaceutical Sciences (APSGB) Age-Related Medicines Focus Group took place on the 19th of May 2015, in GlaxoSmithKline Ware, UK [*]. The meeting was the first of a planned series of disease specific meetings organised by APSGB. It was attended by a number of experts involved with the treatment and development of drugs for the older adult, including clinicians, pharmacists, academics, regulators and representatives from industry. The event created the platform to discuss the provision of medicines for the treatment of Parkinson's Disease (PD) from a pharmaceutical sciences perspective.
Journal of Pharmaceutical and Biomedical Analysis, 1989
The selection, development, definition and validation of selective stability-indicating procedure... more The selection, development, definition and validation of selective stability-indicating procedures for high-performance liquid chromatographic and thin-layer chromatographic analyses of ranitidine hydrochloride are described. The procedures used in conjunction can be applied to the quality assurance and stability assessments of both the drug substance and its dosage forms and serve to establish the identity, strength and purity of this drug used in the treatment of peptic ulcer and related conditions.
Journal of Pharmaceutical and Biomedical Analysis, 1990
System suitability tests are applied to chromatographic analytical methods to confirm the methods... more System suitability tests are applied to chromatographic analytical methods to confirm the methods' continuing suitability for use on different occasions following their initial validation. The paper discusses the checks and controls which have traditionally been applied, questions their appropriateness and makes recommendations for others that should be considered.
Journal of Pharmaceutical and Biomedical Analysis, 1990
Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodolo... more Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodology is now widely required in support of registration dossiers. Although some attempts are made at defining terms and some vague indications are sometimes provided within these guidelines, no clear advice is provided on how validations should be conducted and what results should be expected. In this paper it is attempted to suggest some practical approaches to conducting validation and in particular to the determination of accuracy, linearity and limit of detection/quantitation.
A meeting jointly organised by the Academy of Pharmaceutical Sciences (APSGB), the Geriatric Medi... more A meeting jointly organised by the Academy of Pharmaceutical Sciences (APSGB), the Geriatric Medicine Society and the UCL School of Pharmacy took place on the 13th of March 2013, in Stevenage, UK. The meeting was attended by a number of experts involved with the treatment and development of drugs for the older adult, including clinicians, pharmacists, academics, regulators and representatives from industry. The event created the platform to discuss the provision of medicines for older adults from a pharmaceutical sciences perspective. 'The use of medications in older patients is arguably the single most important health care intervention in the industrialized world'.
The Academy of Pharmaceutical Sciences (APSGB) is delighted to partner with the British Journal o... more The Academy of Pharmaceutical Sciences (APSGB) is delighted to partner with the British Journal of Pharmacy to publish key abstracts of posters presented at this year’s APS PharmSci Conference held at the University of Hertfordshire 5th to 7th September 2017. The Conference is the premier pharmaceutical sciences event in the UK focussing on ‘The Science of Medicines’ and covers all aspects related to the discovery, development, production and testing of drug products.
Pharmaceutics, 2021
Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuo... more Continuous manufacturing (CM) is defined as a process in which the input material(s) are continuously fed into and transformed, and the processed output materials are continuously removed from the system. CM can be considered as matching the FDA’s so-called ‘Desired State’ of pharmaceutical manufacturing in the twenty-first century as discussed in their 2004 publication on ‘Innovation and Continuous Improvement in Pharmaceutical Manufacturing’. Yet, focused attention on CM did not really start until 2014, and the first product manufactured by CM was only approved in 2015. This review describes some of the benefits and challenges of introducing a CM process with a particular focus on small molecule solid oral dosage forms. The review is a useful introduction for individuals wishing to learn more about CM.
Pharmaceutics, May 3, 2019
A special symposium of the Academy of Pharmaceutical Sciences Nanomedicines Focus Group reviewed ... more A special symposium of the Academy of Pharmaceutical Sciences Nanomedicines Focus Group reviewed the current status of the use of nanomedicines for the delivery of biologics drugs. This meeting was particularly timely with the recent approval of the first siRNA-containing product Onpattro™ (patisiran), which is formulated as a lipid nanoparticle for intravenous infusion, and the increasing interest in the use of nanomedicines for the oral delivery of biologics. The challenges in delivering such molecules were discussed with specific emphasis on the delivery both across and into cells. The latest developments in Molecular Envelope Technology ® (Nanomerics Ltd, London, UK), liposomal drug delivery (both from an academic and industrial perspective), opportunities offered by the endocytic pathway, delivery using genetically engineered viral vectors (PsiOxus Technologies Ltd, Abingdon, UK), Transint™ technology (Applied Molecular Transport Inc., South San Francisco, CA, USA), which has the potential to deliver a wide range of macromolecules, and AstraZeneca's initiatives in mRNA delivery were covered with a focus on their uses in difficult to treat diseases, including cancers. Preclinical data were presented for each of the technologies and where sufficiently advanced, plans for clinical studies as well as early clinical data. The meeting covered the work in progress in this exciting area and highlighted some key technologies to look out for in the future.
Pharmaceutics
A meeting organised by the Academy of Pharmaceutical Sciences focussed on the challenges of devel... more A meeting organised by the Academy of Pharmaceutical Sciences focussed on the challenges of developing medicines for older adults. International experts discussed the complexity introduced by polypharmacy and multiple morbidities and how the risk–benefit ratio of a medicine changes as an individual ages. The way in which regulatory authorities are encouraging the development of age-appropriate medicines was highlighted. Examples were provided of the difficulties faced by the older population with some medicinal products and suggestions given as to how the pharmaceutical scientist can build the requirements of the older population into their development of new medicines, as well as improvements to existing ones.
British Journal of Pharmacy
Drug Development and Industrial Pharmacy
Objective: V565 is a novel oral anti-tumor necrosis factor (TNF)-a domain antibody being develope... more Objective: V565 is a novel oral anti-tumor necrosis factor (TNF)-a domain antibody being developed for topical treatment of inflammatory bowel disease (IBD) patients. Protein engineering rendered the molecule resistant to intestinal proteases. Here we investigate the formulation of V565 required to provide gastro-protection and enable optimal delivery to the lower intestinal tract in monkeys. Methods: Enteric-coated V565 mini-tablets were prepared and dissolution characteristics tested in vitro. Oral dosing of monkeys with enteric-coated mini-tablets containing V565 and methylene blue dye enabled in vivo localization of mini-tablet dissolution. V565 distribution in luminal contents and feces was measured by enzyme-linked immunosorbent assay (ELISA). To mimic transit across the damaged intestinal epithelium seen in IBD patients an intravenous (i.v.) bolus of V565 was given to monkeys and pharmacokinetic parameters of V565 measured in serum and urine by ELISA. Results: Enteric-coated mini-tablets resisted dissolution in 0.1 M HCl, before dissolving in a sustained release fashion at neutral pH. In orally dosed monkeys methylene blue intestinal staining indicated the jejunum and ileum as sites for mini-tablet dissolution. Measurements of V565 in monkey feces confirmed V565 survival through the intestinal tract. Systemic exposure after oral dosing was very low consistent with limited V565 mucosal penetration in healthy monkeys. The rapid clearance of V565 after i.v. dosing was consistent with renal excretion as the primary route for elimination of any V565 reaching the circulation. Conclusions: These results suggest that mini-tablets with a 24% Eudragit enteric coating are suitable for targeted release of orally delivered V565 in the intestine for topical treatment of IBD.
International journal of pharmaceutics, Jan 3, 2015
A meeting organised by the Academy of Pharmaceutical Sciences (APSGB) Age-Related Medicines Focus... more A meeting organised by the Academy of Pharmaceutical Sciences (APSGB) Age-Related Medicines Focus Group took place on the 19th of May 2015, in GlaxoSmithKline Ware, UK [*]. The meeting was the first of a planned series of disease specific meetings organised by APSGB. It was attended by a number of experts involved with the treatment and development of drugs for the older adult, including clinicians, pharmacists, academics, regulators and representatives from industry. The event created the platform to discuss the provision of medicines for the treatment of Parkinson's Disease (PD) from a pharmaceutical sciences perspective.
Journal of Pharmaceutical and Biomedical Analysis, 1989
The selection, development, definition and validation of selective stability-indicating procedure... more The selection, development, definition and validation of selective stability-indicating procedures for high-performance liquid chromatographic and thin-layer chromatographic analyses of ranitidine hydrochloride are described. The procedures used in conjunction can be applied to the quality assurance and stability assessments of both the drug substance and its dosage forms and serve to establish the identity, strength and purity of this drug used in the treatment of peptic ulcer and related conditions.
Journal of Pharmaceutical and Biomedical Analysis, 1990
System suitability tests are applied to chromatographic analytical methods to confirm the methods... more System suitability tests are applied to chromatographic analytical methods to confirm the methods' continuing suitability for use on different occasions following their initial validation. The paper discusses the checks and controls which have traditionally been applied, questions their appropriateness and makes recommendations for others that should be considered.
Journal of Pharmaceutical and Biomedical Analysis, 1990
Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodolo... more Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodology is now widely required in support of registration dossiers. Although some attempts are made at defining terms and some vague indications are sometimes provided within these guidelines, no clear advice is provided on how validations should be conducted and what results should be expected. In this paper it is attempted to suggest some practical approaches to conducting validation and in particular to the determination of accuracy, linearity and limit of detection/quantitation.
A meeting jointly organised by the Academy of Pharmaceutical Sciences (APSGB), the Geriatric Medi... more A meeting jointly organised by the Academy of Pharmaceutical Sciences (APSGB), the Geriatric Medicine Society and the UCL School of Pharmacy took place on the 13th of March 2013, in Stevenage, UK. The meeting was attended by a number of experts involved with the treatment and development of drugs for the older adult, including clinicians, pharmacists, academics, regulators and representatives from industry. The event created the platform to discuss the provision of medicines for older adults from a pharmaceutical sciences perspective. 'The use of medications in older patients is arguably the single most important health care intervention in the industrialized world'.